NCT02441686

Phase II Study of Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib and Dexamethasone Therapy for Newly Diagnosed Multiple Myeloma

A Phase II Study of the Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 therapy.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bortezomib
DRUG	Lenalidomide
DRUG	Dexamethasone
PROCEDURE	Stem Cell Mobilization
PROCEDURE	Autologous Stem Cell Transplant

Timeline

• Start date: 2015-12-01
• Primary completion: 2021-12-01
• Completion: 2025-10-01
• First posted: 2015-05-12
• Last updated: 2026-01-13
• Results posted: 2024-03-04

Locations

8 sites across 1 country: United States