Belantamab Mafodotin for Multiple Myeloma
(DREAMM-3 Trial)

Recruiting in Palo Alto (17 mi)

+146 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called belantamab mafodotin in patients with multiple myeloma that has returned or not responded to treatment. Belantamab mafodotin targets cancer cells directly, while pomalidomide boosts the immune system, and dexamethasone controls inflammation.

Eligibility Criteria

Adults with relapsed/refractory multiple myeloma who've had at least two prior treatments, including lenalidomide and a proteasome inhibitor, can join. They must have measurable disease levels, adequate organ function, and no major surgery or active infections recently. Pregnant women, those with certain medical conditions or previous BCMA-targeted therapy are excluded.

Inclusion Criteria

Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

My side effects from previous treatments are mild, except for hair loss and some nerve pain.

I am at least 18 years old, or over 19 if I am from the Republic of Korea.

+7 more

Exclusion Criteria

I have had pneumonitis treated with steroids or have it now.

I am currently experiencing bleeding from an internal site.

I have symptoms of amyloidosis, POEMS syndrome, or plasma cell leukemia currently.

+19 more

Participant Groups

The trial compares belantamab mafodotin (administered every three weeks) against pomalidomide plus low-dose dexamethasone (pomalidomide daily for 21 days of a 28-day cycle; dexamethasone weekly). Participants will be randomly assigned to one of these treatments until their disease progresses or they experience unacceptable side effects.

2Treatment groups

Experimental Treatment

Active Control

Group I: Participants receiving Belantamab mafodotinExperimental Treatment1 Intervention

Participants will receive belantamab mafodotin single agent dose on Day 1 of Q3W

Group II: Participants receiving pom/dexActive Control1 Intervention

Participants will receive pomalidomide daily on Days 1 to 21 of each 28-day cycle, with dexamethasone once weekly on Days 1, 8, 15 and 22.

Belantamab Mafodotin is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Blenrep for: