Phase 2 Clinical Trial Studying the Safety and Efficacy of bb2121 in Participants with Relapsed and Refractory Multiple Myeloma or Clinical High-Risk Multiple Myeloma KARMMA-2
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What's the purpose of this trial?

The goal of this clinical trial is to learn more about the safety and effectiveness of investigational drug bb2121 in combination with lenalidomide maintenance when given to participants with relapsed and refractory or high-risk multiple myeloma. 

This trial is currently open and accepting patients.

What will happen during the trial?

This trial is organized into five main groups, or cohorts. Depending on when their myeloma was diagnosed, and the type and quantity of treatment previously received, participants will be assigned to one of the cohorts. Cohorts 1 and 3 are accepting patients. 

Participants in all cohorts are planned to receive bb2121 alone or bb2121 in combination with lenalidomide. The study can be broken down into a few different parts. 

Before bb2121 administration - During this part of the trial, participants will be screened for eligibility, undergo a collection of their T cells (leukapheresis) to make into investigational drug bb2121 and undergo other evaluations before the treatment part. Depending on the cohort they are placed in, participants may receive Lenalidomide or another approved treatment as anti-myeloma therapy while waiting for their T cells to be processed. 

bb2121 administration - During this part of the trial, participants will receive lymphodepleting chemotherapy and investigational drug bb2121. The lymphodepleting chemotherapy is used to remove some immune cells, making space for the investigational bb2121 T cells to grow in the body, and to increase the chances of the body’s ability to accept the investigational bb2121 T cells. When receiving investigational drug bb2121, participants will be hospitalized for approximately 14 days so that the study doctors can monitor closely for side effects. 

After bb2121 administration - Once discharged from the hospital, participants will need to stay within a 30 minute drive from the treating hospital and have a dedicated caregiver staying with them for the remainder of the 30 days following investigational drug bb2121 treatment. Participants will need to visit the study site for follow-up monthly for the first 6 months, then every 3 months for the first two years. The study doctor may prescribe a maintenance anti-myeloma therapy Lenalidomide during this time.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

  • meet prior line of therapy criteria. 
    • Participants in cohort 1 must have had 3 or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and an anti-CD38 antibody.
    • Participants in cohort 3 must have previously had an autologous stem cell transplant, including a proteasome inhibitor and immunomodulatory drug induction.
    • do not have central nervous system involvement of your myeloma.
    • do not have nonsecretory multiple myeloma.
    • have adequate bone marrow, cardiac, kidney, and lung function as described in the trial criteria. 
    • Suboptimal response to autologous stem cell transplant.

Additional eligibility criteria apply and can be explained by the study doctor. 

Additional Trial Information

Phase 2

Enrollment: 265 patients (estimated)

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Published Results

KarMMa-2 Cohort 2a: Efficacy and Safety of Idecabtagene Vicleucel in Clinical High-Risk Multiple Myeloma Patients with Early Relapse after Frontline Autologous Stem Cell Transplantation

July 05, 2024

Ide-cel was successfully manufactured and infused in 37/39 pts. Median age was 57 y; median time since diagnosis was 1.6 y. A total of 62.2% pts had ECOG PS 0, and 70.3% received bridging therapies (corticosteroids, alkylating agents, immunomodulatory agents, proteasome inhibitors [PI], and/or anti-CD38 antibodies) for MM. At study entry, 13.5%/51.4%/5.4% pts had R-ISS stage I/II/III disease, 32.4% had high-risk cytogenetics, 18.9% had bone marrow biopsy-determined high tumor burden (≥50% bone marrow CD138+ plasma cells), and 8.1% had extramedullary disease. Most pts had disease refractory to an immunomodulatory agent (86.5%) or PI (89.2%); 86.5% had double refractory disease.

At data cut-off (14 Mar 2022), median follow-up was 21.5 mo (range 2-31). CRR was 45.9% (95% CI 29.5-63.1), and ORR was 83.8% (95% CI 68.0-93.8) (Table 1). At 6 mo post-ide-cel, MRD− was observed in 11/13 (85%; 95% CI 57.8-95.7) pts. At 12 mo, MRD− was observed in 7/10 (70%; 95% CI 39.7-89.2) pts; of the 7 pts, 1 had PD at 20.8 mo, 5 sustained MRD− at ≥18 mo, and >12 mo data was unavailable for 1 pt. Median TTR was 1 mo (range 0.9-2.9). Median DOR was 15.7 mo (95% CI 7.62-19.81). Median PFS was 11.4 mo (95% CI 5.55-19.58); median OS was not reached. Time to event endpoint results for DOR, PFS, and OS are shown in Table 1.

Grade (Gr) 3-4 AEs on or after ide-cel infusion occurred in all pts, most commonly neutropenia in 35 (94.6%) pts, anemia in 17 (45.9%), and thrombocytopenia in 14 (37.8%). Two pts died due to pneumonia and pseudomonal sepsis. Gr 1/2 cytokine release syndrome (CRS) occurred in 30 (81.1%) pts; 1 (2.7%) pt had a Gr 3 event (Table 1). Gr 1/2 investigator-identified neurotoxicity (NT) occurred in 8 (21.6%) pts; no pts had ≥Gr 3 NT.

Robust cell expansion was seen in 36 evaluable pts (Table 2). Ide-cel cellular expansion levels were higher in pts who had ≥CR vs those who had <CR with ide-cel (Table 2). sBCMA (range 15.0-737.0 ng/mL at infusion, n = 36) was cleared within 2 mo post-ide-cel infusion in 25/37 (67.6%) pts, including all pts who had ≥CR.

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Trial Links

Read the latest news and updates on this trial.

Highly Refractory Myeloma Has Deep and Durable Responses With Ide-cel

December 05, 2020

Patients with heavily pretreated multiple myeloma maintained durable responses with the chimeric antigen receptor (CAR) T-cell therapy idecabtagene vicleucel (ide-cel; bb2121) in updated findings presented from the phase 1 CRB-401 trial (NCT02658929).

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Updated Results of Ongoing Multicenter Phase I Study of bb2121 anti-BCMA CAR T Cell Therapy Continue to Demonstrate Deep and Durable Responses in Patients with Late-Stage Relapsed/Refractory Multiple Myeloma at ASCO Annual Meeting

June 01, 2018

Celgene Corporation and bluebird bio, Inc. today announced updated results from the ongoing CRB-401 phase I clinical study of bb2121, an investigational anti-B-cell maturation antigen (BCMA) CAR T cell therapy, in 43 patients with late-stage relapsed/refractory multiple myeloma.

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Recruitment on Hold

Beth Israel Deaconess Medical Center

Boston, MA

Recruitment on Hold

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

Nebraska

University of Nebraska Medical Center Fred & Pamela Buffett Cancer Center

Omaha, NE

Open and Accepting

New Jersey

John Theurer Cancer Center at Hackensack University Medical Center  Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

New York

Herbert Irving Comprehensive Cancer Center (Columbia University) Columbia University Medical Center

New York, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

North Carolina

Atrium Health's Levine Cancer Institute - Charlotte (Main) Atrium Health

Charlotte, NC

Open and Accepting

Tennessee

Sarah Cannon Research Institute at Tennessee Oncology TriStar Centennial Medical Center

Nashville, TN

Recruitment on Hold

Texas

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Recruitment on Hold

Washington

Swedish Cancer Institute - Cherry Hill Campus

Seattle, WA

Open and Accepting
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