bb2121 for Multiple Myeloma

(KarMMa-2 Trial)

Not currently recruiting at 42 trial locations
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BS
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Overseen ByFirst line of the email MUST contain the NCT# and Site #.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Celgene
Must be taking: Proteasome inhibitors, Immunomodulatory agents
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 trial tests a new treatment called bb2121 (also known as Idecabtagene vicleucel, Abecma, or ide-cel) for people with multiple myeloma, a type of blood cancer. The researchers aim to assess how well bb2121 works and its safety for those whose cancer has returned or hasn’t responded to other treatments. The trial includes different groups: those who have tried many treatments, those newly diagnosed, and those who have had specific past treatments like stem cell transplants. Suitable candidates for this trial are individuals with multiple myeloma who have experienced cancer recurrence or haven't succeeded with previous treatments and meet specific treatment history and response criteria. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot use any systemic anti-myeloma drug therapy within 14 days before certain procedures in the trial. It's best to discuss your current medications with the trial team.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have used any investigational agents or systemic anti-myeloma drug therapy within 14 days before certain trial procedures.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bb2121, also known as idecabtagene vicleucel, was tested for safety in people with multiple myeloma. In earlier studies, many patients tolerated the treatment well, although some side effects occurred. Common side effects included low blood cell counts and tiredness. More serious side effects, such as infections or cytokine release syndrome (a reaction that can cause fever and low blood pressure), were less common but did occur.

The evidence indicates that while most patients experienced some side effects, many found the treatment manageable. Potential participants should consider these risks and discuss them with their healthcare provider before joining the trial.12345

Why are researchers excited about this trial's treatment?

Researchers are excited about bb2121 for multiple myeloma because it offers a novel approach through CAR T-cell therapy. Unlike standard treatments like chemotherapy and stem cell transplants, bb2121 modifies a patient's own T-cells to attack cancer cells specifically, targeting the BCMA protein found on myeloma cells. This personalized treatment has the potential to deliver more effective and long-lasting results with fewer side effects. Additionally, certain arms of the trial explore the combination of bb2121 with other agents like lenalidomide and talquetamab, which could enhance its effectiveness and offer new hope for patients with different stages and responses to the disease.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research shows that bb2121, also known as ide-cel, is a promising treatment for multiple myeloma, particularly for patients who have not responded to other treatments. In this trial, participants will join different cohorts to evaluate bb2121 in various contexts, such as with or without autologous stem cell transplantation, in relapsed and refractory cases, and with lenalidomide maintenance. Studies have shown a high overall response rate. Specifically, one study reported that 89% of patients responded to the treatment. In another study, 84% of patients had a positive response, with more than half showing no signs of cancer afterward. These results suggest that bb2121 could be very effective for treating relapsed or hard-to-treat multiple myeloma, offering hope to patients with limited options.12678

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Multiple Myeloma that's come back or didn't respond to treatment, including those who've had a stem cell transplant. It's not for those who've recently used investigational drugs, have certain medical conditions like organ failure or uncontrolled infections, are pregnant or breastfeeding, or have a history of blood clots.

Inclusion Criteria

I have recovered from side effects of previous treatments, except for hair loss and mild nerve pain.
Participants need to meet specific requirements for the type of multiple myeloma they have.
My disease can be measured by tests.
See 1 more

Exclusion Criteria

I haven't had certain treatments in the 2 weeks before my leukapheresis or giving consent.
I do not have a history of severe illnesses, infections, or other health conditions listed.
Subject used any investigational agents within 14 days prior to leukapheresis or, for Cohort 3, within 14 days prior to consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Bridging Therapy

Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured for cohorts 1, 2a, and 2b

Variable

Treatment

Participants receive bb2121 autologous CAR T cells infusion after lymphodepleting chemotherapy

Single infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • bb2121
Trial Overview The study tests bb2121 and Lenalidomide in different groups: one with relapsed/refractory myeloma after multiple treatments; others with early relapse post-transplant; and some with inadequate response to initial transplant therapy. The goal is to see how well these treatments work and their safety.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Cohort 3: BB2121 with lenalidomide maintenance in newly diagnosed multiple myelomaExperimental Treatment2 Interventions
Group II: Cohort 2c: BB2121 in multiple myeloma participants with inadequate response post ASCTExperimental Treatment1 Intervention
Group III: Cohort 2b: BB2121 in multiple myeloma without Autologous stem cell transplantation participantsExperimental Treatment1 Intervention
Group IV: Cohort 2a: BB2121 in multiple myeloma with Autologous stem cell transplantation participantsExperimental Treatment1 Intervention
Group V: Cohort 1b: BB2121 with talquetamab in relapsed and refractory multiple myeloma participantsExperimental Treatment2 Interventions
Group VI: Cohort 1: BB2121 in relapsed and refractory multiple myeloma participantsExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Abecma for:
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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+
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>- **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

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]
In a phase 3 trial with 386 patients suffering from relapsed and refractory multiple myeloma, idecabtagene vicleucel (ide-cel) significantly improved progression-free survival (13.3 months) compared to standard treatments (4.4 months), indicating its efficacy in this challenging patient population.
The treatment with ide-cel resulted in a 71% overall response rate, including a 39% complete response rate, although it was associated with high rates of adverse events (93% grade 3 or 4), including cytokine release syndrome in 88% of patients.
Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma.Rodriguez-Otero, P., Ailawadhi, S., Arnulf, B., et al.[2023]
Idecabtagene vicleucel, a CAR T-cell therapy targeting BCMA, showed a 72% overall response rate and a 28% complete response rate in 100 adult patients with relapsed/refractory multiple myeloma after a median follow-up of 10.7 months.
While the therapy demonstrated significant efficacy, serious adverse reactions were reported in 67% of patients, including cytokine release syndrome and neurologic toxicities, necessitating a Risk Evaluation and Mitigation Strategy.
FDA Approval Summary: Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma.Sharma, P., Kanapuru, B., George, B., et al.[2023]

Citations

Idecabtagene Vicleucel in Relapsed and Refractory ...Idecabtagene vicleucel (ide-cel, also called bb2121) showed promising efficacy in a phase 1 study involving patients with relapsed or refractory myeloma.
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36690910/
Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121 ...Results: Nine patients were treated with ide-cel. The overall response rate was 89% (median follow-up, 12.9 months). The best overall response was stringent ...
ABECMA® Clinical Trial ResultsSee ABECMA® (idecabtagene vicleucel) clinical trial results for adults with relapsed/refractory multiple myeloma and how they responded to treatment.
Ide-Cel Effective, Safe for Treatment of Multiple Myeloma in ...Patient outcomes were similar to the ones reported in the phase 2 KarMMa trial; researchers reported an overall response rate of 73%, a ...
Outcomes of ide-cel in patients with relapsed/refractory ...The median follow-up was 11.4 months. The objective response rate was 84%; sCR was seen in 56% of patients, VGPR in 16%, PR in 12%, and PD in 16 ...
Efficacy and Safety of Idecabtagene Vicleucel (ide-cel) in ...In cohort 2c, with a median follow-up of 27.9 months, ide-cel demonstrated deep and durable responses; complete response (CR) rate was 74.2% ( ...
Abecma (idecabtagene vicleucel) Reduced the Risk ...Abecma (idecabtagene vicleucel) Reduced the Risk of Disease Progression or Death by 51% Versus Standard Regimens in Earlier Lines of Therapy ...
NCT03361748 | Efficacy and Safety Study of bb2121 in ...This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple ...
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