Description:

ODM derived from http://clinicaltrials.gov/show/NCT00689936

Link:

http://clinicaltrials.gov/show/NCT00689936

Keywords:
Versions (2) ▾
  1. 12/9/13
  2. 4/16/14
Uploaded on:

April 16, 2014

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Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00689936 Multiple Myeloma

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
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:
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
ECOG performance status finding <= 2
Able to adhere to the study visit schedule and other protocol requirements
Females of child-bearing potential (FCBP)^2
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.
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.
male, male gender
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.
Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy
All patients must
Have an understanding that the study drug could have a potential teratogenic risk
Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
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
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]).
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
Absolute Neutrophil Count
Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L)
Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
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:
Basal cell carcinoma
Spinous cell carcinoma
Carcinoma in situ of uterine cervix
Stage 0 Breast Carcinoma
Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
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.
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.
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).