Ide-cel Combination Therapy for Multiple Myeloma

(KarMMa-7 Trial)

Recruiting at 41 trial locations

Overseen By First line of the email MUST contain NCT # and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Celgene

Must be taking: Immunomodulatory agents

Must not be taking: Anticoagulants

Disqualifiers: Plasma cell leukemia, Amyloidosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

21 Participants Needed

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

I have undergone at least 3 treatments for multiple myeloma.

I have responded positively to at least one prior treatment.

I have been diagnosed with multiple myeloma and it can be measured.

Exclusion Criteria

I have a specific blood cancer type, not the common multiple myeloma.

If you have any of the following issues in your blood, kidney function, liver function, or clotting, or if you have certain lung or previous treatment problems, you may not be able to participate in this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding (Phase 1)

Participants receive bb2121 in combination with other therapies to determine the recommended Phase 2 dose

Up to 28 days

Multiple visits for dose limiting toxicity evaluation

Dose Expansion (Phase 2)

Participants receive bb2121 in combination with other therapies to evaluate safety and efficacy

Up to 24 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

Treatment Details

Interventions

• BB2121
• BMS-986405
• Bortezomib
• CC-220
• Dexamethasone
• Pomalidomide

Trial Overview The study tests bb2121 combined with other drugs in two arms: Arm A pairs it with CC-220 (with/without dexamethasone), while Arm B uses BMS-986405. It's a phase 1/2 trial aiming to find the right doses and expand testing based on safety and effectiveness results from earlier phases.

Participant Groups

Group I: Arm B- bb2121 in combination with BMS-986405 (JSMD194) Experimental Treatment 2 Interventions

* bb2121 will be administered at a target dose of 450 x 10\^6 CAR+T cells. The combination agent will be administered during Month 1 starting from the day of bb2121 infusion * Enrollment is closed for this Arm

Group II: Arm A- bb2121 in combination with CC-220 (± low-dose dexamethasone) Experimental Treatment 2 Interventions

bb2121 will be administered at a target dose of 450 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/ or schedules, depending on dose limiting toxicity (DLT) evaluation.

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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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