Spots Global Cancer Trial Database for A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)
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Trial Identification
Brief Title: A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)
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)
Study ID: NCT04196491
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 119, Phoenix, Arizona, United States
Local Institution - 110, Los Angeles, California, United States
Local Institution - 116, San Francisco, California, United States
Local Institution - 106, Denver, Colorado, United States
Local Institution - 101, Jacksonville, Florida, United States
Local Institution - 113, Tampa, Florida, United States
Local Institution - 108, Atlanta, Georgia, United States
Local Institution - 123, Atlanta, Georgia, United States
Local Institution - 115, Boston, Massachusetts, United States
Local Institution - 122, Boston, Massachusetts, United States
Local Institution - 117, Hackensack, New Jersey, United States
Local Institution - 121, New York, New York, United States
Local Institution - 109, New York, New York, United States
Local Institution - 124, New York, New York, United States
Local Institution - 120, Charlotte, North Carolina, United States
Local Institution - 112, Portland, Oregon, United States
Local Institution - 118, Philadelphia, Pennsylvania, United States
Local Institution - 103, Nashville, Tennessee, United States
Local Institution - 102, Dallas, Texas, United States
Local Institution - 114, Houston, Texas, United States
Local Institution - 104, Seattle, Washington, United States
Local Institution - 107, Milwaukee, Wisconsin, United States
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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