Ide-cel Combination Therapy for Multiple Myeloma
(KarMMa-7 Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
This trial is for adults with relapsed or refractory multiple myeloma (R/RMM) who've had at least one prior treatment. They should have shown some response to previous treatments and currently show disease progression. Good physical condition (ECOG 0-1) is required, but those with certain blood conditions, severe liver issues, recent bleeding events or specific past treatments like gene therapy are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Finding (Phase 1)
Participants receive bb2121 in combination with other therapies to determine the recommended Phase 2 dose
Dose Expansion (Phase 2)
Participants receive bb2121 in combination with other therapies to evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BB2121
- BMS-986405
- Bortezomib
- CC-220
- Dexamethasone
- Pomalidomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Celgene
Lead Sponsor
Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania