[c09aa8]: / clusters / 9knumclustersv2 / clust_1445.txt

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Males or females with multiple myeloma who have exhausted available standard therapies.
Anti-myeloma treatment within weeks
Patients with relapse/ refractory multiple myeloma
Hematologic malignancies (including lymphoma, multiple myeloma)
Use of any myeloma-specific therapy within days of the MILs collection
Myeloma specific therapy with a minimum of cycles
Ineligible disease sites include the following\r\n* Lymphoma\r\n* Leukemia\r\n* Multiple myeloma\r\n* Primary CNS\r\n* Peritoneal carcinomatosis \r\n* Colon cancer with resectable liver-only lesions
B-CLL or recurrent or refractory B-cell lymphoma (or other B-cell neoplasm) or multiple myeloma monoclonal for Kappa-light chain
Any prior therapy for symptomatic multiple myeloma or smoldering multiple myeloma should also be excluded, including prior use of IMIDs, proteasome inhibitors, or CD inhibitors; prior therapy for smoldering multiple myeloma with agents that are not therapeutically active against MM is not an exclusion criterion
Is in need of additional myeloma therapy as determined by the investigator.
Patients with high risk multiple myeloma (criterion a above) in very good partial response (VGPR) or better at the time of enrollment with at most prior progression within months from initiation of systemic anti-myeloma therapy, which may include single or planned tandem autologous HSCT; or
Patients with standard risk multiple myeloma in VGPR or better at the time of enrollment with prior progression within months from a single or planned tandem autologous HSCT; or
multiple myeloma
Symptomatic multiple myeloma, International Staging System (ISS) stages I-III, within months of starting therapy
COHORT A: multiple myeloma
Prior cytotoxic chemotherapy or corticosteroids for the treatment of multiple myeloma; NOTE: prior corticosteroid use for the treatment of non-malignant disorders is permitted
Multiple myeloma beyond PR: Patients with chromosome abnormalities, first response lasting less than months, or beta- microglobulin > mg/L, may be considered for this protocol after initial therapy
Relapsed or refractory hematologic malignancy (lymphoma or multiple myeloma) that has progressed, or is currently progressing with standard anticancer therapy or for which no other approved therapy exist. Lymphoma patients must have failed at least standard anticancer therapies, and multiple myeloma patients must have failed at least standard anticancer therapies.
Received systemic treatment for multiple myeloma, including immunotherapy, within days prior to initiation of study procedures
Any previous ASCT for multiple myeloma (MM)
Patients with multiple myeloma in first relapse (or who are primary refractory) following treatment with a bortezomib-containing regimen (excluding prior treatment with ixazomib)
Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies
Patients must meet the criteria for symptomatic multiple myeloma prior to initiating systemic anti-myeloma treatment.
Documented multiple myeloma as defined by the criteria below:
Smoldering (asymptomatic) multiple myeloma
Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone
Prior or concurrent systemic treatment for SMM; b) bisphosphonates are permitted, including pamidronate, zoledronic acid, alendronate, ibandronate, risedronate; c) treatment with corticosteroids is not permitted, unless the patient is on a stable chronic dose of inhaled steroids to treat respiratory diseases or on stable chronic steroid replacement therapy for endocrinology disorders; d) radiotherapy is not permitted, e) prior treatment for smoldering multiple myeloma with chemotherapy agents approved for the treatment of multiple myeloma or CD drugs is not permitted
Has received prior anti-myeloma therapy of any type
Histologic and serologic findings, reviewed at Memorial Sloan Kettering Cancer Center (MSKCC), confirming the diagnosis of multiple myeloma or AL amyloidosis; standard diagnostic criteria for multiple myeloma will be used, as per the International Myeloma Foundation consensus guidelines
Primary lesions with the following histologies: small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma
At time of enrollment, subjects must be within months of initiation of systemic therapy for multiple myeloma
Patients who have received > prior treatment regimens for multiple myeloma
Multiple myeloma beyond PR: Patients with chromosome abnormalities, first response lasting less than months, or beta- microglobulin > mg/L, may be considered for this protocol after initial therapy
Multiple myeloma progressive on salvage chemotherapy
Multiple myeloma specific:\r\n* Confirmed evidence of disease progression from immediately prior multiple myeloma (MM) therapy or refractory to the immediately prior treatment\r\n* Measurable disease M protein component in serum (at least . g/dL) and/or urine (if present), (>=. g excreted in a hour collection sample)\r\n* Subjects with free light chain only disease are excluded
Histologies of myeloma or lymphoma
Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within - months of the first dose of initial therapy
Administration or planned administration of any other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy which would be considered a treatment of multiple myeloma until day + post-transplant through discontinuation from study; patients may be on corticosteroids if they are being given for disorders other than multiple myeloma (e.g., adrenal insufficiency, rheumatoid arthritis, etc.)
