Iberdomide + Belantamab Mafodotin + Dexamethasone for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I/II trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Multiple myeloma is a cancer that affects white blood cells called plasma cells, which are made in the bone marrow and are part of the immune system. Multiple myeloma cells have a protein on their surface called B-cell maturation antigen (BCMA) that allows the cancer cells to survive and grow. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Belantamab mafodotin has been designed to attach to the BCMA protein, which may cause the myeloma cell to become damaged and die. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma.

Eligibility Criteria

This trial is for adults with multiple myeloma that has returned or isn't responding to treatment. Participants must have had at least two prior treatments and been exposed to specific drug classes, but not previously treated with iberdomide, belamaf, BCMA-directed therapy, or any monoclonal antibody within the last 2 weeks.

Inclusion Criteria

I have never had BCMA-targeted treatment.

I haven't had monoclonal antibody treatment in the last 2 weeks.

My blood tests show a 25% change in certain proteins or I have new cancer growths or high calcium.

+7 more

Participant Groups

The trial is testing a combination of an experimental drug called Iberdomide with two approved drugs: Belantamab Mafodotin and Dexamethasone. It aims to find out the safest dose and how effective this combo is in slowing down or stopping cancer growth in patients with relapsed/refractory multiple myeloma.

3Treatment groups

Experimental Treatment

Active Control

Group I: Phase II, Arm II (iberdomide, belantamab mafodotin)Experimental Treatment10 Interventions

Patients receive iberdomide orally on days 1-21 and 29-49, belantamab mafodotin IV on day 1, and dexamethasone PO on days 1, 8, 15, 22, 29, 36, 43, and 50 of each cycle. Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening as clinically indicated and CT, MRI and/or PET scans during screening and as clinically indicated on study. Patients also undergo bone marrow biopsy and aspiration and blood sample collection throughout trial.

Group II: Phase I (iberdomide, belantamab mafodotin, dexamethasone)Experimental Treatment10 Interventions

Patients receive iberdomide orally on days 1-21 and 29-49, belantamab mafodotin IV on day 1, and dexamethasone PO on days 1, 8, 15, 22, 29, 36, 43, and 50 of each cycle. Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening as clinically indicated and CT, MRI and/or PET scans during screening and as clinically indicated on study. Patients also undergo a bone marrow biopsy and aspiration and blood sample collection throughout trial.

Group III: Phase II, Arm I (belantamab mafodotin, dexamethasone)Active Control9 Interventions

Patients receive belantamab mafodotin IV on day 1 and dexamethasone PO on days 1, 8, 15, 22, 29, 36, 43, and 50 of each cycle. Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients who progress may cross over to Arm II. Patients undergo ECHO during screening as clinically indicated and CT, MRI and/or PET scans during screening and as clinically indicated on study. Patients also undergo a bone marrow biopsy and aspiration and blood sample collection throughout trial.