{
    "info": {
        "nct_id": "NCT01750762",
        "official_title": "Phase I Study of Lenalidomide to Augment Anti-Tumor Immunity Following Allogeneic Transplantation",
        "inclusion_criteria": "* Histologically confirmed multiple myeloma or lymphoma and evidence of disease at least 100 days after an allogeneic stem cell or bone marrow transplantation\n* Lymphoma patients must have measurable disease\n* No previous cancer therapy within 4 weeks\n* Life expectancy of at least 3 months\n* Free of prior malignancies for at least 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast\n* Must be registered into RevAssist program and willing and able to comply with RevAssist requirements\n* Willing to commit to abstinence or use one highly effective method of birth control and another effective method of birth control at the same time\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnant or breastfeeding\n* Any other serious medical condition\n* Any condition that places the subject at unacceptable risk if he/she were to participate in the study\n* Use of experimental drug or therapy within 28 days of baseline\n* Known significant hypersensitivity to thalidomide or lenalidomide\n* Development of erythema nodosum if characterized by desquamating rash while taking thalidomide or similar drugs\n* Chemotherapy or radiotherapy within 4 weeks\n* Known seropositive for acute HIV, hepatitis B or C\n* Significant concurrent infections\n* Non-hematological acute GvHD and/or hematological toxicity of Grade 3 or higher\n* Moderate or severe chronic GVHD",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed multiple myeloma or lymphoma and evidence of disease at least 100 days after an allogeneic stem cell or bone marrow transplantation",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed multiple myeloma",
                    "criterion": "multiple myeloma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... lymphoma",
                    "criterion": "lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of disease",
                    "criterion": "disease evidence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 100 days after an allogeneic stem cell or bone marrow transplantation",
                    "criterion": "time since transplantation",
                    "requirements": [
                        {
                            "requirement_type": "time since transplantation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lymphoma patients must have measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Lymphoma patients must have measurable disease",
                    "criterion": "lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Lymphoma patients must have measurable disease",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous cancer therapy within 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "No previous cancer therapy within 4 weeks",
                    "criterion": "previous cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Free of prior malignancies for at least 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast",
            "criterions": [
                {
                    "exact_snippets": "Free of prior malignancies for at least 5 years",
                    "criterion": "prior malignancies",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of currently treated basal cell, squamous cell carcinoma of the skin",
                    "criterion": "currently treated basal cell, squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of ... carcinoma in situ of the cervix or breast",
                    "criterion": "carcinoma in situ of the cervix or breast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be registered into RevAssist program and willing and able to comply with RevAssist requirements",
            "criterions": [
                {
                    "exact_snippets": "Must be registered into RevAssist program",
                    "criterion": "RevAssist program registration",
                    "requirements": [
                        {
                            "requirement_type": "registration",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing and able to comply with RevAssist requirements",
                    "criterion": "compliance with RevAssist requirements",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to commit to abstinence or use one highly effective method of birth control and another effective method of birth control at the same time",
            "criterions": [
                {
                    "exact_snippets": "Willing to commit to abstinence",
                    "criterion": "abstinence commitment",
                    "requirements": [
                        {
                            "requirement_type": "commitment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use one highly effective method of birth control",
                    "criterion": "highly effective birth control method",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use ... another effective method of birth control at the same time",
                    "criterion": "another effective birth control method",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other serious medical condition",
            "criterions": [
                {
                    "exact_snippets": "serious medical condition",
                    "criterion": "serious medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition that places the subject at unacceptable risk if he/she were to participate in the study",
            "criterions": [
                {
                    "exact_snippets": "Any condition that places the subject at unacceptable risk",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "unacceptable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of experimental drug or therapy within 28 days of baseline",
            "criterions": [
                {
                    "exact_snippets": "Use of experimental drug or therapy within 28 days of baseline",
                    "criterion": "use of experimental drug or therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known significant hypersensitivity to thalidomide or lenalidomide",
            "criterions": [
                {
                    "exact_snippets": "Known significant hypersensitivity to thalidomide",
                    "criterion": "hypersensitivity to thalidomide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known significant hypersensitivity to ... lenalidomide",
                    "criterion": "hypersensitivity to lenalidomide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Development of erythema nodosum if characterized by desquamating rash while taking thalidomide or similar drugs",
            "criterions": [
                {
                    "exact_snippets": "Development of erythema nodosum",
                    "criterion": "erythema nodosum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "desquamating rash",
                    "criterion": "desquamating rash",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "taking thalidomide or similar drugs",
                    "criterion": "thalidomide or similar drugs",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy or radiotherapy within 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy ... within 4 weeks",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy within 4 weeks",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant concurrent infections",
            "criterions": [
                {
                    "exact_snippets": "Significant concurrent infections",
                    "criterion": "concurrent infections",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-hematological acute GvHD and/or hematological toxicity of Grade 3 or higher",
            "criterions": [
                {
                    "exact_snippets": "Non-hematological acute GvHD",
                    "criterion": "non-hematological acute GvHD",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hematological toxicity of Grade 3 or higher",
                    "criterion": "hematological toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Moderate or severe chronic GVHD",
            "criterions": [
                {
                    "exact_snippets": "Moderate or severe chronic GVHD",
                    "criterion": "chronic GVHD",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "moderate",
                                "severe"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Known seropositive for acute HIV, hepatitis B or C",
            "criterions": [
                {
                    "exact_snippets": "Known seropositive for acute HIV",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "seropositivity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "seropositive for ... hepatitis B",
                    "criterion": "hepatitis B status",
                    "requirements": [
                        {
                            "requirement_type": "seropositivity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "seropositive for ... hepatitis C",
                    "criterion": "hepatitis C status",
                    "requirements": [
                        {
                            "requirement_type": "seropositivity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}