for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around



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 (± low-dose dexamethasone)
  • Arm B will test bb2121 in combination with BMS-986405 (JSMD194)

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.

Official Title

An Exploratory Phase 1/2 Trial to Determine Recommended Phase 2 Dose (RP2D), Safety and Preliminary Efficacy of bb2121 (Ide-cel) Combinations in Subjects With Relapsed/Refractory Multiple Myeloma (KarMMa-7)


Multiple Myeloma, Relapsed/Refractory Multiple Myeloma, BB2121, ide-cel, CC-220, JSMD194, BMS-986405, DPd, PVd, CAR T, KarMMa-7, Phase I, Phase II, DARA, POM, BTZ, Plasma Cell Neoplasms, Idecabtagene vicleucel


You can join if…

Open to people ages 18 years and up

Participants must satisfy the following criteria to be enrolled in the study:

  • Participant has documented diagnosis of MM and measurable disease, defined as:
    1. M-protein (serum protein electrophoresis [sPEP ≥ 0.5 g/dL] or urine protein electrophoresis [uPEP]): uPEP ≥ 200 mg/24 hours and/or
    2. Light chain MM without measurable disease in the serum or urine: Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Participant has received:
    1. at least 3 prior MM regimens for Arm A Cohort 1 and Arm B
    2. 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.

You CAN'T join if...

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:
    1. ANC and Platelets count as reported below
    2. Hemoglobin < 8 g/dL (< 4.9 mmol/L) (transfusion is not permitted within 21 days of screening)
    3. Creatinine clearance (CrCl) as reported below
    4. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
    5. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 ×upper limit of normal (ULN)
    6. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for participants with documented Gilbert's syndrome
    7. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) 1.5 × ULN, or history of Grade ≥ 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 (± 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.


  • Local Institution - 113
    San Francisco California 94143 United States
  • Local Institution - 107
    Houston Texas 77030 United States


in progress, not accepting new patients
Start Date
Completion Date
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls
Phase 1/2 Multiple Myeloma Research Study
Study Type
Expecting 312 study participants
Last Updated