Phase II Study of Simvastatin in Waldenstrom's Macroglobulinemia
- Treatment in this study involves starting at a reduced dose for the first week, and
moves up in dose each week for the following three weeks. At which time the
participant will continue to take the same dose daily. The study drug is taken orally
once a day in the morning.
- If participants have no major side effects, they will continue on the maximal dose for
2 years. If they experience major side effects, then the dose of the drug might be
lowered or the drug stopped. The study drug will continue until the participants
disease gets worse.
- During the treatment period participants will come in for routine visits to have a
physical exam and laboratory tests. CT scans of the chest, abdomen and pelvis and bone
marrow aspirate and biopsy may also be performed.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To define objective response (ORR, CR, PT, MR), time to progression (TTP) and safety of simvastatin therapy in patients with slow progressing Waldenstrom's macroglobulinemia.
Steven Treon, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|