Study of bb2121 in Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT02658929 |
Recruitment Status :
Completed
First Posted : January 20, 2016
Last Update Posted : January 23, 2023
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Tracking Information | ||||
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First Submitted Date ICMJE | January 15, 2016 | |||
First Posted Date ICMJE | January 20, 2016 | |||
Last Update Posted Date | January 23, 2023 | |||
Actual Study Start Date ICMJE | December 22, 2015 | |||
Actual Primary Completion Date | July 22, 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs) [ Time Frame: Day 1 through Month 60 ] | |||
Original Primary Outcome Measures ICMJE |
Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs) [ Time Frame: Day 1 through Month 24 ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Disease-specific response criteria including: overall response rate (ORR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for MM. [ Time Frame: Day 1 through Month 60 ] Percentage of subjects who achieved a CR, VGR, PR according to IMWG Uniform Response Criteria for Multiple Myeloma (MM).
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Original Secondary Outcome Measures ICMJE |
Disease-specific response criteria including: complete response (CR), very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma [ Time Frame: Month 1 through Month 24 ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of bb2121 in Multiple Myeloma | |||
Official Title ICMJE | CRB-401 A Phase 1 Study of bb2121 in BCMA-Expressing Multiple Myeloma | |||
Brief Summary | Study CRB-401 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb2121 in adults with relapsed/refractory multiple myeloma (MM). | |||
Detailed Description | This is a 2-part, non-randomized, open label, multi-site Phase 1 study. the study design consists of 2 parts: Part A (Dose Escalation), in which the RP2D is determined, and Part B (Expansion Cohorts), in which subjects are treated with the determined RP2D. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (bb2121). Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to bb2121 infusion. All subjects who have received bb2121 infusion will be followed for up to 60 months on CRB-401. All subjects who complete the study, as well as those who withdraw from the study after receiving bb2121 for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo long-term follow-up in a companion study for up to 15 years after their last bb2121 infusion, with a focus on long-term safety and efficacy. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Multiple Myeloma | |||
Intervention ICMJE | Biological: bb2121
bb2121
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Study Arms ICMJE | Experimental: bb2121
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
Intervention: Biological: bb2121
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Publications * | Raje N, Berdeja J, Lin Y, Siegel D, Jagannath S, Madduri D, Liedtke M, Rosenblatt J, Maus MV, Turka A, Lam LP, Morgan RA, Friedman K, Massaro M, Wang J, Russotti G, Yang Z, Campbell T, Hege K, Petrocca F, Quigley MT, Munshi N, Kochenderfer JN. Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2019 May 2;380(18):1726-1737. doi: 10.1056/NEJMoa1817226. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
67 | |||
Original Estimated Enrollment ICMJE |
50 | |||
Actual Study Completion Date ICMJE | September 22, 2022 | |||
Actual Primary Completion Date | July 22, 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Serum M-protein greater or equal to 0.5 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 -Women of child-bearing potential (WCBP) must have a negative serum pregnancy test prior to treatment and refrain from tissue donation including egg donation or any other tissue/blood/organ donations, for at least 1 year following bb2121 infusion. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study. All sexually active males subjects must refrain from tissue donation including egg donation or any other tissue/blood/organ donations, for at least 1 year following bb2121 infusion. Part A: Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor (e.g., bortezomib or carfilzomib) and immunomodulatory therapy (IMiD; e.g., lenalidomide or pomalidomide), or have "double refractory" disease to a proteasome inhibitor and IMiD, defined as progression on or within 60 days of treatment with these agents - Part B: Diagnosis of MM with relapsed or refractory disease with previous exposure to PI (e.g., bortezomib or carfilzomib), IMiDs (e.g., lenalidomide or pomalidomide), and daratumumab, and refractory (based on IMWG criteria) to their last line of therapy Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02658929 | |||
Other Study ID Numbers ICMJE | CRB-401 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Celgene | |||
Original Responsible Party | bluebird bio | |||
Current Study Sponsor ICMJE | Celgene | |||
Original Study Sponsor ICMJE | bluebird bio | |||
Collaborators ICMJE | bluebird bio | |||
Investigators ICMJE |
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PRS Account | Celgene | |||
Verification Date | January 2023 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |