Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00689936

Run by

Celgene

People needed

1623

Starts

2008-08-21

Expected to finish

2016-07-14

Last updated by the study team

2019-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 of 0, 1, or 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 Patients:
• 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.
• 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.

You may not qualify if…

• 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:
• Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L)
• 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 of the skin
• Squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• 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.
• 1 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.
• 2 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).

Where it is running

• Cedar Sinai Medical Center Dept of Medicine — Los Angeles, California, United States
• University of California, San Francisco- California — San Francisco, California, United States
• Stanford University Stanford — Stanford, California, United States
• Gainesville Heme Oncology Associates — Gainesville, Florida, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• Integrated Community Oncology Network — Orange Park, Florida, United States
• Gulf Coast Oncology — St. Petersburg, Florida, United States
• Palm Beach Cancer Institute, LLC — West Palm Beach, Florida, United States
• Southern Illinois Hematology Oncology — Centralia, Illinois, United States
• Orchard Healthcare Research, Inc. — Chicago, Illinois, United States
• John H Stroger Hospital of Cook County — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Ingalls Cancer Institute — Harvey, Illinois, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Maine Center for Cancer Medicine Blood Disorders — Scarborough, Maine, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Billings Clinic — Billings, Montana, United States
• Arena Oncology Associates, PC — Lake Success, New York, United States
• Dakota Cancer Institute — Fargo, North Dakota, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Kaiser Permanente Northwest Oncology Hematology — Portland, Oregon, United States
• University of AL Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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