Active — Not RecruitingPhase 3

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

Japan24 participantsStarted 2021-07-28

Plain-language summary

This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Japanese participants with relapsed refractory multiple myeloma.

Who can participate

Age range18 Years

SexALL

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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 32 months

Trial details

NCT IDNCT06868667

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-03

Results submitted2025-04-03

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