Recent history of other (non multiple myeloma) cancer
Multiple myeloma\r\n* Relapse/progression after autologous HSCT\r\n* Plasma cell leukemia\r\n* Adverse cytogenetics: e.g. del(q) or q translocation\r\n* At the time of enrollment, multiple myeloma (MM) must be in complete remission
Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
Symptomatic multiple myeloma of any subtype in any disease stage, providing the patient does not have smoldering myeloma, and otherwise met standard criteria (hypercalcemia, renal dysfunction, anemia and/or bone lesions CRAB criteria) for induction therapy
Multiple Myeloma (> CR, > PR) or after initial therapy if no prior PR: recent chemotherapy responsiveness
Multiple myeloma beyond PR; patients with chromosome abnormalities, first response lasting less than months, or beta- microglobulin > mg/L, may be considered for this protocol after initial therapy
Multiple myeloma beyond PR: Patients with chromosome abnormalities, first response lasting less than months, or beta- microglobulin > mg/L, may be considered for this protocol after initial therapy
Patients must have one of the following diagnoses of multiple myeloma (MM) or primary/secondary myelofibrosis (MF)
Subject has previously been treated for multiple myeloma
Patient received chemotherapy or other anti-cancer therapy that may be active against multiple myeloma within weeks prior to the first dose of PRLX .
Patient is taking any therapy concomitantly that may be active against multiple myeloma.
Patient with confirmed multiple myeloma requiring systemic therapy. All three criteria must be met:
Patient whose disease progressed during or within days of bortezomib treatment or of any other Multiple Myeloma therapy
Multiple myeloma (Eligible patients must have quantifiable M-protein levels present in serum and/or urine)
Progressive disease must have occurred either during or subsequent to the patient's last treatment for multiple myeloma prior to the current enrollment
Patient must have substantially recovered from clinically significant toxicities from prior therapies for multiple myeloma
Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within - months of the first dose of initial therapy
Evidence of multiple myeloma (MM) disease progression any time prior to enrollment; progression from smoldering to active myeloma is not exclusionary
Patients with multiple myeloma in complete response (CR), partial remission (PR), very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain multiple myeloma (MM) detected in the serum by free light chain assay.
Planned concurrent treatment for multiple myeloma other than bisphosphonates
Diagnosis of multiple myeloma according to International Myeloma Working Group criteria and one of the following:\r\n* Smoldering multiple myeloma (SMM)\r\n* Indolent multiple myeloma (IMM)\r\n* Newly diagnosed multiple myeloma (MM)\r\n* Note: patients with lytic disease and anemia are eligible
Prior cytotoxic chemotherapy or corticosteroids for the treatment of multiple myeloma\r\n* NOTE: Prior corticosteroid use for the treatment of non-malignant disorders is permitted
FOR PATIENTS WITH MULTIPLE MYELOMA (MM):
Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within - months of the first dose of initial therapy
Smoldering multiple myeloma (MM) not requiring therapy
Multiple myeloma progressive on salvage chemotherapy
Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within - months of the first dose of initial therapy
MULTIPLE MYELOMA CRITERIA:
Patients must have received at least different prior treatment regimens for multiple myeloma
Any chemotherapy, immunotherapy, biologic, investigational, for treatment of multiple myeloma other than lenalidomide and dexamethasone
Previous systemic cancer therapy for myeloma
MULTIPLE MYELOMA CRITERIA
Participants must have documented symptomatic myeloma, with organ damage related to myeloma as defined above with laboratory assessments
Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted
multiple myeloma (MM)
Any one or more of the following myeloma defining events:
For Multiple Myeloma cohort
Four or less prior lines of systemic therapy for multiple myeloma
Must have had documented multiple myeloma
Must have received at least prior line of therapy for multiple myeloma
Has a history of malignancy (other than multiple myeloma) within years before the date of randomization
