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.
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.
CC-5013-MM020/IFM 07-01 is a Phase III, multicenter, randomized, open-label, 3-arm study that will compare the efficacy and safety of two Lenalidomide plus low-dose dexamethasone regimens given for two different durations of time (i.e., until progressive disease [PD] or for up to a maximum of 18 four-week cycles) to that of MPT given for a maximum of 12 six-week cycles.
Inclusion Criteria:
Must understand and voluntarily sign informed consent form
Age ≥ 18 years at the time of signing consent
Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:
AND have measurable disease by protein electrophoresis analyses as defined by the following:
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:
ECOG performance status of 0, 1, or 2
Able to adhere to the study visit schedule and other protocol requirements
Females of child-bearing potential (FCBP)^2:
Male Patients:
All patients must:
Exclusion Criteria:
Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
Pregnant or lactating females.
Any of the following laboratory abnormalities:
Renal failure requiring hemodialysis or peritoneal dialysis.
Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
Patients who are unable or unwilling to undergo antithrombotic therapy.
Peripheral neuropathy of > grade 2 severity.
Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
East Melbourne, Victoria 3002, Australia
Salzburg, 5020, Austria
Tianjin, 300041, China
Bordeaux, 33076, France
Chalon/Saone Cedex, 71321, France
Roma, 00144, Italy
Hwasun-goon, 519-803, South Korea
Seongsanno, 120-752, South Korea
Tapei, 10002, Taiwan
Belfast Northern Ireland, BT9 7AB, United Kingdom
Birmingham West Midlands, B15 2TH, United Kingdom
Bournemouth Dorset, BH7 7DW, United Kingdom
Plymouth Crownhill Devon, PL6 8DH, United Kingdom
West Yorkshire, WF1 4DG, United Kingdom