Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

December 3, 2008

Primary Completion Date

March 22, 2011

Study Completion Date

June 27, 2018

Conditions
Multiple Myeloma and Plasma Cell Neoplasm
Interventions
DRUG

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."

DRUG

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)."

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Mayo Clinic

OTHER

NCT00772915 - Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma | Biotech Hunter | Biotech Hunter