Prior or concurrent systemic treatment for SMM; a) bisphosphonates are permitted; b) treatment with corticosteroids is not permitted; c) radiotherapy is not permitted; d) prior treatment for smoldering multiple myeloma with chemotherapy agents approved for the treatment of multiple myeloma is not permitted
Refractory multiple myeloma defined as meeting or more of the following:
At least but no more than prior therapies for multiple myeloma
Symptomatic multiple myeloma or any evidence of CRAB criteria including the new criteria for overt myeloma; any prior therapy for active myeloma should also be excluded; prior therapy for smoldering myeloma is not an exclusion criterion; bisphosphonates are not excluded
New diagnosis of multiple myeloma with no prior history of treatment (exceptions include corticosteroids, bisphosphonates, single agent cyclophosphamide, =< days of the first cycle of a planned regimen)
Patient has exquisitely radiosensitive histology, such as multiple myeloma, lymphoma, leukemia, or seminoma
Histologic confirmation of multiple myeloma by the enrolling institution
Patients who have received =< cycle of therapy after most recent progression/relapse are eligible to enroll on study\r\n* Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with current or prior corticosteroids is permitted\r\n* Bisphosphonates are permitted\r\n* Concurrent or prior treatment with corticosteroids for indications other than multiple myeloma is permitted\r\n* Prior treatment with radiotherapy is permitted\r\n* Patients with measurable disease who received up to one cycle of any therapy within days with a washout period of weeks from last dose (on a trial or outside a trial) are eligible
Patients with a diagnosis of multiple myeloma (MM) not achieving a VGPR or better to the most recent therapy.
Patients receiving > cycle of prior treatment or concurrent systemic treatment for multiple myeloma\r\n* Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with current or prior corticosteroids is permitted\r\n* Bisphosphonates are permitted\r\n* Concurrent or prior treatment with corticosteroids for indications other than multiple myeloma is permitted\r\n* Prior treatment with radiotherapy is permitted\r\n* Prior treatment for smoldering myeloma is permitted with a washout period of weeks from last dose; smoldering patients previously treated with carfilzomib are excluded\r\n* Patients with measurable disease who received up to one cycle of any therapy within days with a washout period of weeks from last dose (on a trial or outside a trial) are eligible
Male or female patients years or older diagnosed with Multiple Myeloma according to standard criteria who have not received prior treatment
Prior treatment for multiple myeloma with either standard of care treatment or investigational regimen
Participants must have had a diagnosis of symptomatic multiple myeloma (MM), MM + amyloidosis, or POEMS (osteosclerotic myeloma: polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) requiring treatment; participants with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy; note that study participants do not need to have active disease at the time of study entry, as participants may have received up to months of prior chemotherapy, which might have induced a response
Symptomatic multiple myeloma;
Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinomas, germ cell tumors)
(Part ) Have received at least prior line of therapy for multiple myeloma
Recovered from the effects of any prior systemic therapy or radiotherapy for Multiple Myeloma
Having symptomatic multiple myeloma, defined by any of the following (if due to myeloma): lytic bone lesions, severe osteopenia (low bone density), pathologic fractures, hypercalcemia (too much calcium in the blood), kidney insufficiency; symptomatic hyperviscosity of the blood, or recurrent serious bacterial infections such as pneumonia
Patient must not have been previously treated with any prior systemic therapy for the treatment of active multiple myeloma\r\n* Prior treatment of hypercalcemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of mg of dexamethasone in a week period)\r\n* Bisphosphonates are permitted\r\n* Prior therapy for smoldering myeloma is permitted
Previously diagnosed with multiple myeloma.
