Multiple Myeloma Clinical Trial
Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma
This is a global, open-label, multi-arm, multi-cohort, multi-center, phase 1/2 study to determine the safety, tolerability, efficacy, PK of bb2121 in combination with other therapies in adult subjects with R/RMM.
The following combinations will be
Arm A will test bb2121 in combination with CC-220 (Â± low-dose dexamethasone)
Arm B will test bb2121 in combination with BMS-986405 (JSMD194)
Arm C will test bb2121 in combination with one of the following standard triplet regimens: 1) Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (DPd); 2) Pomalidomide (POM) in combination with bortezomib (BTZ) and low-dose dexamethasone (PVd)
Combination agents being tested may be administered before, concurrently with and/or following (ie, maintenance) bb2121 infusion.
The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms.
Participants must satisfy the following criteria to be enrolled in the study:
Participant has documented diagnosis of MM and measurable disease, defined as:
M-protein (serum protein electrophoresis [sPEP â‰¥ 0.5 g/dL] or urine protein electrophoresis [uPEP]): uPEP â‰¥ 200 mg/24 hours and/or
Light chain MM without measurable disease in the serum or urine: Serum immunoglobulin free light chain â‰¥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
Participant has received:
at least 3 prior MM regimens for Arm A Cohort 1 and Arm B
at least 1 but no greater than 3 prior MM regimens for Arm A Cohort 2
Arm A Cohort 1 and Arm B: Participant has received prior treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody-containing regimen for at least 2 consecutive cycles.
Arm A Cohort 2: Participant has received prior treatment with an immunomodulatory agent for at least 2 consecutive cycles.
Evidence of PD during or within 6 months (measured from the last dose of any drug within the regimen) of completing treatment with the last antimyeloma regimen before study entry.
Participant achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
The presence of any of the following will exclude a participant from enrollment:
Participant has non-secretory MM or has history of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
Participant has any of the following laboratory abnormalities:
ANC and Platelets count as reported below
Hemoglobin < 8 g/dL (< 4.9 mmol/L) (transfusion is not permitted within 21 days of screening)
Creatinine clearance (CrCl) as reported below
Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 Ã—upper limit of normal (ULN)
Serum total bilirubin > 1.5 Ã— ULN or > 3.0 mg/dL for participants with documented Gilbert's syndrome
International normalized ratio (INR) or activated partial thromboplastin time (aPTT) 1.5 Ã— ULN, or history of Grade â‰¥ 2 hemorrhage within 30 days, or participant requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)
Participant has inadequate pulmonary function defined as oxygen saturation (SaO2) < 92% on room air.
Participant has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal.
Prior exposure to CC-220 (Â± low-dose dexamethasone) as part of their most recent antimyeloma treatment regimen (Arm A).
Prior exposure to BMS-986405 (JSMD194) (Arm B).
Previous history of an allogeneic hematopoietic stem cell transplantation, treatment with any gene therapy-based therapeutic for cancer, investigational cellular therapy for cancer or BCMA targeted therapy.
Treatment Arm A Cohort 1 and Arm B: participant has received autologous stem cell transplantation (ASCT) within 12 weeks prior to leukapheresis.
Treatment Arm A Cohort 2: participant has received autologous stem cell transplantation (ASCT) within 12 months prior to leukapheresis.
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There are 16 Locations for this study
Birmingham Alabama, 10016, United States
San Francisco California, 94143, United States
Jacksonville Florida, 32224, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60611, United States
Boston Massachusetts, 02117, United States
Boston Massachusetts, 02215, United States
Hackensack New Jersey, 07601, United States
New York New York, 10032, United States
Charlotte North Carolina, 28204, United States
Philadelphia Pennsylvania, 19107, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Pamplona , 31008, Spain
Salamanca , 37007, Spain
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