← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum 5 years after bb2121 infusion

Awards & highlights

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

Select...

I am 18 years old or older.

Select...

I have had 2 to 4 treatments for multiple myeloma.

Select...

I have been treated with DARA and drugs for immune and protein breakdown for 2 cycles.

Select...

I will not have unprotected sex during the study.

Select...

My last cancer treatment did not work.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

I have recovered from side effects of previous treatments, except for hair loss and mild nerve damage.

Select...

I have good veins for blood collection.

Select...

I am able to have children and have a negative pregnancy test.

Select...

I am using or willing to use birth control if I can have children.

Select...

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

Select...

I agree not to breastfeed while participating in the study.

Select...

I will not donate eggs or any tissues while in the trial.

Select...

I will not donate sperm or any tissues while in the trial.

KarMMa-3 Trial 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

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

2014

Completed Phase 3

~1860

Dexamethasone

2007

Completed Phase 4

~2590

Bortezomib

2005

Completed Phase 2

~1140

Ixazomib

2017

Completed Phase 4

~3370

Carfilzomib

2017

Completed Phase 3

~1440

Elotuzumab

2016

Completed Phase 3

~800

Lenalidomide

2005

Completed Phase 3

~1480

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,590 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,482 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,506 Previous Clinical Trials

3,369,149 Total Patients Enrolled

72 Trials studying Multiple Myeloma

24,906 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

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

2019. "Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03651128.

All > Multiple Myeloma > Velcade