Patients meeting the criteria for symptomatic multiple myeloma (MM):\r\n* Lytic lesions on skeletal survey or\r\n* Plasmacytoma\r\nPatients meeting International Myeloma Working Group definition of symptomatic myeloma with symptoms only related to associated amyloidosis who would otherwise only meet the criteria for smoldering MM are potentially eligible
Patients receiving > cycle of prior treatment or concurrent systemic treatment for multiple myeloma\r\n* Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with current or prior corticosteroids is permitted\r\n* Bisphosphonates are permitted\r\n* Concurrent or prior treatment with corticosteroids for indications other than multiple myeloma is permitted\r\n* Prior treatment with radiotherapy is permitted\r\n* Prior treatment for smoldering myeloma is permitted with a washout period of weeks from last dose; smoldering patients previously treated with carfilzomib are excluded\r\n* Patients with measurable disease who received up to one cycle of any therapy within days with a washout period of weeks from last dose (on a trial or outside a trial) are eligible
Patients may have received cycle of prior therapy with dexamethasone for multiple myeloma
Multiple myeloma\r\n* Relapse/progression after autologous HSCT\r\n* Plasma cell leukemia\r\n* Adverse cytogenetics: del(q) or q translocation
Meets diagnostic criteria for symptomatic multiple myeloma
Lesions due to hematologic malignancy (e.g. multiple myeloma at site of the index vertebra (e),
Patients with progressive or refractory plasma cell myeloma, as defined by International Myeloma Workshop Consensus Panel criteria
Diagnosed with previously treated multiple myeloma.
Treatment Group C (TGC): Multiple myeloma
Must have received at least one prior systemic therapy for the treatment of multiple myeloma
Melanoma, papillary thyroid cancer or hematological malignancies (with the exception of multiple myeloma)
Patients previously diagnosed with multiple myeloma
No more than six months worth of multiple myeloma chemotherapy is allowed (from the date of the start of the induction therapy)
Patients with confirmed multiple myeloma whose treatment history must include all of the following:
Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma, and multiple myeloma.
Patients with multiple myeloma (MM) diagnosed according to standard criteria or patients with a diagnosis of an advanced malignant solid tumor for which standard, curative, or life prolonging treatment does not exist or is no longer effective. Patients with multiple myeloma must have had at least prior therapy
No prior treatment for multiple myeloma
Multiple myeloma
Multiple myeloma with relapsing or progressing disease at study entry.
Patients must have evaluable multiple myeloma with, at least one of the following (assessed within days prior to randomization):
Multiple myeloma (MM)
Subjects with Multiple Myeloma (MM) and renal function fitting one of three categories:
Symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ damage diagnosed according to standard criteria
Prior systemic therapy for multiple myeloma, including investigational drugs (prior treatment with corticosteroids or localized radiation therapy dose not disqualify the patient)
Is diagnosed with symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ damage according to standard criteria
Has prior systemic therapy for multiple myeloma, including investigational drugs (prior treatment with corticosteroids or localized radiation therapy dose not disqualify the participantt)
Use of any anti-myeloma drug therapy within days of initiation of study drug treatment excluding corticosteroids if given for an indication other than myeloma; note: bisphosphonates are not considered anti-myeloma drugs
Symptomatic multiple myeloma
Prior treatment with at least one, but no more than three, regimens for multiple myeloma
Previously untreated, symptomatic multiple myeloma as defined by the criteria below:
A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.
Patients who have not received any chemotherapy treatment for multiple myeloma prior to being enrolled in the study
Patients who were receiving simvastatin (dose > mg/day) while receiving current chemotherapy regimen for multiple myeloma
Completion of last anti-myeloma therapy (if any) must occur at least days before conditioning
Patients may have had or more prior chemotherapy regimens for multiple myeloma but none within the preceding days
Histologies of myeloma or lymphoma
Documented evidence of multiple myeloma (per local assessment):
Multiple myeloma in CR/very good partial response (VGPR)
Prior treatment with a drug that targets BCMA on tumor cells or any other bi specific antibody construct or chimeric antigen receptor T cell (CAR-T) infusion for the treatment of multiple myeloma
Subject has aplastic anemia or multiple myeloma
Patients with the clinical diagnosis of multiple myeloma (MM) will be referred to MRI by hematologists/oncologists at New York University Medical Center (NYUMC) who care for these patients
Have history of paraproteinemias or multiple myeloma
NORMAL VOLUNTEERS: Have history of paraproteinemias or multiple myeloma
Has received previous myeloma-specific therapy.
Received at least prior treatment regimen or line of therapy for multiple myeloma
Previous treatments for multiple myeloma (MM) within weeks of initiation of study treatment
Hematologic malignancies or multiple myeloma.