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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

NCT05091372 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-03-05

No results posted yet for this study

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.

Conditions

  • Myeloma Multiple

Interventions

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Qaiser Bashir · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05091372 on ClinicalTrials.gov