NCT05091372

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Myeloma Multiple

Interventions

Type	Name	Description
DRUG	Belantamab mafodotin	Belantamab Mafodotin Belantamab mafodotin dose levels: Dose level -2 = 1.4 mg/kg IV every 12 weeks Dose level -1 = 1.9 mg/kg IV every 12 weeks Dose level 0 = 1.9 mg/kg IV every 8 weeks Cycles 1 - 6: All patients will start at dose level 0. Cycles 7 and onwards\*: Patients previously on dose level 0 (1.9 mg/kg IV every 8 weeks) will change to dose level -1 (1.9 mg/kg IV every 12 weeks) Patients previously on dose level -1 (1.9 mg/kg IV every 12 weeks) will continue at the same dose level. Patients previously on dose level -2 (1.4 mg/kg IV every 12 weeks) will continue at the same dose level. \*Reduction to a lower dose level is allowed in case of development of adverse effects or poor tolerance as determined by the treating physician.
DRUG	Lenalidomide	Lenalidomide dose levels: Dose level 0 (starting dose): Lenalidomide 10 mg/day PO continuously. Dose level -1: Lenalidomide 10 mg/day PO. One week off after every three weeks of treatment. Dose level -2: Lenalidomide 5 mg/day PO. One week off after every three weeks of treatment.

Timeline

• Start date: 2022-12-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-10-25
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study