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CAR T-cell Therapy

bb2121 for Multiple Myeloma (KarMMa-3 Trial)

Phase 3
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)
Subject has documented diagnosis of MM and measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum 5 years after bb2121 infusion
Awards & highlights
Pivotal Trial
No Placebo-Only Group

KarMMa-3 Trial Summary

This trial is comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma.

Who is the study for?
Adults with relapsed and refractory multiple myeloma who have had 2-4 prior treatments, including Daratumumab, a proteasome inhibitor, and an immunomodulatory drug. They must be in good physical condition (ECOG status of 0 or 1), not pregnant or breastfeeding, willing to use contraception, and able to follow the study requirements for up to 15 years.Check my eligibility
What is being tested?
The trial is testing bb2121 against standard regimens like Pomalidomide/Dexamethasone (DPd) and others. It's randomized: about two-thirds will receive bb2121; one-third will get standard treatment. The goal is to compare effectiveness and safety between these options.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever or fatigue, blood cell count changes leading to increased infection risk or bleeding problems, allergic reactions specific to the drugs used in the trial, nerve damage causing numbness or pain.

KarMMa-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with multiple myeloma and it can be measured.
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I have had 2 to 4 treatments for multiple myeloma.
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I have been treated with DARA and drugs for immune and protein breakdown for 2 cycles.
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My last cancer treatment did not work.
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I have seen improvement in my condition after at least one treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have recovered from side effects of previous treatments, except for hair loss and mild nerve damage.
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I have good veins for blood collection.
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I am able to have children and have a negative pregnancy test.
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I am using or willing to use birth control if I can have children.
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I agree not to breastfeed while participating in the study.
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I will not donate eggs or any tissues while in the trial.
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I will not have unprotected sex during the study.
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I will not donate sperm or any tissues while in the trial.
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I am eligible for one of the five standard treatment options.

KarMMa-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum 5 years after bb2121 infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum 5 years after 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
Progression-free Survival (PFS)
Secondary outcome measures
Adverse Events (AEs)
Complete Response (CR) Rate
Duration of Response (DOR)
+15 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

KarMMa-3 Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B- standard regimens as per Investigator's discretionExperimental Treatment8 Interventions
The participants will receive one of following regimens dependent on the subject's most recent anti-myeloma treatment regimen: Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (dex) (DPd) OR DARA in combination with bortezomib (BTZ) and low-dose dex (DVd) OR Ixazomib (IXA) in combination with lenalidomide (LEN) and low-dose dex (IRd) OR Carfilzomib (CFZ) in combination with low-dose dexamethasone (Kd) OR Elotuzumab (ELO) in combination with POM and low-dose dexamethasone (EPd)
Group II: Arm A - Administration of bb2121Experimental Treatment1 Intervention
bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
bb2121
2017
Completed Phase 2
~230
Daratumumab
2016
Completed Phase 3
~1750
Dexamethasone
2007
Completed Phase 4
~2590
Bortezomib
2005
Completed Phase 2
~1140
Ixazomib
2017
Completed Phase 4
~3400
Carfilzomib
2017
Completed Phase 3
~1410
Elotuzumab
2016
Completed Phase 3
~800
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
632 Previous Clinical Trials
127,646 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,481 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,495 Previous Clinical Trials
3,365,788 Total Patients Enrolled
70 Trials studying Multiple Myeloma
24,706 Patients Enrolled for Multiple Myeloma
Steven Novick, MDStudy DirectorCelgene

Media Library

bb2121 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03651128 — Phase 3
Multiple Myeloma Research Study Groups: Arm A - Administration of bb2121, Arm B- standard regimens as per Investigator's discretion
Multiple Myeloma Clinical Trial 2023: bb2121 Highlights & Side Effects. Trial Name: NCT03651128 — Phase 3
bb2121 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03651128 — Phase 3

Frequently Asked Questions

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

Are there any available positions for participants in this research?

"That is correct, the information available on clinicaltrials.gov does show that this study is actively recruiting patients. The trial was originally posted on April 16th, 2019 and was last edited on October 4th, 2020. The researchers conducting this study are looking for 381 patients at 1 site."

Answered by AI

Does bb2121 have the FDA's green light for usage?

"There is already clinical evidence affirming bb2121's safety, thus it received a 3."

Answered by AI

How many individuals are enrolled in this experiment?

"Yes, the trial is presently open for recruitment according to the information available on clinicaltrials.gov. This particular study was first posted on April 16th, 2019 and was most recently updated on October 4th, 2020. The research team is looking to enroll 381 participants at a single site."

Answered by AI

What are the primary indications for bb2121?

"ophthalmia, sympathetic is most effectively treated with bb2121. However, this medication can also be helpful for managing branch retinal vein occlusion, macular edema, and at least two different types of prior systemic chemotherapy regimens."

Answered by AI
~148 spots leftby Apr 2027