{
    "info": {
        "nct_id": "NCT04000282",
        "official_title": "An Open-label, First-in-human, Single Agent, Dose-escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442085 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria :\n\n* Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is >18 years old, at the time of signing the informed consent.\n* Participant has given voluntary written informed consent.\n* Participant has been previousy diagnosed with multiple myeloma based on standard criteria.\n* Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide), at least 1 anti-CD38 monoclonal antibody and at least 1 steroid. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards. (3) Participant had at least a minimal response (MR) to the anti-CD38 antibody containing regimen and had last dose of anti-CD38 monoclonal antibody at least 9 months prior to study entry. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards.\n* Part B and the last cohort(s) of Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide) and at least 1 steroid. (3) Prior therapy has not included an anti-CD38 monoclonal antibody.\n* Participant has myeloma disease progression on or after last therapy.\n* Participant must have measurable disease as defined as at least one of the following:\n\n  * Serum M protein ≥0.5 g/dL (≥5 g/L)\n  * Urine M protein ≥200 mg/24 hours\n  * Serum FLC assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum\n  * FLC ratio (<0.26 or >1.65).\n* A male participant must agree to use contraception during the intervention period and for at least 150 days after the last dose of study drug and refrain from donating sperm during this period.\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 150 days after the last dose of study intervention.\n\nExclusion criteria:\n\n* Participant is diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, superficial bladder carcinoma or low risk prostate cancer.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score >2.\n* Participant has a history of Chronic obstructive pulmonary disease (COPD) or asthma.\n* Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline (exception: alopecia).\n* Participant has congestive heart failure (New York Heart Association) Grade ≥II; cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension, QT interval corrected by the Fridericia method >480 msec (Grade ≥2).\n* Participant has had acute myocardial infarction within 6 months before first dose of study medication.\n* Participant has ongoing sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥3.\n* Participant has active autoimmune disease including autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis or any chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily.\n* Known acquired immunodeficiency syndrome (AIDS) or related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or to have active hepatitis A, B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA), or C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen) infection.\n* Participant has positive Coombs test at baseline.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "* Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is >18 years old, at the time of signing the informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Participant must be at least 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "or of the country's legal age of majority if the legal age is >18 years old",
                        "criterion": "legal age of majority",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participant must be at least 18 years of age",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "minimum age",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "or of the country's legal age of majority if the legal age is >18 years old",
                                    "criterion": "legal age of majority",
                                    "requirement": {
                                        "requirement_type": "minimum age",
                                        "expected_value": {
                                            "operator": ">",
                                            "value": 18,
                                            "unit": "years"
                                        }
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "or of the country's legal age of majority if the legal age is >18 years old",
                                "criterion": "legal age of majority",
                                "requirement": {
                                    "requirement_type": "minimum age",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "or of the country's legal age of majority if the legal age is >18 years old",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "minimum age",
                                    "expected_value": "legal age of majority"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant has given voluntary written informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Participant has given voluntary written informed consent.",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Participant has given voluntary written informed consent.",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant has been previousy diagnosed with multiple myeloma based on standard criteria.",
                "criterions": [
                    {
                        "exact_snippets": "Participant has been previousy diagnosed with multiple myeloma",
                        "criterion": "multiple myeloma diagnosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Participant has been previousy diagnosed with multiple myeloma",
                        "criterion": "multiple myeloma diagnosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Part B and the last cohort(s) of Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide) and at least 1 steroid. (3) Prior therapy has not included an anti-CD38 monoclonal antibody.",
                "criterions": [
                    {
                        "exact_snippets": "participant has received at least 3 prior lines of therapy for multiple myeloma",
                        "criterion": "prior lines of therapy for multiple myeloma",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "lines"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens",
                        "criterion": "prior lines of therapy with multi-agent regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens",
                        "criterion": "prior lines of therapy with multi-agent regimens",
                        "requirement": {
                            "requirement_type": "multi-agent regimens",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib)",
                        "criterion": "prior therapy with proteasome inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included ... at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide)",
                        "criterion": "prior therapy with immunomodulatory agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included ... at least 1 steroid",
                        "criterion": "prior therapy with steroid",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy has not included an anti-CD38 monoclonal antibody",
                        "criterion": "prior therapy with anti-CD38 monoclonal antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "participant has received at least 3 prior lines of therapy for multiple myeloma",
