A Phase II Trial If Nivolumab Lenalidomide and Dexamethasone in High Risk Smoldering Myeloma
Brief description of study
This research study is evaluating a new drug called "nivolumab" as a possible treatment for
smoldering multiple myeloma in order to prevent or postpone development of active multiple
- Patients with smoldering multiple myeloma do not have symptoms but are at risk for
progressing to active multiple myeloma. Multiple myeloma is a cancer of the plasma cell,
which is an important part of the immune system. Patients with active multiple myeloma
generally require treatment.
Clinical Study Identifier: NCT02903381
Detailed Study Description
- This research study is a Phase II clinical trial, which tests the effectiveness of an
investigational drug(s). The investigational drugs used in this research study are;
- Preliminary experience suggests that the combination of lenalidomide and dexamethasone
may prevent or postpone smoldering multiple myeloma (SMM) from becoming active multiple
myeloma. The purpose of this research study is to determine if the addition of
nivolumab may improve the rate of prevention in combination with lenalidomide and
- "Investigational" means that the FDA (the U.S. Food and Drug Administration) has not
approved the combination of nivolumab, lenalidomide and dexamethasone as a treatment
- Lenalidomide is an immunomodulatory drug derived from thalidomide. Lenalidomide works
by stopping blood flow to your cancer cells and signaling your cancer cells to die off.
The FDA has approved lenalidomide for the treatment of many types of cancer including
multiple myeloma, and myelodysplastic syndromes.
- 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.
- Nivolumab is approved by the FDA for some lung cancers, some skin cancers, some kidney
cancers, and Hodgkin lymphoma. It is currently being evaluated for use in the treatment
of several other types of cancers. Nivolumab may kill or stop cancer cells from growing
by blocking a signal in the cells allowing the immune system to fight the cancer. This
drug is a human monoclonal antibody, which is a molecule that is made in a laboratory
that is designed to act identically to cells in the immune system.