Belantamab Mafodotin or Lenalidomide Maintenance
Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
What will happen during the trial?
Primary Objective:
-To increase the conversion rate from MRD-positive to MRD-negative CR in patients with newly diagnosed multiple myeloma (NDMM) receiving post-transplant maintenance therapy with belantamab mafodotin plus lenalidomide.
Secondary Objectives:
- To determine the safety and tolerability of belantamab mafodotin plus lenalidomide maintenance therapy after auto-HCT.
- To increase the overall MRD-negative CR rate in patients with NDMM receiving post-auto-HCT maintenance therapy with belantamab mafodotin plus lenalidomide.
- To determine the PFS and OS in patients who discontinue maintenance therapy after achieving sustained MRD-negative CR. Sustained MRD-negative CR is defined as MRD-negative status in two assessments, at least 1-year apart, without any MRD-positive status in between.
- To determine the PFS with belantamab mafodotin plus lenalidomide maintenance therapy after auto-HCT in patients with NDMM.
- To determine the OS with belantamab mafodotin plus lenalidomide maintenance therapy after auto-HCT in patients with NDMMM.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 2
- Enrollment
- 94 patients (estimated)
- Sponsors
- MD Anderson Cancer Center
- Tags
- Immunomodulatory Drug (IMiD), Antibody Drug Conjugate (ADC), B-Cell Maturation Antigen (BCMA), Maintenance, Randomization
- Trial Type
- Treatment
- Last Update
- SparkCures ID
- 1900
- NCT Identifier
- NCT05091372
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