Multiple Myeloma Clinical Trial
Official title:
An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma
This research study is studying a combination of targeted therapies as a possible treatment
for multiple myeloma (MM).
The drugs involved in this study are:
- Elotuzumab
- Nivolumab
- Pomalidomide
- Dexamethasone
This research study is a Phase II clinical trial. Phase II clinical trials test the safety
and effectiveness of an investigational drug combination to learn whether the combination
works in treating a specific disease. "Investigational" means that the drug combination is
being studied.
This study has two parts. Each part tests a different combination of drugs.
- In Part 1 participants will be given elotuzumab and nivolumab.
- In Part 2 participants will be given elotuzumab, nivolumab, pomalidomide, and
dexamethasone.
Each of these drugs works in a different way to help the body fight multiple myeloma. The
drugs are being tested in different combinations to see if they are more effective when taken
together.
Elotuzumab is an antibody, that stimulates the immune system to fight your disease. The FDA
(the U.S. Food and Drug Administration) has approved elotuzumab in combination with
lenalidomide as a treatment option for this disease.
In this research study, the participant will receive pomalidomide which is an
immunomodulatory drug. This means that pomalidomide modulates the immune system to help fight
the disease. The FDA has approved pomalidomide as a treatment option for this disease after
receiving two other therapies.
Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other
chemotherapy for the treatment of blood cancers, such as myeloma and leukemias.
The FDA has not approved nivolumab for this specific disease but it has been approved for
other uses, specifically lung cancer. Nivolumab works by blocking an inhibitory signal within
immune cells, potentially allowing the immune system to fight the cancer.
In this research study the investigators are looking to see if the combination of elotuzumab,
nivolumab, pomalidomide, and dexamethasone is effective in fighting the cancer.
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