Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma (NCT05032820) | Clinical Trial Compass
CompletedPhase 2
Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma
United States40 participantsStarted 2022-01-05
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age greater than or equal to 18.00 years
✓. Patients must meet the criteria for symptomatic MM requiring therapy (Appendix A) prior to initiating initial systemic anti-myeloma treatment.
✓. Patients must have received initial systemic anti- myeloma therapy consisting of induction therapy and consolidation with high-dose melphalan (\>140 mg/m\^2 ) followed by an auto HCT (minimum cell dose of 2x10\^6 CD34+ cells/kg (actual body weight) within 12 months from initiation of systemic anti-myeloma therapy.
✓. Patient must have additional stored stem cells greater than or equal to 2x10\^6 CD34+ cells per kg actual body weight.
✓. Patients must be less than or equal to 12 months after autologous HCT at the time of enrollment.
✓. Patients must have initiated maintenance therapy with lenalidomide-based regimen within 6 months after the auto HCT and have received at least 3 months of maintenance prior to enrollment.
✓. Patients must have tolerated a minimum dose of lenalidomide 5 mg/day for 21 days of a 28-day cycle for greater than 2 cycles without having to stop due to toxicities.
✓. Patients must have a VGPR or less (Section 3.1) in reference to time time of initiation of initial systemic anti-myeloma therapy at study enrollment.
Exclusion criteria
✕. Patients with a prior allogeneic hematopoietic cell.
✕. Female of childbearing potential (FCBP) is a female who: