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Phase 2 Trial of Belantamab Mafodotin Consolidation Treatment in Patients With Multiple Myeloma and MRD Positivity After Autologous Stem Cell Transplantation
This phase II trial investigates the effect of belantamab mafodotin and lenalidomide on minimal residual disease negative rates in patients with multiple myeloma with minimal residual disease positive after stem cell transplant. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell maturation antigen (BCMA) receptors, and delivers mafodotin to kill them. Lenalidomide may help block the formation of growths that may become cancer, and is used as a standard of care treatment for multiple myeloma. Giving belantamab mafodotin and lenalidomide may help to maintain minimal residual disease negativity in patients with multiple myeloma.
PRIMARY OBJECTIVE: I. Assess the minimal residual disease (MRD) negative rate after 6 cycles of post autologous stem cell transplant consolidation with belantamab mafodotin and lenalidomide. SECONDARY OBJECTIVE: I. Assess sustained MRD negative rate, progression free survival (PFS) and overall survival (OS). OUTLINE: Patients receive belantamab mafodotin intravenously (IV) over 30 minutes on day 1 and lenalidomide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 8 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 12 weeks and the periodically for up to 5 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Roswell Park Cancer Institute
Buffalo, New York, United States
Start Date
August 19, 2024
Primary Completion Date
September 1, 2026
Completion Date
September 1, 2026
Last Updated
February 5, 2026
4
ACTUAL participants
Belantamab Mafodotin
BIOLOGICAL
Lenalidomide
DRUG
Lead Sponsor
Roswell Park Cancer Institute
Collaborators
NCT06356571
NCT05334069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05312255