Active — Not RecruitingPhase 3

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

United States494 participantsStarted 2020-05-07

Plain-language summary

This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Urine M-protein excretion \>=200 mg per 24-hour, or
✓. Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or
✓. Serum free light chain (FLC) assay: involved FLC level \>=10 mg per dL (\>=100 mg per liter) and an abnormal serum free light chain ratio (\<0.26 or \>1.65).

What they're measuring

Progression-free Survival (PFS)

Timeframe: Up to approximately 41 months

Trial details

NCT IDNCT04246047

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-02

Results submitted2024-09-27

View on ClinicalTrials.gov More Multiple Myeloma trials