Status:
TERMINATED
Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma
Lead Sponsor:
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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 \[sPEP ≥ 0.5 g/dL\] or urine protein electrophoresis \[uPEP\]): uPEP ≥ 200 mg/24 hours and/or
- 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:
- 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.
Exclusion
- 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 ×upper limit of normal (ULN)
- Serum total bilirubin \> 1.5 × 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 × 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04855136
Start Date
June 1 2021
End Date
April 25 2025
Last Update
September 11 2025
Active Locations (17)
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1
Local Institution - 117
Birmingham, Alabama, United States, 10016
2
Local Institution - 113
San Francisco, California, United States, 94143
3
Local Institution - 101
Jacksonville, Florida, United States, 32224-1865
4
Local Institution - 104
Atlanta, Georgia, United States, 30322