39
Participants
Start Date
December 3, 2008
Primary Completion Date
March 22, 2011
Study Completion Date
June 27, 2018
dexamethasone
"Dose: -40 mg once weekly (days 1, 8, 15, \& 22) orally with food until progression.~If after 3 cycles, a partial response is not achieved on lenalidomide alone, dexamethasone 10 mg weekly will be added, and the weekly dexamethasone dose will be increased by 10 mg each cycle to a maximum of 40 mg weekly, as long as a partial response is not achieved. If a partial response is achieved at a dose of dexamethasone less than 40 mg weekly, patients will continue on that dose. If progression at any time, increase dexamethasone to 40 mg weekly. Patient will go off study only when progression is documented while receiving 40 mg/week of dexamethasone or the maximum tolerated dose of dexamethasone (if prior dose reductions have been implemented for toxicity). Increases in dexamethasone dose are to be made only at the initiation of a cycle.~If progression at any time while on lenalidomide alone (first 3 cycles), add dexamethasone 40 mg weekly."
lenalidomide
"25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.~Lenalidomide alone will be administered for the first 3 cycles, then in combination with dexamethasone as needed (described)."
Mayo Clinic, Rochester
Lead Sponsor
National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER