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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 received at least 2 but no greater than 4 prior MM regimens

Must not have

Subject has inadequate pulmonary function defined as oxygen saturation (SaO2) < 92% on room air

Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum 5 years after bb2121 infusion

Awards & highlights

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.

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 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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I will not have unprotected sex during the study.

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My last cancer treatment did not work.

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

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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 donate sperm or any tissues while in the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My oxygen levels are below 92% without extra oxygen.

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I have lung problems and blood clotting issues.

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I have an untreated infection.

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I cannot or do not want to follow the required blood clot prevention plan.

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I cannot tolerate bortezomib or have widespread lung and heart lining disease.

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My multiple myeloma does not produce detectable levels of M protein.

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I have or had plasma cell leukemia, Waldenstrom's, POEMS syndrome, or amyloidosis.

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I have COPD with less than half the normal lung function.

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I have not had a stem cell transplant, gene therapy, cellular therapy, or BCMA targeted therapy for cancer.

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I had a stem cell transplant using my own cells within the last 12 weeks.

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My heart's pumping ability is below normal.

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I have a significant brain or nervous system condition.

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I am currently on long-term immunosuppressants.

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I am positive for HIV, hepatitis B, or active hepatitis A or C.

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I am not allergic to specific cancer drugs like DARA or thalidomide.

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I am currently pregnant, nursing, or breastfeeding.

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My myeloma has spread to my brain or spinal cord.

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I am not allergic to any components in the bb2121 treatment or related medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ minimum 5 years after bb2121 infusion

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

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

2014

Completed Phase 3

~2000

Dexamethasone

2007

Completed Phase 4

~2640

Bortezomib

2005

Completed Phase 2

~1060

Ixazomib

2017

Completed Phase 4

~3370

Carfilzomib

2017

Completed Phase 3

~1310

Elotuzumab

2016

Completed Phase 3

~800

Lenalidomide

2005

Completed Phase 3

~1340

0 / 32Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

643 Previous Clinical Trials

129,731 Total Patients Enrolled

144 Trials studying Multiple Myeloma

41,252 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,536 Previous Clinical Trials

3,375,426 Total Patients Enrolled

74 Trials studying Multiple Myeloma

25,223 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

~128 spots leftby Apr 2027

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