                                        "criterion": "prior lines of therapy for multiple myeloma",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "lines"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens",
                                        "criterion": "prior lines of therapy with multi-agent regimens",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "lines"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens",
                                        "criterion": "prior lines of therapy with multi-agent regimens",
                                        "requirement": {
                                            "requirement_type": "multi-agent regimens",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "regimens"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib)",
                        "criterion": "prior therapy with proteasome inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included ... at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide)",
                        "criterion": "prior therapy with immunomodulatory agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included ... at least 1 steroid",
                        "criterion": "prior therapy with steroid",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy has not included an anti-CD38 monoclonal antibody",
                        "criterion": "prior therapy with anti-CD38 monoclonal antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant has myeloma disease progression on or after last therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Participant has myeloma disease progression",
                        "criterion": "myeloma disease progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "on or after last therapy",
                        "criterion": "timing of progression",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "on or after last therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Participant has myeloma disease progression",
                        "criterion": "myeloma disease progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "on or after last therapy",
                        "criterion": "timing of progression",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "on or after last therapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant must have measurable disease as defined as at least one of the following:",
                "criterions": [
                    {
                        "exact_snippets": "Participant must have measurable disease",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Participant must have measurable disease",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Urine M protein ≥200 mg/24 hours",
                "criterions": [
                    {
                        "exact_snippets": "Urine M protein ≥200 mg/24 hours",
                        "criterion": "Urine M protein",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 200,
                                "unit": "mg/24 hours"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Urine M protein ≥200 mg/24 hours",
                        "criterion": "Urine M protein",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 200,
                                "unit": "mg/24 hours"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serum FLC assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum",
                "criterions": [
                    {
                        "exact_snippets": "Serum FLC assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L)",
                        "criterion": "involved FLC assay",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Serum FLC assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L)",
                        "criterion": "involved FLC assay",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "mg/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "abnormal serum",
                        "criterion": "serum",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serum FLC assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L)",
                                "criterion": "involved FLC assay",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "mg/dL"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Serum FLC assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L)",
                                "criterion": "involved FLC assay",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 100,
                                        "unit": "mg/L"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "abnormal serum",
                        "criterion": "serum",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* A male participant must agree to use contraception during the intervention period and for at least 150 days after the last dose of study drug and refrain from donating sperm during this period.",
                "criterions": [
                    {
                        "exact_snippets": "A male participant",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "must agree to use contraception during the intervention period and for at least 150 days after the last dose of study drug",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the intervention period and for at least 150 days after the last dose of study drug"
                        }
                    },
                    {
                        "exact_snippets": "refrain from donating sperm during this period",
                        "criterion": "sperm donation",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "refrain"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "A male participant",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "expected_value",
                                    "expected_value": "male"
                                }
                            },
                            {
                                "exact_snippets": "must agree to use contraception during the intervention period and for at least 150 days after the last dose of study drug",
                                "criterion": "contraception use",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": "during the intervention period and for at least 150 days after the last dose of study drug"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "refrain from donating sperm during this period",
                        "criterion": "sperm donation",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "refrain"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:",
                "criterions": [
                    {
                        "exact_snippets": "female participant",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "not pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not breastfeeding",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "female participant",
                            "criterion": "gender",
                            "requirement": {
                                "requirement_type": "value",
                                "expected_value": "female"
                            }
                        },
                        {
                            "exact_snippets": "not pregnant",
                            "criterion": "pregnancy status",
                            "requirement": {
                                "requirement_type": "status",
                                "expected_value": false
                            }
                        },
                        {
                            "exact_snippets": "not breastfeeding",
