||UARK 2009-09 – Myeloma Cure Project: Prospective, Randomized Trial of Indefinite Revlimid® Maintenance versus Observation for Currently Event-Free Patients with Multiple Myeloma (MM) Who Have Completed 3 Years of VTD/TD or VTD or VRD Maintenance on Total Therapy 3 (TT3)
Trials 2003-33 and 2006-66
||Bart Barlogie, MD
||To determine, in a phase III trial, whether further maintenance therapy with Revlimid (REV, 10 mg/d) can extend the duration of progression-free survival (PFS) and the duration of complete or near-complete response (CR, n-CR) compared to no further therapy (NFT) beyond the TT3 Protocol prescribed 3 years of maintenance with 1 year of VTD plus 2 years with TD (n=276), 3 years with VTD (2003-33) or 3 years with VRD (2006-66).
||Male and female participants of all races/ethnicities with multiple myeloma previously enrolled on UARK 2003-33 or 2006-66.
Three hundred research participants, male or female, age 18 and older, regardless of race or ethnicity, will take part in this study at the Myeloma Institute for Research and Therapy (MIRT).
||The dosing regimen will consist of 10 mg/day. After disease assessment and signing a written informed consent, eligible participants will be randomized to receive Revlimid® (lenalidomide) at 10mg/day versus observation. Revlimid® (lenalidomide) will be taken continuously until disease recurrence or untoward toxicity development.
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