Isatuximab + Belantamab for Multiple Myeloma
(ISABELA Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byAndrew Yee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.

Research Team

Andrew Yee, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults with relapsed/refractory multiple myeloma who have adequate liver function, can take aspirin daily, and are not pregnant or breastfeeding. Participants must agree to contraception methods and join the Pomalyst REMS program. They should be able to swallow capsules whole, have an ECOG status ≤ 2, certain levels of hemoglobin and measurable disease indicators.

Inclusion Criteria

I am 18 years old or older.

My liver is functioning well.

My hemoglobin level is at least 8 g/dL, possibly after a blood transfusion.

See 14 more

Exclusion Criteria

I had a stem cell transplant using my own cells less than 6 months ago.

I had a stem cell transplant from a donor less than a year ago.

Side effects from my past cancer treatment have mostly gone away.

See 19 more

Treatment Details

Interventions

Belantamab mafodotin (Monoclonal Antibodies)
Dexamethasone (Corticosteroid)
Isatuximab (Monoclonal Antibodies)
Pomalidomide (Other)

Trial OverviewThe trial is testing a combination of drugs: Isatuximab, Belantamab Mafodotin (Bela Maf), Pomalidomide (Pom), and Dexamethasone (Dex) for their effectiveness in treating multiple myeloma that has come back or hasn't responded to treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Isatuximab + Belantamab mafodotin + Pomalidomide + DexamethasoneExperimental Treatment4 Interventions

Isatuximab will be given once daily into your vein (by intravenous infusion) over about 30-60 minutes. This will occur during cycle 1 (cycle equals 28 days) on days 1, 8, 15, and 22 and cycle 2 and onwards days 1 and 15. Belantamab mafodotin will be given once every 8 weeks into your vein (by intravenous infusion) over about 60 minutes after completion of isatuximab infusion. Pomalidomide will be taken orally once daily during days 1-21 of each cycle. Dexamethasone will be taken orally once daily during days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle. Drug diaries will be provided to participants to document information about taking pomalidomide and dexamethasone.