                            "criterion": "breastfeeding status",
                            "requirement": {
                                "requirement_type": "status",
                                "expected_value": false
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Not a woman of childbearing potential (WOCBP)",
                "criterions": [
                    {
                        "exact_snippets": "Not a woman of childbearing potential (WOCBP)",
                        "criterion": "woman of childbearing potential",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Not a woman of childbearing potential (WOCBP)",
                        "criterion": "woman of childbearing potential",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 150 days after the last dose of study intervention.",
                "criterions": [
                    {
                        "exact_snippets": "A WOCBP who agrees to follow the contraceptive guidance",
                        "criterion": "WOCBP (woman of childbearing potential)",
                        "requirement": {
                            "requirement_type": "agreement to follow contraceptive guidance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "during the intervention period and for at least 150 days after the last dose of study intervention",
                        "criterion": "duration of contraceptive guidance",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 150,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "A WOCBP who agrees to follow the contraceptive guidance",
                        "criterion": "WOCBP (woman of childbearing potential)",
                        "requirement": {
                            "requirement_type": "agreement to follow contraceptive guidance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "during the intervention period and for at least 150 days after the last dose of study intervention",
                        "criterion": "duration of contraceptive guidance",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 150,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant is diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, superficial bladder carcinoma or low risk prostate cancer.",
                "criterions": [
                    {
                        "exact_snippets": "Participant is diagnosed or treated for another malignancy within 3 years prior to enrollment",
                        "criterion": "diagnosis or treatment of another malignancy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "with the exception of basal cell carcinoma or squamous cell carcinoma of the skin",
                        "criterion": "basal cell carcinoma or squamous cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "with the exception of ... an in situ malignancy",
                        "criterion": "in situ malignancy",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "with the exception of ... superficial bladder carcinoma",
                        "criterion": "superficial bladder carcinoma",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "with the exception of ... low risk prostate cancer",
                        "criterion": "low risk prostate cancer",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Participant is diagnosed or treated for another malignancy within 3 years prior to enrollment",
                            "criterion": "diagnosis or treatment of another malignancy",
                            "requirement": {
                                "requirement_type": "time frame",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<=",
                                            "value": 3,
                                            "unit": "years"
                                        }
                                    ]
                                }
                            }
                        },
                        {
                            "not_criteria": {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "with the exception of basal cell carcinoma or squamous cell carcinoma of the skin",
                                        "criterion": "basal cell carcinoma or squamous cell carcinoma of the skin",
                                        "requirement": {
                                            "requirement_type": "exclusion",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "with the exception of ... an in situ malignancy",
                                        "criterion": "in situ malignancy",
                                        "requirement": {
                                            "requirement_type": "exclusion",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "with the exception of ... superficial bladder carcinoma",
                                        "criterion": "superficial bladder carcinoma",
                                        "requirement": {
                                            "requirement_type": "exclusion",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "with the exception of ... low risk prostate cancer",
                                        "criterion": "low risk prostate cancer",
                                        "requirement": {
                                            "requirement_type": "exclusion",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "Participant is diagnosed or treated for another malignancy within 3 years prior to enrollment",
                    "criterion": "diagnosis or treatment of another malignancy",
                    "requirement": {
                        "requirement_type": "time frame",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 3,
                                    "unit": "years"
                                }
                            ]
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score >2.",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score >2",
                        "criterion": "ECOG performance status score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score >2",
                    "criterion": "ECOG performance status score",
                    "requirement": {
                        "requirement_type": "score",
                        "expected_value": {
                            "operator": ">",
                            "value": 2,
                            "unit": "N/A"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Participant has a history of Chronic obstructive pulmonary disease (COPD) or asthma.",
                "criterions": [
                    {
                        "exact_snippets": "history of Chronic obstructive pulmonary disease (COPD)",
                        "criterion": "Chronic obstructive pulmonary disease (COPD)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of ... asthma",
                        "criterion": "asthma",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "history of Chronic obstructive pulmonary disease (COPD)",
                        "criterion": "Chronic obstructive pulmonary disease (COPD)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of ... asthma",
                        "criterion": "asthma",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline (exception: alopecia).",
                "criterions": [
                    {
                        "exact_snippets": "Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy)",
