At a glance
ClinicalIndex Comparison RecordPhase 1Active· 30 enrolled / 30 target
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.
A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5- Sub-study 5 - Belantamab Mafodotin and Isatuximab in Combination
In Brief
A Phase 1 clinical trial evaluating Belantamab mafodotin and Isatuximab for Multiple Myeloma. Active but no longer recruiting, targeting 30 participants across 19 sites in 11 countries.
Signals
Enrollment appears stalled
Detailed Summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with isatuximab, and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesAustralia, Brazil, Canada, France, Greece, Mexico, Norway, South Korea, Spain, Sweden, United States
Collaborators--
Timeline
Phase 1Active
202220232024202520262027
Enrollment StartJul 2021
Primary CompletionApr 2025
First PostedOct 2025
TodayJul 2026
Study CompletionMar 2027
First PostedOct 15, 2025
Enrollment StartJul 29, 2021
Primary CompletionApr 17, 2025
Study CompletionMar 11, 2027
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9 months ago
Arms & Interventions
Belantamab mafodotin + Isatuximabexperimental
Drug: Belantamab mafodotinDrug: Isatuximab
Interventions
Belantamab mafodotindrug
Belantamab mafodotin will be administered.
Isatuximabdrug
Isatuximab will be administered.