A Phase II Study of Modified Lenalidomide, Bortezomib, and Dexamethasone for Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma
This research is being done to evaluate the combination of three drugs called Lenalidomide, Bortezomib, and Dexamethasone as a possible treatment for multiple myeloma. The purpose is to learn whether this combination of drugs works in treating a specific cancer. In this study, research doctors are looking at a different dosing schedule from what is normally given to patients with newly diagonsed multiple myeloma . Examples of what they want to learn about are the safest dose to use, the side effects it may cause, and if the combination of drugs works for treating your type of cancer.
Newly diagonsed multiple myeloma patients who are ineligible for transplant. Patients must be at least 14 days from any other investigational agent before starting the trial. No prior systemic therapy. Documented symptomatic myeloma.
The study will consist of two stages: induction and consolidation. The first nine cycles of treatment will be considered induction. During induction, each cycle of treatment will last 35 days. Participants will receive bortezomib at 1.3 mg/m2 i.v. or s.c.* on days 1, 8, 15, and 22. Lenalidomide will be given as a single daily oral dose of 15 mg on days 1-21 followed by 14-day rest period. For participants 75-years-old or younger, dexamethasone will be given at a dose of 20 mg po on Days 1, 2, 8, 9, 15, 16, 22, and 23. For participants over 75-years-old, dexamethasone 20 mg will begiven on Days 1, 8, 15, 22. *The first 10 participants will receive bortezomib i.v. for cycle 1 only; subsequent cycles will be given s.c.; subsequent participants will receive bortezomib s.c. throughout induction.
04/16/2014 04:02 AM