Study on Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone for Relapsed/Refractory Multiple Myeloma
Sponsor: Massachusetts General Hospital
ClinicalTrials ID:NCT05922501
This phase II clinical trial is testing a combination of four drugs to see how well they work in treating multiple myeloma that has returned or not responded to previous treatments. The study focuses on the overall response rate to the treatment.
Patient Parameters
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Program Overview
The main goal of this study is to evaluate how effective a combination of four drugs—Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone—is in treating patients with multiple myeloma that has come back or is not responding to other treatments. About 50 participants will be involved, and the treatment will continue until the disease progresses, side effects become too severe, or the participant decides to stop.
Description
This study involves four drugs: Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone, which are being tested together to see if they can help patients with multiple myeloma that has returned or is not responding to previous treatments. The study will include around 50 participants, and the main focus is to see how well the treatment works overall. Participants will continue with the treatment until their disease progresses, they experience significant side effects, or they choose to withdraw from the study.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of multiple myeloma with measurable disease.
- Must have previously received at least one line of therapy, including lenalidomide and a proteasome inhibitor.
- Must have experienced disease progression on or within 60 days of the last therapy.
- Must have adequate blood counts and organ function as determined by specific tests.
- Must be able to take aspirin or other blood thinners as a precaution.
- Women of childbearing potential must agree to use effective contraception and undergo regular pregnancy testing.
- Men must agree to use birth control and not donate sperm during and for six months after treatment.
- Must be able to swallow capsules whole.
Exclusion Criteria
- Cannot have current or severe eye problems.
- Cannot use contact lenses during the study.
- Cannot have received myeloma therapy or investigational drugs within two weeks before starting the study.
- Cannot have had certain antibody therapies recently.
- Cannot have had plasmapheresis within seven days before starting the study.
- Cannot have primary refractory disease.
- Cannot be pregnant or breastfeeding.
- Cannot have had other cancers unless treated and disease-free for at least three years, with some exceptions.
- Cannot have active plasma cell leukemia, POEMS syndrome, or primary AL amyloidosis.
- Cannot be HIV positive or have active hepatitis B or C.
- Cannot have severe peripheral neuropathy.
- Cannot have allergies to the study drugs.
- Cannot have had a recent stem cell transplant or be on immunosuppressive treatment.
- Cannot have significant heart, lung, liver, or other serious health issues.
- Cannot have had major surgery or received live vaccines recently.
- Must have resolved any side effects from previous cancer treatments to a manageable level.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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