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CAR T-cell Therapy

Ide-cel Combination Therapy for Multiple Myeloma (KarMMa-7 Trial)

Q: Are there any precedent studies related to CC-220?

<p>CC-220 was first researched at Manitoba Blood &#x26; Marrow <a href="https://www.withpower.com/clinical-trials/transplant">Transplant</a> Program CancerCare Manitoba in 2002. Since then, 1419 clinical trials on this subject have been completed and there are currently 619 studies taking place with a notable concentration of them located in Houston and <a href="https://www.withpower.com/clinical-trials/north-carolina">North carolina</a>.</p>

Phase 1 & 2

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has received at least 3 prior MM regimens for Arm A Cohort 1 and Arm B

Participant achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months after bb2121 infusion in the respective cohort

Awards & highlights

KarMMa-7 Trial Summary

This trial is testing the safety and efficacy of a new drug, bb2121, in combination with other therapies, in adult patients with relapsed or refractory multiple myeloma. There are three arms in the trial testing different combinations of drugs. The study will first determine the best dose of bb2121 (Phase 1), and then expand to testing the efficacy of the combinations in a larger group of patients (Phase 2).

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects aren't specified here, but generally for cancer trials like this they can include fatigue, nausea, immune system reactions, infusion-related reactions from the drug combinations being tested, as well as impacts on blood cell counts leading to increased infection risk.

KarMMa-7 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have undergone at least 3 treatments for multiple myeloma.

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I have responded positively to at least one prior treatment.

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

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I am fully active or can carry out light work.

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I've been treated with specific cancer drugs for at least 2 cycles.

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I have been treated with an immune system booster for at least 2 cycles.

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My cancer progressed within 6 months after my last treatment.

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I have undergone 1 to 3 treatments for multiple myeloma.

KarMMa-7 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months after bb2121 infusion in the respective cohort

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months after bb2121 infusion in the respective cohort

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months after bb2121 infusion in the respective cohort for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete Response Rate (CRR)_ Phase 2

Does Limiting Toxicity (DLT) rates _Phase 1

Secondary outcome measures

Duration of Response (DoR)

Feasibility of maintenance therapy in combination with bb2121

Incidence of Adverse Event (AEs)

+11 more

KarMMa-7 Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B- bb2121 in combination with BMS-986405 (JSMD194)Experimental Treatment2 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 Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC-220

2016

Completed Phase 2

~620

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

633 Previous Clinical Trials

127,730 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,551 Patients Enrolled for Multiple Myeloma

Gianfranco Pittari, Md, PhDStudy DirectorCelgene Corporation

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,501 Previous Clinical Trials

3,367,358 Total Patients Enrolled

71 Trials studying Multiple Myeloma

24,925 Patients Enrolled for Multiple Myeloma

Media Library

BB2121 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04855136 — Phase 1 & 2

Multiple Myeloma Research Study Groups: Arm A- bb2121 in combination with CC-220 (± low-dose dexamethasone), Arm B- bb2121 in combination with BMS-986405 (JSMD194)

Multiple Myeloma Clinical Trial 2023: BB2121 Highlights & Side Effects. Trial Name: NCT04855136 — Phase 1 & 2

BB2121 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04855136 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aim is the research team endeavoring to achieve with this medical experiment?

"Celgene, the study sponsor of this trial, has reported that their primary outcome to be monitored over a 24-month period is the Limiting Toxicity (DLT) rate in Phase 1. Additionally, they are also assessing secondary outcomes such as Cumulative incidence of maintenance therapy starting from bb2121 infusion with death being an alternate event, Pharmacokinetics Area under Curve for transgene levels within 28 days _Phase 1 and 2 , and lastly Pharmacokinetics - Time of Last measurable transgene level_Phase1 and 2 ."

Answered by AI

What medical conditions is CC-220 utilized to treat?

"Ocular ailments, ranging from ophthalmia to macular edema as well as branch retinal vein occlusion, can be treated with the drug CC-220."

Answered by AI

Are there any precedent studies related to CC-220?

"CC-220 was first researched at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba in 2002. Since then, 1419 clinical trials on this subject have been completed and there are currently 619 studies taking place with a notable concentration of them located in Houston and North carolina."

Answered by AI

Are any openings remaining for participants in this research?

"Affirmative. According to records found on clinicaltrials.gov, this trial began recruiting participants as of June 1st 2021 and is still currently seeking 415 patients across 22 centers."

Answered by AI

To what extent has recruitment for this clinical trial been successful?

"Affirmative. Information found on clinicaltrials.gov reveals that this research study, which was first made available on June 1st 2021, is currently recruiting participants. Approximately 415 patients will be sourced from 22 separate sites for the trial."

Answered by AI

How many centers are actively managing this experiment?

"This trial is being held at many medical institutions, including The University of Texas - MD Anderson Cancer Center in Houston, Duke University Medical Centre in Durham, and the University of Alabama Birmingham in Birmingham. Additionally, there are 20 other sites recruiting patients for this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma

2021. "Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04855136.

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