A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Myeloma

In brief

To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma

Key facts

Study ID

NCT00057564

Run by

Celgene Corporation

People needed

470

Starts

2003-02-01

Expected to finish

2013-08-01

Last updated by the study team

2015-09-11

Who can join

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

You may qualify if…

• Active Multiple Myeloma Stage II or III Durie Salmon
• Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g excreted in a 24-hour collection sample)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
• Women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm)
• Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity

You may not qualify if…

• Pregnant or lactating females
• Peripheral neuropathy ≥ to grade 2 of the NCI CTC.
• Prior history of malignancy unless subject has been free of disease for ≥ 3 years
• Lab abnormality: Absolute neutrophil count (ANC) <1,000 cells/mm\^3 (1.0 x 10\^9/L)
• Lab abnormality: Platelet count <50,000/mm\^3 (50.0 x 10\^9/L)
• Lab abnormality: Serum creatinine >3.0 mg/dL (265 µmol/L)
• Lab abnormality: Serum glutamic oxaloacetic transaminase (SGOT) /Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine transaminase (ALT) >3.0 x upper limit of normal (ULN)
• Lab abnormality: Serum total bilirubin > 2.0 mg/dL (34 µmol/L)

Where it is running

• Arizona Clinical Research Center — Tucson, Arizona, United States
• UCLA School of Medicine — Los Angeles, California, United States
• James Berenson — West Hollywood, California, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Melbourne Internal Medicine Associates Oncology — Melbourne, Florida, United States
• Jackson Memorial Hospital and Clinics — Miami, Florida, United States
• University of Miami Miller School/Jackson Memorial Hospital — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Oncology Hematology Group of South Florida — Miami, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Southern Illinois Hematology /Oncology — Centralia, Illinois, United States
• Rush Cancer Institute Section of Hematology — Chicago, Illinois, United States
• University of Iowa Hospital of Clinic — Iowa City, Iowa, United States
• Ocshner Clinic Foundation — New Orleans, Louisiana, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Hackensack University Hospital — Hackensack, New Jersey, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• Cleveland Clinic- Taussig Cancer Center — Cleveland, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• South Carolina Oncology Group — West Columbia, South Carolina, United States
• The Family Centre, PLLC — Collierville, Tennessee, United States
• East Tennessee Oncology/Hematology Associates — Knoxville, Tennessee, United States
• Clinical Research Consultants, Inc. — Hoover, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.