Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

NCT03361748 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: BB2121-MM-001U1111-1202-55542017-002245-29
• Study Type: interventional
• Target: 149
• Locations: 8 countries
• Sites: 48

Brief Summary

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 myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Efficacy and Safety; BB2121; CAR T Cell; BCMA; Relapsed and Refractory

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Number of participants who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an independent response committee (IRC).

  From first dose to 24 Months

Secondary Outcomes (20)

• Complete Response Rate

  From first dose to 24 Months

• Time to Response

  From first dose to initial response (approximately on average 1.2 months, max of 8.8 months)

• Duration of Response

  From first dose to 24 months after first dose

• Progression Free Survival (PFS)

  From first dose to 24 months after first dose

• Time to Progression (TTP)

  From first dose to 24 months after first dose

Study Arms (1)

Administration of bb2121

EXPERIMENTAL

bb2121 autologous CAR T cells will be infused at a dose ranging from 15 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy.

Biological: bb2121

Interventions

bb2121 BIOLOGICAL

: bb2121 consists of autologous T lymphocytes transduced with an anti-BCMA02 CAR lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).

Administration of bb2121

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility is determined prior to leukapheresis. Subjects must satisfy the following criteria to be enrolled in the study:
• Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Documented diagnosis of multiple myeloma
• Must have received at least 3 prior MM treatment regimens. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen.
• Must have undergone at least 2 consecutive cycles of treatment for each regimen, unless PD was the best response to the regimen.
• Must have received a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
• Must be refractory to the last treatment regimen.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Subjects must have measurable disease, including at least one of the criteria below:
• Serum M-protein greater or equal to 1.0 g/dL
• Urine M-protein greater or equal to 200 mg/24 h
• Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
• Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subjects with known central nervous system involvement with myeloma.
• History or presence of clinically relevant central nervous system (CNS) pathology.
• Subjects with active or history of plasma cell leukemia.
• Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease
• Inadequate organ function
• Ongoing treatment with chronic immunosuppressants
• Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy
• Evidence of human immunodeficiency virus (HIV) infection.
• Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV)
• Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) and Hepatitis C virus (HCV)
• Subjects with a history of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months.
• Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission
• Pregnant or lactating women.
• Subject with known hypersensitivity to any component of bb2121 productThe presence of any of the following will exclude a subject from enrollment:

Sponsors & Collaborators

• Celgene: lead

Study Sites (48)

Local Institution - 108

San Francisco, California, 94143, United States

Location

University of California - San Francisco

San Francisco, California, 94143, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Local Institution - 103

Atlanta, Georgia, 30322, United States

Location

Local Institution - 107

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Local Institution - 106

Boston, Massachusetts, 02215, United States

Location

Local Institution - 105

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 102

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 109

New York, New York, 10029, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

Local Institution - 101

Nashville, Tennessee, 37203, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Local Institution - 104

Dallas, Texas, 75390, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Universitaire Ziekenhuizen Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Local Institution - 201

Leuven, B-3000, Belgium

Location

Local Institution - 301

Toronto, Ontario, M5G 2M9, Canada

Location

Princess Margaret Cancer Centre

Toronto, M5G 2M9, Canada

Location

Centre Hospitalier Regional Universitaire de Lille-Hopital Calude Huriez Service des Maladies du Sang

Lille, Hauts-de-France, 59037, France

Location

Centre Hospitalier Universitaire de Nantes - Hotel Dieu

Nantes, Pays de la Loire Region, 44093, France

Location

Local Institution - 402

Lille, 59037, France

Location

Local Institution - 401

Nantes, 44093, France

Location

Universitatsklinikum Heidelberg Medizinische Klinik Krehl-Klinik Haematologie, Onkologie, Rheumato

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

University of Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitatsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

Location

Local Institution - 502

Heidelberg, 69120, Germany

Location

Local Institution - 503

Tübingen, 72076, Germany

Location

Local Institution - 501

Würzburg, 97080, Germany

Location

Azienda Ospedaliero Universitaria Di Bologna Policlinico

Bologna, Emilia-Romagna, 40138, Italy

Location

Local Institution - 602

Bergamo, 24128, Italy

Location

Ospedali Riuniti di Bergamo

Bergamo, 24128, Italy

Location

Local Institution - 601

Bologna, 40138, Italy

Location

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 3290498, Japan

Location

Japan Red Cross Medical Center

Shibuya-ku, Tokyo, 150-8935, Japan

Location

Local Institution - 803

Isehara City, Kanagawa, 259-1193, Japan

Location

Local Institution - 801

Shibuya-ku, 150-8935, Japan

Location

Local Institution - 802

Shimotsuke, 329-0498, Japan

Location

Local Institution - 804

Shinjuku, 162-8666, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku, 162-8666, Japan

Location

Hospital Universitari Germans Trias i Pujol Can Ruti

Badalona, Barcelona, 08916, Spain

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Local Institution - 702

Badalona (Barcelona), 08916, Spain

Location

Local Institution - 701

Pamplona, 31008, Spain

Location

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• Delforge M, Otero PR, Shah N, Moshkovich O, Braverman J, Dhanda DS, Lanar S, Devlen J, Miera M, Gerould H, Campbell TB, Munshi NC. Analysis of patient-reported experiences up to 2 years after receiving idecabtagene vicleucel (ide-cel, bb2121) for relapsed or refractory multiple myeloma: Longitudinal findings from the phase 2 KarMMa trial. Leuk Res. 2023 Jun;129:107074. doi: 10.1016/j.leukres.2023.107074. Epub 2023 Apr 3.

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Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

idecabtagene vicleucel

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

1-855-907-3286

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

• Kristen Hege

  Celgene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: December 13, 2017
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Locations

US (18); IT (4); BE (2); ES (4); FR (4); DE (6); JP (8); CA (2)