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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)

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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