Belantamab Mafadotin Maintenance Therapy
Belantamab Mafadotin Maintenance Therapy After Salvage Autologous Hematopoietic Cell Transplantation in Patients With Relapse Refractory Multiple Myeloma
What will happen during the trial?
Primary Objective:
To determine the safety and tolerability of belantamab maintenance therapy after auto-HCT.
Secondary Objectives:
To estimate the complete remission rate (CRR) as defined by the International Myeloma Working Group (IMWG) criteria (Appendix A.) within 9 months post salvage autotransplant with single agent belantamab mafodotin maintenance therapy starting approximately 3 months post salvage auto-transplant in patients with relapsed myeloma.
To evaluate progression-free survival (PFS) and overall survival (OS) (from the data of initiation of maintenance therapy assessed up to 2 years)
To discover the impact of belantamab mafodotin on graft function and immune reconstitution.
• To assess minimal residual disease status (FDA approved MRD assay by flow cytometry - MRD measured down to 1 in 1 million cells, <106) after at 6 months and 1, 2, and 3 years after initiation of maintenance therapy.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 1
- Enrollment
- 20 patients (estimated)
- Sponsors
- MD Anderson Cancer Center
- Tags
- Antibody Drug Conjugate (ADC), B-Cell Maturation Antigen (BCMA), Post-Autologous Stem Cell Transplant
- Trial Type
- Treatment
- Last Update
- 1 month ago
- SparkCures ID
- 1218
- NCT Identifier
- NCT05065047
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