Cancer Type: Malignant Hematology
Study Type: Treatment
Phase: Phase II
Principal Investigator: Nishihori, Taiga
Phase II Multicenter Trial of anti-B Cell Maturation Antigen Chimeric Antigen Receptor T Cell Therapy for Multiple Myeloma Patients with Sub-Optimal Response After Autologous Hematopoietic Cell Transplantation and Maintenance Lenalidomide
This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with multiple myeloma (MM).
Primary Objective: The primary objective of this trial is to evaluate the efficacy of BCMA CAR T cell therapy to improve the response in patients who received an upfront autologous HCT and lenalidomide maintenance Clinical Secondary Objective: Clinical secondary objectives include: Assessment of disease progression, best disease response as described by conversion to MRD negativity and upgrade in clinical disease response, non-relapse mortality, progression free survival, incidence of CRS, incidence of prolonged cytopenias, and incidence of neurotoxicity. Exploratory Objectives: Exploratory objectives to be described include: Incidence of toxicities greater than or equal to grade 3 per CTCAE version 5.0, incidence of infections per protocol-specific MOP, feasibility of reinitiating maintenance, overall survival, disease response, CAR T-cell Expansion, CAR T-cell persistence, BCMA expression, immune reconstitution
Cell Therapy; Chemotherapy (NOS); Therapy (NOS)
CC-5013 (Lenalidomide); Diphenhydramine (); Lenalidomide (Revlimid); acetaminophen (); bb2121 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
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