A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.
The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Lenalidomide and low-dose dexamethasone
- drug : Melphalan, Prednisone and Thalidomide
- drug : Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
Phase: Phase 3
Ages Eligible For Study:
1. Must understand and voluntarily sign informed consent form 2. Age ? 18 years at the time of signing consent 3. Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: - MM diagnostic criteria (all 3 required): - Monoclonal plasma cells in the bone marrow ?10% and/or presence of a biopsy-proven plasmacytoma - Monoclonal protein present in the serum and/or urine - Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis AND have measurable disease by protein electrophoresis analyses as defined by the following: - IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ? 1.0 g/dl or urine M-protein level ? 200 mg/24 hours - IgA multiple myeloma: Serum M-protein level ? 0.5 g/dl or urine M-protein level ? 200 mg/24 hours - IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ? 1.0 g/dl or urine M-protein level ? 200mg/24hours - IgD multiple myeloma: Serum M-protein level ? 0.05 g/dl or urine M-protein level ? 200 mg/24 hours - Light chain multiple myeloma: Serum M-protein level ? 1.0 g/dl or urine M-protein level ? 200 mg/24 hours AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because: - The patient declines to undergo stem cell transplantation or - Stem cell transplantation is not available to the patient due to cost or other reasons 4. ECOG performance status of 0, 1, or 2 5. Able to adhere to the study visit schedule and other protocol requirements 6. Females of child-bearing potential (FCBP)^2: 1. Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence. 2. Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy. 7. Male Patients: 1. Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy. 2. Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy. 3. Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy. 8. All patients must: 1. Have an understanding that the study drug could have a potential teratogenic risk. 2. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. 3. Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure.