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Belantamab Mafodotin, Lenalidomide, and Daratumumab for the Treatment of Relapsed, Refractory, or Previously Untreated Multiple Myeloma

NCT04892264 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-05-18

No results posted yet for this study

Summary

This phase I/II trial studies the best dose and effect of belantamab mafodotin given together with lenalidomide and daratumumab in treating patients with multiple myeloma that has come back (relapsed), does not respond to treatment (refractory) or for which the patient has not received treatment in the past (previously untreated). 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 BCMA receptors, and delivers mafodotin to kill them. Lenalidomide is an immunomodulatory drug (altering the immune effects on the tumor cell). Daratumumab is a drug that is a monoclonal antibody that is directed towards a protein on the myeloma cell. Giving belantamab mafodotin together with lenalidomide and daratumumab may kill more cancer cells.

Conditions

  • Plasma Cell Myeloma
  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma

Interventions

BIOLOGICAL

Belantamab Mafodotin

Given IV

BIOLOGICAL

Daratumumab

Given IV

DRUG

Dexamethasone

Given PO

DRUG

Lenalidomide

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Skeletal Survey X-Ray

Undergo X-ray skeletal survey

PROCEDURE

Low Dose Computed Tomography of the Whole Body

Undergo whole body low dose CT

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

Sponsors & Collaborators

Principal Investigators

  • Shaji K. Kumar, M.D. · Mayo Clinic in Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2024-03-18
Completion
2024-03-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04892264 on ClinicalTrials.gov