Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
RATIONALE: Thalidomide may slow the growth of cancer cells. Oblimersen may increase the effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the drugs.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and dexamethasone with oblimersen in treating patients who have relapsed or refractory multiple myeloma.
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: oblimersen sodium Drug: dexamethasone Drug: thalidomide||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma|
- Complete and partial remission
- Relationship between molecular and clinical outcomes
|Study Start Date:||September 2002|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
- Determine the clinical efficacy of oblimersen, thalidomide, and dexamethasone, in terms of complete and partial response rates, in patients with relapsed or refractory multiple myeloma.
- Determine the time to progression and duration of response in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate disease response (clinical outcome) with changes in Bcl-2 levels in patients treated with this regimen.
- Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive induction therapy comprising oblimersen IV continuously on days 1-7, 22-28, and 43-49, oral dexamethasone on days 4-7, 25-28, and 46-49, and oral thalidomide daily beginning on day 4. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients with stable disease after induction therapy receive maintenance therapy comprising oblimersen IV continuously on days 1-7, oral dexamethasone on days 4-7, and oral thalidomide daily. Courses repeat every 35 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 10-46 patients will be accrued for this study within 10 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049374
|United States, Maryland|
|Greenebaum Cancer Center at University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201-1592|
|United States, New York|
|St. Vincent's Comprehensive Cancer Center - Manhattan|
|New York, New York, United States, 10011|
|Study Chair:||Ashraf Z. Badros, MD||University of Maryland Greenebaum Cancer Center|