Eligibility NCT00689936 Multiple Myeloma Inclusion Criteria Must understand and voluntarily sign informed consent form Yes
No
Age ≥ 18 years at the time of signing consent Yes
No
Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: Yes
No
MM diagnostic criteria (all 3 required) Yes
No
Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma Yes
No
Monoclonal protein present in the serum and/or urine Yes
No
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 Yes
No
AND have measurable disease by protein electrophoresis analyses as defined by the following Yes
No
IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours Yes
No
IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours Yes
No
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 Yes
No
IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours Yes
No
Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours Yes
No
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 Yes
No
The patient declines to undergo stem cell transplantation or Yes
No
Stem cell transplantation is not available to the patient due to cost or other reasons Yes
No
ECOG performance status finding <= 2 Yes
No
Able to adhere to the study visit schedule and other protocol requirements Yes
No
Females of child-bearing potential (FCBP)^2 Yes
No
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. Yes
No
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. Yes
No
male, male gender Yes
No
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. Yes
No
Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy Yes
No
All patients must Yes
No
Have an understanding that the study drug could have a potential teratogenic risk Yes
No
Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. Yes
No
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 Yes
No
Exclusion Criteria Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., <= 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]). Yes
No
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. Yes
No
Pregnant or lactating females Yes
No
Any of the following laboratory abnormalities Yes
No
Absolute Neutrophil Count Yes
No
Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L) Yes
No
Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) Yes
No
Renal failure requiring hemodialysis or peritoneal dialysis. Yes
No
Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following: Yes
No
Basal cell carcinoma Yes
No
Spinous cell carcinoma Yes
No
Carcinoma in situ of uterine cervix Yes
No
Stage 0 Breast Carcinoma Yes
No
Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) Yes
No
Patients who are unable or unwilling to undergo antithrombotic therapy. Yes
No
Peripheral neuropathy of > grade 2 severity. Yes
No
Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis. Yes
No
A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related. Yes
No
A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Yes
No
