Study on Elotuzumab with Pomalidomide, Bortezomib, and Dexamethasone for Treating Relapsed Multiple Myeloma
Sponsor: Massachusetts General Hospital
ClinicalTrials ID:NCT02718833
This clinical trial is exploring a combination of four drugs—elotuzumab, pomalidomide, bortezomib, and dexamethasone—as a potential treatment for patients with multiple myeloma that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The purpose of this study is to test the safety and effectiveness of a combination of four drugs—elotuzumab, pomalidomide, bortezomib, and dexamethasone—in treating multiple myeloma that has come back or is resistant to treatment. Each of these drugs is already approved by the FDA for treating this type of cancer. Pomalidomide helps the immune system fight cancer cells, bortezomib blocks cancer cell growth, dexamethasone reduces inflammation and fights myeloma cells, and elotuzumab targets a specific protein on myeloma cells. The combination may offer a new way to treat the disease.
Description
This study is a Phase II clinical trial, which means it is focused on testing the safety and how well the combination of elotuzumab, pomalidomide, bortezomib, and dexamethasone works in patients with relapsed or refractory multiple myeloma. All four drugs are approved by the FDA for treating this condition.
- Pomalidomide: Enhances the immune system to help destroy cancer cells.
- Bortezomib: Blocks the process that cancer cells use to dispose of proteins, helping to kill them.
- Dexamethasone: A steroid that reduces inflammation and acts against myeloma cells.
- Elotuzumab: A monoclonal antibody that targets a protein common on myeloma cells, helping the immune system attack them.
The study aims to see if this combination can provide a unique and effective approach to treating multiple myeloma.
Eligibility Criteria
Inclusion Criteria
- Must have lab tests done within 21 days before starting the study treatment.
- Must sign a consent form agreeing to participate in the study.
- Must be 18 years or older.
- Must have measurable multiple myeloma, as defined by specific protein levels in the blood or urine.
- Must have previously treated relapsed and refractory multiple myeloma, with at least one prior therapy including lenalidomide and a proteasome inhibitor.
- Must have adequate blood counts and organ function, as determined by specific lab tests.
- Must be able to take daily aspirin or another blood thinner as a precaution.
- Must be registered in the POMALYST REMS program and comply with its requirements.
- Must be able to swallow capsules whole.
Exclusion Criteria
- Cannot have had prior therapy with elotuzumab.
- Cannot have had chemotherapy or radiotherapy within 2 weeks before starting the study, except for dexamethasone.
- Cannot be receiving other investigational drugs.
- Cannot be on high-dose corticosteroids, except for certain conditions.
- Cannot be pregnant or breastfeeding.
- Cannot have had other cancers within the last 3 years, except for certain skin or cervical cancers.
- Cannot have plasma cell leukemia, POEMS syndrome, or amyloidosis.
- Cannot have active HIV or hepatitis B or C infections.
- Cannot have severe nerve damage despite treatment.
- Cannot have allergies to any of the study drugs.
- Cannot have had a stem cell transplant within the last 12 months or be on immunosuppressive treatment.
- Cannot have significant heart, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illnesses that could interfere with the study.
- Cannot have any other medical, psychiatric, or social conditions that would interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hospital Cancer Center | 02114 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02115 | Boston | Massachusetts |
| Mass General/North Shore Cancer Center | 01923 | Danvers | Massachusetts |
| Newton-Wellesley Hospital | 02462 | Newton | Massachusetts |
| University of Michigan | 48109 | Ann Arbor | Michigan |
| University of Rochester | 14642 | Rochester | New York |
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