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Ide-cel Combination Therapy for Multiple Myeloma (KarMMa-7 Trial)
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).
KarMMa-7 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowKarMMa-7 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.KarMMa-7 Trial Design
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Who is running the clinical trial?
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- I have undergone at least 3 treatments for multiple myeloma.I have responded positively to at least one prior treatment.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.I have been diagnosed with multiple myeloma and it can be measured.I am fully active or can carry out light work.I've been treated with specific cancer drugs for at least 2 cycles.I have been treated with an immune system booster for at least 2 cycles.My cancer progressed within 6 months after my last treatment.I have undergone 1 to 3 treatments for multiple myeloma.
- Group 1: Arm A- bb2121 in combination with CC-220 (± low-dose dexamethasone)
- Group 2: Arm B- bb2121 in combination with BMS-986405 (JSMD194)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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 ."
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."
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."
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."
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."
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."
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