381 Participants Needed

bb2121 for Multiple Myeloma

(KarMMa-3 Trial)

Recruiting at 109 trial locations
AD
Rs
Fl
BS
Overseen ByBMS Study Connect Contact Center www.BMSStudyConnect.com
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Celgene
Must be taking: Proteasome inhibitors, Immunomodulatory compounds
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, it mentions that ongoing treatment with certain chronic medications, like immunosuppressants, may not be allowed. It's best to discuss your specific medications with the trial team.

Is idecabtagene vicleucel (bb2121) safe for humans?

Idecabtagene vicleucel (bb2121) has been studied for safety in patients with multiple myeloma. Serious side effects occurred in 67% of patients, including cytokine release syndrome (a severe immune reaction) and neurologic toxicities in 9% and 4% of patients, respectively. Some patients also experienced a condition called hemophagocytic lymphohistiocytosis/macrophage activation syndrome, with two fatalities reported.12345

What makes the treatment ide-cel unique for multiple myeloma?

Idecabtagene vicleucel (ide-cel) is unique because it is a CAR T-cell therapy that targets a specific protein called B-cell maturation antigen (BCMA) on cancer cells, offering a new option for patients with multiple myeloma who have not responded to other treatments. This therapy uses the patient's own immune cells, which are modified to better recognize and attack the cancer cells, providing deep and durable responses.13678

What data supports the effectiveness of the treatment idecabtagene vicleucel (ide-cel) for multiple myeloma?

Research shows that idecabtagene vicleucel (ide-cel) improves response rates, progression-free survival, and overall survival in patients with relapsed and refractory multiple myeloma compared to conventional care. It has been approved by the FDA and offers hope for more durable remissions and better quality of life for patients who have limited treatment options.156910

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had 2 to 4 treatments for multiple myeloma.
I have been treated with DARA and drugs for immune and protein breakdown for 2 cycles.
I have seen improvement in my condition after at least one treatment.
See 15 more

Exclusion Criteria

I haven't received any new treatments in the last 2 weeks.
Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
My oxygen levels are below 92% without extra oxygen.
See 24 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either bb2121 CAR T cells or standard regimens based on randomization

6-8 weeks
Multiple visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Minimum of 5 years
Regular visits for monitoring and assessments

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • bb2121
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm B- standard regimens as per Investigator's discretionExperimental Treatment8 Interventions
Group II: Arm A - Administration of bb2121Experimental Treatment1 Intervention

bb2121 is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Abecma for:
🇪🇺
Approved in European Union as Abecma for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials
649
Recruited
130,000+
Top Products
>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.
Jay Backstrom profile image

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles profile image

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Published Research Related to This Trial

In a phase 2 study involving 140 patients with relapsed and refractory multiple myeloma, idecabtagene vicleucel (ide-cel) demonstrated a 73% overall response rate, with 33% achieving a complete response or better after treatment.
While ide-cel showed significant efficacy, it also resulted in high rates of toxic effects, including severe neutropenia (91%) and cytokine release syndrome (84%), highlighting the need for careful monitoring during treatment.
Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma.Munshi, NC., Anderson, LD., Shah, N., et al.[2021]
In a study of 52 patients treated with idecabtagene vicleucel (ide-cel) for relapsed/refractory multiple myeloma, 65% experienced grade ≥ 3 cytopenias by day 30, indicating significant blood cell reductions, which required interventions like G-CSF and transfusions for many patients.
Infections were reported in 54% of patients, with 23% being severe; early infections were mostly bacterial, while later infections included both bacterial and viral types, highlighting the need for careful monitoring and management of infections post-treatment.
Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma.Logue, JM., Peres, LC., Hashmi, H., et al.[2022]
Patients with multiple myeloma who do not respond to existing therapies have limited survival, but new treatments like CAR T-lymphocytes, bispecific antibodies, and antibody-drug conjugates are showing promise in early trials.
Idecabtagene vicleucel (ide cel) and belantamab mafodotin (belamaf) have been approved for use in relapsed/refractory multiple myeloma based on positive results from phase 2 studies, indicating their potential effectiveness in this challenging patient population.
Chimeric antigen receptor T-cells, bispecific antibodies, and antibody-drug conjugates for multiple myeloma: An update.Lakshman, A., Kumar, SK.[2022]

Citations

Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. [2021]
Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma. [2022]
Chimeric antigen receptor T-cells, bispecific antibodies, and antibody-drug conjugates for multiple myeloma: An update. [2022]
Indirect treatment comparison of idecabtagene vicleucel versus conventional care in triple-class exposed multiple myeloma. [2022]
Idecabtagene vicleucel (ide-cel) CAR T-cell therapy for relapsed and refractory multiple myeloma. [2022]
Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial. [2023]
Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma: Real-World Experience From the Myeloma CAR T Consortium. [2023]
FDA Approval Summary: Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma. [2023]
Idecabtagene vicleucel for relapsed/refractory multiple myeloma: a review of recent advances. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security