NCT04196491: Phase 1 - Evaluate the Safety of bb2121 in High Risk, New Myeloma (NDMM) (KarMMa-4)
Updated: Feb 5
KarMMa-4
A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM) (KarMMa-4)
Relapsed & Refractory Multiple Myeloma
This is a multicenter, open-label, phase 1, single arm study intended to determine the optimal target dose and safety of bb2121 in subjects with HR (R-ISS Stage III per IMWG criteria) NDMM. Subjects should have received 3 Cycles of standard induction therapy prior to undergoing leukapheresis procedure to collect autologous mononuclear cells for manufacture of the drug product (bb2121). Following manufacture of the drug product, subjects will receive fourth cycle of induction therapy followed by lymphodepleting therapy with fludarabine and cyclophosphamide prior to bb2121 infusion. Maintenance therapy is recommended for all subjects who have received bb2121 infusion and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later.
Sponsor
Bristol Myers Squibb
ClinicalTrials.gov Identifier: NCT0419649
Official Title: A Phase 1, Open-label, Multicenter Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (KarMMa-4)
First Posted: December 12, 2019
Click here for details on ClinicalTrials.gov
idecabtagene vicleucel
Anti-BCMA CAR T Cells BB2121
anti-BCMA-CAR-transduced T cells BB2121
BCMA-specific CAR-expressing T lymphocytes BB2121
ide-cel
Abecma
BB2121
Bluebird Bio
Permitted induction regimens for cycle 1 are :
* carfilzomib + lenalidomide + dexamethasone ± daratumumab (KRd ± DARA),
* lenalidomide + bortezomib + dexamethasone ± daratumumab (RVd ± DARA), or
* cyclophosphamide + bortezomib + dexamethasone (CyBorD)
1418 KarMMa-4: Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-Directed CAR T-Cell Therapy, in High-Risk Newly Diagnosed Multiple Myeloma
Program: Oral and Poster Abstracts
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I
Saturday, December 5, 2020, 7:00 AM-3:30 PM
Meeting Abstract | 2021 ASCO Annual Meeting I
HEMATOLOGIC MALIGNANCIES—PLASMA CELL DYSCRASIA
KarMMa-4: Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T-cell therapy in high-risk newly diagnosed multiple myeloma
- Arizona: Mayo Clinic Arizona
- California: UCLA School of Medicine Los Angeles
- California: University of California San Francisco
- Florida: Mayo Clinic Jacksonville Florida
- Georgia: Emory University Atlanta
- Colorado: Sarah Cannon/Colorado Blood Cancer Institute Denver
- Massachusetts: Massachusetts General Hospital Boston
- New Jersey: Hackensack University Medical Center
- New York: Tisch Cancer Institute Mount Sinai Hospital New York
- New York: NYU Langone Medical Center New York
- North Carolina: Levine Cancer Institute Charlotte
- Tennessee: Sarah Cannon Research Institute Nashville
- Texas: UT Southwestern Medical Center Dallas
- Washington: Fred Hutchinson Cancer Center Seattle
- Wisconsin: Froedtert Memorial Milwaukee
Locations
United States, Arizona
United States, California
United States, Colorado
United States, Florida
United States, Georgia
United States, Massachusetts
United States, New Jersey
United States, New York
United States, North Carolina
United States, Oregon
United States, Pennsylvania
United States, Tennessee
United States, Texas
United States, Washington
United States, Wisconsin
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