Belantamab Mafodotin vs. Daratumumab for Multiple Myeloma
(DREAMM 7 Trial)

Recruiting in Palo Alto (17 mi)

+181 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 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.

Eligibility Criteria

This trial is for people with multiple myeloma who've had at least one prior treatment and whose disease has gotten worse after their most recent therapy. They must have good organ function, a performance status showing they can handle daily activities, and measurable signs of the disease. People with eye diseases affecting the cornea, intolerance to certain drugs used in this study, ongoing severe nerve pain or damage, previous treatments targeting BCMA or an allogenic stem cell transplant cannot join.

Inclusion Criteria

All my previous cancer treatment side effects are mild, except for hair loss.

My organs are working well.

I have been diagnosed with multiple myeloma according to IMWG standards.

+3 more

Exclusion Criteria

I can't tolerate bortezomib or my condition worsened on it.

My condition worsened during or within 2 months after anti-CD38 therapy.

I have had a stem cell transplant from a donor.

+5 more

Participant Groups

The study compares two combinations of cancer drugs in patients with relapsed multiple myeloma: Belantamab Mafodotin with Bortezomib/Dexamethasone versus Daratumumab with Bortezomib/Dexamethasone. It's randomized and open-label so participants know which treatment they're getting.

2Treatment groups

Experimental Treatment

Active Control

Group I: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)Experimental Treatment3 Interventions

Group II: Daratumumab and Bortezomib plus Dexamethasone (Arm B)Active Control3 Interventions

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

🇪🇺 Approved in European Union as Blenrep for: