← Back to Search

CAR T-cell Therapy

CAR T Cell Therapy for Multiple Myeloma (KarMMa Trial)

Phase 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
Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Must be refractory to the last treatment regimen.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum of 24 months post-bb2121 infusion
Awards & highlights

KarMMa Trial Summary

This trial is testing a new cancer treatment involving CAR T cells. Lymphodepleting therapy will be used prior to infusion of the CAR T cells.

Who is the study for?
This trial is for adults over 18 with multiple myeloma that's come back or hasn't responded to treatment. They must have tried at least three different treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Participants need measurable levels of the disease in their blood or urine and should be fairly healthy otherwise (ECOG status 0 or 1). Pregnant women, those with CNS involvement by myeloma, certain infections like HIV/HBV/HCV, severe heart conditions, or previous gene/cellular therapies can't join.Check my eligibility
What is being tested?
The study tests bb2121—a CAR T-cell therapy—on people whose multiple myeloma has relapsed or is refractory. Patients will undergo a leukapheresis procedure to collect cells needed to create bb2121 which are then infused back after receiving drugs (fludarabine and cyclophosphamide) that prepare their immune system.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever and chills; low blood cell counts leading to increased infection risk; fatigue; nausea; headaches; shortness of breath; potential allergic reactions to the drug components used during treatment.

KarMMa Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You did not respond well to the last treatment you received.
Select...
You have been diagnosed with multiple myeloma and it is written in your medical records.
Select...
You must have tried at least 3 different treatments for multiple myeloma. If you had a stem cell transplant and/or maintenance therapy after your initial treatment, it still counts as one regimen.
Select...
You must have tried at least two rounds of treatment for each plan, unless your condition got worse as the best response to the plan.
Select...
You must have already taken certain types of medications called proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody.
Select...
You are in good enough health to carry out your usual activities without limitations (ECOG performance status 0 or 1).
Select...
You must have recovered from any side effects of previous treatments, except for hair loss and mild nerve problems.

KarMMa Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum of 24 months post-bb2121 infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of 24 months post-bb2121 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Adverse Events (AEs)
Complete Response (CR) Rate
Duration of Response
+12 more

KarMMa Trial Design

1Treatment groups
Experimental Treatment
Group I: Administration of bb2121Experimental Treatment1 Intervention
bb2121 autologous CAR T cells will be infused at a dose ranging from 15 - 450 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bb2121
2017
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
632 Previous Clinical Trials
127,771 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,714 Patients Enrolled for Multiple Myeloma
Kristen HegeStudy DirectorCelgene
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Multiple Myeloma
50 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,499 Previous Clinical Trials
3,367,104 Total Patients Enrolled
71 Trials studying Multiple Myeloma
25,088 Patients Enrolled for Multiple Myeloma

Media Library

bb2121 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03361748 — Phase 2
Multiple Myeloma Research Study Groups: Administration of bb2121
Multiple Myeloma Clinical Trial 2023: bb2121 Highlights & Side Effects. Trial Name: NCT03361748 — Phase 2
bb2121 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03361748 — Phase 2

Frequently Asked Questions

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

Has the FDA authorized bb2121 for use?

"With the data from phase 2 trials, our team evaluated bb2121's safety to be a score of two. Despite this assessment, there is currently no clinical evidence proving efficacy."

Answered by AI

What therapeutic purpose does bb2121 usually serve?

"bb2121 has been shown to be efficacious in the management of refractory multiple myeloma, as well as patients who previously received proteasome inhibitor or anti-cd38 monoclonal antibody treatments."

Answered by AI

What is the geographical distribution of this research program?

"This research is taking place at Local Institution - 101 in Nashville, Tennessee; University of Texas Southwestern Medical Center in Dallas, Texas; and Local Institution - 108 in San Francisco, California. Additionally, 20 other clinical trial sites are being utilized for this investigation."

Answered by AI

Is this particular experiment currently enrolling participants?

"This research project is not currently taking in candidates. It was initially published on December 13th of 2017 and the details were most recently revised on July 18th 2022. At present, there are 807 studies for multiple myeloma that accept participants and 8 trials for bb2121 still recruiting patients."

Answered by AI

Is this an innovative research project?

"Currently, 8 trials for bb2121 are ongoing in 54 cities and 13 nations. Celgene initiated the initial pilot study back in 2015 with 67 participants that successfully completed Phase 1 drug approval. To date, no further studies have been concluded following this trial's completion five years ago."

Answered by AI

Are there extant studies of bb2121's effectiveness?

"Initially investigated in 2015 by Beth Israel Deaconess Medical Center, bb2121 has yet to be completed for a full trial. Currently, 8 active clinical experiments are taking place with some of them based out Nashville, Tennessee."

Answered by AI

What is the projected enrollment number for this research project?

"Patient recruitment for this trial has concluded. Initially posted on December 13th 2017, the study was last modified July 18th 2022. For individuals searching for other trials to join, there are presently 807 multiple myeloma clinical studies and 8 bb2121 related investigations actively recruiting patients."

Answered by AI
Recent research and studies
~21 spots leftby Mar 2025