                        "criterion": "recovery from adverse reactions to prior myeloma treatment or procedures",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "NCI CTCAE Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Participant has not recovered from adverse reactions to prior myeloma treatment or procedures ... to ... baseline",
                        "criterion": "recovery from adverse reactions to prior myeloma treatment or procedures",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "baseline"
                        }
                    },
                    {
                        "exact_snippets": "exception: alopecia",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "not_criteria": {
                                            "exact_snippets": "Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy)",
                                            "criterion": "recovery from adverse reactions to prior myeloma treatment or procedures",
                                            "requirement": {
                                                "requirement_type": "severity",
                                                "expected_value": {
                                                    "operator": "<=",
                                                    "value": 1,
                                                    "unit": "NCI CTCAE Grade"
                                                }
                                            }
                                        }
                                    },
                                    {
                                        "not_criteria": {
                                            "exact_snippets": "Participant has not recovered from adverse reactions to prior myeloma treatment or procedures ... to ... baseline",
                                            "criterion": "recovery from adverse reactions to prior myeloma treatment or procedures",
                                            "requirement": {
                                                "requirement_type": "severity",
                                                "expected_value": "baseline"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "exception: alopecia",
                                "criterion": "alopecia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant has congestive heart failure (New York Heart Association) Grade ≥II; cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension, QT interval corrected by the Fridericia method >480 msec (Grade ≥2).",
                "criterions": [
                    {
                        "exact_snippets": "congestive heart failure (New York Heart Association) Grade ≥II",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NYHA Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "cardiac myopathy",
                        "criterion": "cardiac myopathy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active ischemia",
                        "criterion": "active ischemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled cardiac condition such as angina pectoris",
                        "criterion": "uncontrolled cardiac condition",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "angina pectoris"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "clinically significant arrhythmia requiring therapy including anticoagulants",
                        "criterion": "clinically significant arrhythmia",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "therapy including anticoagulants"
                        }
                    },
                    {
                        "exact_snippets": "clinically significant uncontrolled hypertension",
                        "criterion": "clinically significant uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "QT interval corrected by the Fridericia method >480 msec",
                        "criterion": "QT interval",
                        "requirement": {
                            "requirement_type": "corrected by the Fridericia method",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "congestive heart failure (New York Heart Association) Grade ≥II",
                                "criterion": "congestive heart failure",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "NYHA Grade"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "cardiac myopathy",
                                "criterion": "cardiac myopathy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "active ischemia",
                                "criterion": "active ischemia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "uncontrolled cardiac condition such as angina pectoris",
                                "criterion": "uncontrolled cardiac condition",
                                "requirement": {
                                    "requirement_type": "examples",
                                    "expected_value": [
                                        "angina pectoris"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "clinically significant arrhythmia requiring therapy including anticoagulants",
                                "criterion": "clinically significant arrhythmia",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "therapy including anticoagulants"
                                }
                            },
                            {
                                "exact_snippets": "clinically significant uncontrolled hypertension",
                                "criterion": "clinically significant uncontrolled hypertension",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "QT interval corrected by the Fridericia method >480 msec",
                                "criterion": "QT interval",
                                "requirement": {
                                    "requirement_type": "corrected by the Fridericia method",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 480,
                                        "unit": "msec"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant has had acute myocardial infarction within 6 months before first dose of study medication.",
                "criterions": [
                    {
                        "exact_snippets": "acute myocardial infarction within 6 months before first dose of study medication",
                        "criterion": "acute myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "acute myocardial infarction within 6 months before first dose of study medication",
                    "criterion": "acute myocardial infarction",
                    "requirement": {
                        "requirement_type": "time since event",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 6,
                                    "unit": "months"
                                }
                            ]
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Participant has active autoimmune disease including autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis or any chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily.",
                "criterions": [
                    {
                        "exact_snippets": "active autoimmune disease",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "autoimmune hemolytic anemia",
                        "criterion": "autoimmune hemolytic anemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "idiopathic thrombocytopenic purpura",
                        "criterion": "idiopathic thrombocytopenic purpura",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "inflammatory bowel syndrome",
