RecruitingPhase 2NCT05091372

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

94 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a maintenance therapy combination (belantamab mafodotin and lenalidomide) after a stem cell transplant for multiple myeloma — a type of blood cancer. The goal is to keep the cancer from coming back, especially in patients who still have traces of disease detectable after transplant. **You may be eligible if...** - You have been newly diagnosed with multiple myeloma and recently completed your first stem cell transplant (60 to 180 days after transplant) - You achieved at least a partial response to your transplant - You are between 18 and 75 years old - Your organ function (kidney, liver, blood counts) is adequate - You are willing to enroll in the required lenalidomide safety program (REMS) **You may NOT be eligible if...** - You have had more than one stem cell transplant - You are pregnant or breastfeeding - You have serious eye problems that would be worsened by belantamab mafodotin - Your organ function does not meet minimum requirements - You are unwilling to use reliable birth control Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBelantamab 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.

DRUGLenalidomide

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.

Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT05091372