Phase II Study of Efficacy and Safety of Lenalidomide Subcutaneous Bortezomib and Dexamethasone Therapy for Newly Diagnosed Multiple Myeloma
Brief description of study
This research study is evaluating a combination of three drugs called lenalidomide,
subcutaneous (injection under the skin) bortezomib, and dexamethasone (RVD) as a possible
treatment for multiple myeloma.
Clinical Study Identifier: NCT02441686
Detailed Study Description
This research study is a Phase II clinical trial, which tests the safety and effectiveness
of an investigational combination of drugs to learn whether the combination of drugs works
in treating a specific cancer. "Investigational" means that the combination of drugs is
being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not
yet approved the combination of drugs for your type of cancer.
Each of the individual drugs, lenalidomide , subcutaneous bortezomib, and dexamethasone, are
approved by the U.S. Food and Drug Administration (FDA). The combination has not been
approved yet for multiple myeloma or any other type of cancer. Subcutaneous bortezomib is
currently approved by the U.S. FDA for the treatment of patients with relapsed/refractory
multiple myeloma. Lenalidomide is currently approved for use with dexamethasone for patients
with multiple myeloma who have received at least one prior therapy and for the treatment of
certain types of myelodysplastic syndrome (another form of cancer affecting the blood). Both
Bortezomib and Lenalidomide kill tumor cells and help the body cells to fight cancer.
Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat
multiple myeloma. Dexamethasone heps to reduce irritation and cell injury (inflammation).
In this research study, the investigators are looking to explore the drug combination of
lenalidomide, subcutaneous bortezomib and dexamethasone to see what side effects it may have
and how well it works for treatment of newly diagnosed multiple myeloma. This 3 drug regimen
showed promising results in previous studies, however administration of intravenous
bortezomib caused high levels of nerve injury (a condition involving the nerves of the upper
and lower extremities associated with numbness, tingling and burning). In this study, the
investigators are testing the hypothesis that subcutaneous administration of bortezomib will
result in less nerve toxicity. Therefore, the combination of lenalidomide, dexamethasone and
subcutaneous bortezomib may be better tolerated and may allow for a longer duration of