                        "criterion": "inflammatory bowel syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pneumonitis",
                        "criterion": "pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily",
                        "criterion": "corticosteroid requirement",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active autoimmune disease",
                                "criterion": "autoimmune disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "autoimmune hemolytic anemia",
                                "criterion": "autoimmune hemolytic anemia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active autoimmune disease",
                                "criterion": "autoimmune disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "idiopathic thrombocytopenic purpura",
                                "criterion": "idiopathic thrombocytopenic purpura",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active autoimmune disease",
                                "criterion": "autoimmune disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "inflammatory bowel syndrome",
                                "criterion": "inflammatory bowel syndrome",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active autoimmune disease",
                                "criterion": "autoimmune disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "pneumonitis",
                                "criterion": "pneumonitis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily",
                        "criterion": "corticosteroid requirement",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant has positive Coombs test at baseline.",
                "criterions": [
                    {
                        "exact_snippets": "positive Coombs test",
                        "criterion": "Coombs test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "positive Coombs test",
                        "criterion": "Coombs test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Inclusion criteria :",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "* Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide), at least 1 anti-CD38 monoclonal antibody and at least 1 steroid. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards. (3) Participant had at least a minimal response (MR) to the anti-CD38 antibody containing regimen and had last dose of anti-CD38 monoclonal antibody at least 9 months prior to study entry. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards.",
                "criterions": [
                    {
                        "exact_snippets": "participant has received at least 3 prior lines of therapy for multiple myeloma",
                        "criterion": "prior lines of therapy for multiple myeloma",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "lines"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens",
                        "criterion": "prior lines of therapy with multi-agent regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens",
                        "criterion": "prior lines of therapy with multi-agent regimens",
                        "requirement": {
                            "requirement_type": "multi-agent regimens",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib)",
                        "criterion": "prior therapy with proteasome inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide)",
                        "criterion": "prior therapy with immunomodulatory agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included at least 1 anti-CD38 monoclonal antibody",
                        "criterion": "prior therapy with anti-CD38 monoclonal antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included at least 1 steroid",
                        "criterion": "prior therapy with steroid",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Participant had at least a minimal response (MR) to the anti-CD38 antibody containing regimen",
                        "criterion": "response to anti-CD38 antibody containing regimen",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": "minimal response (MR)"
                        }
                    },
                    {
                        "exact_snippets": "had last dose of anti-CD38 monoclonal antibody at least 9 months prior to study entry",
                        "criterion": "time since last dose of anti-CD38 monoclonal antibody",
                        "requirement": {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "participant has received at least 3 prior lines of therapy for multiple myeloma",
                                        "criterion": "prior lines of therapy for multiple myeloma",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "lines"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens",
                                        "criterion": "prior lines of therapy with multi-agent regimens",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "lines"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens",
                                        "criterion": "prior lines of therapy with multi-agent regimens",
                                        "requirement": {
                                            "requirement_type": "multi-agent regimens",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 1,
                                                "unit": "lines"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib)",
                        "criterion": "prior therapy with proteasome inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide)",
                        "criterion": "prior therapy with immunomodulatory agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included at least 1 anti-CD38 monoclonal antibody",
                        "criterion": "prior therapy with anti-CD38 monoclonal antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy for multiple myeloma has included at least 1 steroid",
                        "criterion": "prior therapy with steroid",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Participant had at least a minimal response (MR) to the anti-CD38 antibody containing regimen",
                        "criterion": "response to anti-CD38 antibody containing regimen",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": "minimal response (MR)"
                        }
                    },
                    {
                        "exact_snippets": "had last dose of anti-CD38 monoclonal antibody at least 9 months prior to study entry",
                        "criterion": "time since last dose of anti-CD38 monoclonal antibody",
                        "requirement": {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Exclusion criteria:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "* Participant has ongoing sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥3.",
                "criterions": [
                    {
                        "exact_snippets": "ongoing sensory or motor neuropathy ... NCI CTCAE Grade ≥3",
                        "criterion": "sensory or motor neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "NCI CTCAE Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "ongoing sensory or motor neuropathy ... NCI CTCAE Grade ≥3",
                    "criterion": "sensory or motor neuropathy",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": {
                            "operator": ">=",
