Spots Global Cancer Trial Database for Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma
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Trial Identification
Brief Title: Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma
Official Title: A Phase 2, Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma
Study ID: NCT03361748
Conditions
Interventions
Study Description
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.
Detailed Description: Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 108, San Francisco, California, United States
Local Institution - 103, Atlanta, Georgia, United States
Local Institution - 107, Boston, Massachusetts, United States
Local Institution - 106, Boston, Massachusetts, United States
Local Institution - 105, Rochester, Minnesota, United States
Local Institution - 102, Hackensack, New Jersey, United States
Local Institution - 109, New York, New York, United States
Local Institution - 101, Nashville, Tennessee, United States
Local Institution - 104, Dallas, Texas, United States
Local Institution - 201, Leuven, , Belgium
Local Institution - 301, Toronto, Ontario, Canada
Local Institution - 402, Lille, , France
Local Institution - 401, Nantes, , France
Local Institution - 502, Heidelberg, , Germany
Local Institution - 503, Tübingen, , Germany
Local Institution - 501, Würzburg, , Germany
Local Institution - 602, Bergamo, , Italy
Local Institution - 601, Bologna, , Italy
Local Institution - 803, Isehara City, Kanagawa, , Japan
Local Institution - 801, Shibuya-ku, , Japan
Local Institution - 802, Shimotsuke, , Japan
Local Institution - 804, Shinjuku City, , Japan
Local Institution - 702, Badalona (Barcelona), , Spain
Local Institution - 701, Pamplona, , Spain
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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