A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Drug: A (Thalidomide + Dexamethasone)Drug: B (Placebo + Dexamethasone)
- Registration Number
- NCT00057564
- Lead Sponsor
- Celgene Corporation
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 470
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A (Thalidomide & Dexamethasone) A (Thalidomide + Dexamethasone) Thalidomide 50mg/day + Dexamethasone 40mg B (Dexamethasone and placebo) B (Placebo + Dexamethasone) Dexamethasone and placebo
- Primary Outcome Measures
Name Time Method Time to tumor progression (TTP) Up to 3 years Time to tumor progression (TTP)
- Secondary Outcome Measures
Name Time Method Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone) Up to 3 years Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Myeloma response rate Up to 3 years Myeloma response determination criteria developed by Bladé et al 1998
Number of patients who survived Up to 3 years Number of patients who survived
Number of participants with adverse events Up to 3 years Number of participants with adverse events
Trial Locations
- Locations (98)
Clinical Research Consultants, Inc.
🇺🇸Hoover, Alabama, United States
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
Scroll for more (88 remaining)Clinical Research Consultants, Inc.🇺🇸Hoover, Alabama, United States