                            "value": 3,
                            "unit": "NCI CTCAE Grade"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Known acquired immunodeficiency syndrome (AIDS) or related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or to have active hepatitis A, B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA), or C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen) infection.",
                "criterions": [
                    {
                        "exact_snippets": "Known acquired immunodeficiency syndrome (AIDS)",
                        "criterion": "acquired immunodeficiency syndrome (AIDS)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "related illnesses",
                        "criterion": "related illnesses to AIDS",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "human immunodeficiency virus (HIV) disease requiring antiretroviral treatment",
                        "criterion": "HIV disease",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": "antiretroviral treatment"
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis A",
                        "criterion": "hepatitis A infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA)",
                        "criterion": "hepatitis B infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA)",
                        "criterion": "hepatitis B infection",
                        "requirement": {
                            "requirement_type": "HBsAg result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA)",
                        "criterion": "hepatitis B infection",
                        "requirement": {
                            "requirement_type": "HepB DNA",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen)",
                        "criterion": "hepatitis C infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen)",
                        "criterion": "hepatitis C infection",
                        "requirement": {
                            "requirement_type": "HCV RNA results",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "lower limits of detection of the assay"
                            }
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen)",
                        "criterion": "hepatitis C infection",
                        "requirement": {
                            "requirement_type": "HCV antigen",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Known acquired immunodeficiency syndrome (AIDS)",
                                        "criterion": "acquired immunodeficiency syndrome (AIDS)",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "related illnesses",
                                        "criterion": "related illnesses to AIDS",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "human immunodeficiency virus (HIV) disease requiring antiretroviral treatment",
                                "criterion": "HIV disease",
                                "requirement": {
                                    "requirement_type": "treatment requirement",
                                    "expected_value": "antiretroviral treatment"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "active hepatitis A",
                        "criterion": "hepatitis A infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active hepatitis B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA)",
                                "criterion": "hepatitis B infection",
                                "requirement": {
                                    "requirement_type": "activity",
                                    "expected_value": "active"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "active hepatitis B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA)",
                                        "criterion": "hepatitis B infection",
                                        "requirement": {
                                            "requirement_type": "HBsAg result",
                                            "expected_value": "positive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "active hepatitis B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA)",
                                        "criterion": "hepatitis B infection",
                                        "requirement": {
                                            "requirement_type": "HepB DNA",
                                            "expected_value": "positive"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active hepatitis C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen)",
                                "criterion": "hepatitis C infection",
                                "requirement": {
                                    "requirement_type": "activity",
                                    "expected_value": "active"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "active hepatitis C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen)",
                                        "criterion": "hepatitis C infection",
                                        "requirement": {
                                            "requirement_type": "HCV RNA results",
                                            "expected_value": {
                                                "operator": ">",
                                                "value": 0,
                                                "unit": "lower limits of detection of the assay"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "active hepatitis C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen)",
                                        "criterion": "hepatitis C infection",
                                        "requirement": {
                                            "requirement_type": "HCV antigen",
                                            "expected_value": "positive"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "* Serum M protein ≥0.5 g/dL (≥5 g/L)",
                "criterions": [
                    {
                        "exact_snippets": "Serum M protein ≥0.5 g/dL (≥5 g/L)",
                        "criterion": "Serum M protein",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0.5,
                                        "unit": "g/dL"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "g/L"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serum M protein \u0003\u000e0.5 g/dL (\u000e5 g/L)",
                        "criterion": "Serum M protein",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0.5,
                                        "unit": "g/dL"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "g/L"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* FLC ratio (<0.26 or >1.65).",
                "criterions": [
                    {
                        "exact_snippets": "FLC ratio (<0.26 or >1.65)",
                        "criterion": "FLC ratio",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 0.26,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": ">",
                                        "value": 1.65,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "FLC ratio (<0.26 or >1.65)",
                        "criterion": "FLC ratio",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 0.26,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "FLC ratio (<0.26 or >1.65)",
                        "criterion": "FLC ratio",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 1.65,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        }
    ]
}