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Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

Myeloma Multiple Clinical Trial

Official title:
Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05091372
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Qaiser Bashir
Phone (713) 794-4422
Email qbashir@mdanderson.org
Status Recruiting
Phase Phase 2
Start date December 1, 2022
Completion date March 31, 2025
View Details
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