Trial intelligence / Profile preview

Belantamab mafodotin in RRMM (DREAMM-2)

NCT03525678Phase 2

Key facts

Status: Completed
Start: Jun 2018
Primary completion: Jun 2019
Countries: 8
Sponsor: GSK
Modality: Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs)

Drugs: belantamab mafodotin
Conditions: multiple myeloma (MM)

Overview

Phase 2, randomised, open-label trial of belantamab mafodotin in multiple myeloma (MM) (3 arms), sponsored by GSK. Primary endpoint: Overall Response Rate up to 48 weeks. Started Jun 2018; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

Frozen 2.5 mg/kg
Belantamab mafodotin 2.5 mg/kg IV Q3W
Frozen 3.4 mg/kg
Belantamab mafodotin 3.4 mg/kg IV Q3W
Lyophilized
Belantamab mafodotin lyophilized formulation IV Q3W

Who it enrols

Adults with RRMM who have received at least 3 prior lines of therapy, are refractory to a proteasome inhibitor and an immunomodulatory agent, and have failed an anti-CD38 antibody.

Endpoints

Primary

Overall Response RateUp to 48 weeks

Secondary

Duration of ResponseUp to 186 weeks
Progression-Free SurvivalUp to 186 weeks
Overall SurvivalUp to 186 weeks
Time to ResponseUp to 186 weeks
Clinical Benefit RateUp to 186 weeks
Adverse EventsUp to 186 weeks
Ocular Adverse EventsUp to 186 weeks
PharmacokineticsCycle 3

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