CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 325 enrolled
Drug / intervention
Belantamab mafodotin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04162210
NCT04162210Phase 3Active
CompareCT.gov

A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)

GlaxoSmithKline·interventional·Posted Nov 14, 2019·Updated Mar 31, 2026

In Brief

A Phase 3 clinical trial evaluating Belantamab mafodotin and Pom/dex (Pomalidomide plus low dose Dexamethasone) for Multiple Myeloma. Active but no longer recruiting, targeting 325 participants across 102 sites in 19 countries.

Detailed Summary

This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesAustralia, Belgium, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hungary, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
20202021202220232024202520262027
First PostedNov 14, 2019
Enrollment StartApr 2, 2020
Primary CompletionSep 12, 2022
Study CompletionMar 11, 2027
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.6 years ago

Interventions

Belantamab mafodotindrug

Belantamab mafodotin will be administered.

Pom/dex (Pomalidomide plus low dose Dexamethasone)drug

Pomalidomide and Dexamethasone will be administered.