drugset / Trial / NCT05032820
Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma
Phase 2
Completed
40 enrolled
Medical College of Wisconsin
Blood and Marrow Transplant Clinical Trials Network · collabCelgene a wholly owned subsidiary of BMS · collabNational Cancer Institute (NCI) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabNational Marrow Donor Program · collab
NaSingle-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2022-01-05
- Primary completion
- 2024-08-22
- Completion
- 2025-02-20
Outcome
Met primary endpoint
registry p <0.0001; Proportion of Patients Achieving CR/sCR 65.8 (90% CI 51.2 to 78.4) NCT05032820 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | idecabtagene vicleucel | Cell therapy | 4.5e+08 cells | — |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |
| Background | Lenalidomide | Other / unclassified | 5 mg | — |