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To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

NCT03544281 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-03-18

Study results available
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Summary

This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone \[Len/Dex (Treatment A)\] or Bortezomib Plus Dexamethasone \[Bor/Dex (Treatment B)\] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy.

Participants receiving treatment A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.

Conditions

Interventions

DRUG

Belantamab mafodotin

Selected doses of belantamab mafodotin will be administered as an infusion.

DRUG

Lenalidomide

Lenalidomide will be administered as 25 or 10 mg,orally, with belantamab mafodotin and dexamethasone.

DRUG

Dexamethasone

Dexamethasone will be administered as 20 or 40 mg, orally with belantamab mafodotin.

DRUG

Bortezomib

Bortezomib will be administered as 1.3 mg/m\^2, as SC or IV, with belantamab mafodotin and dexamethasone.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2023-02-28
Completion
2024-02-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
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 NCT03544281 on ClinicalTrials.gov