NCT00049374

Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	oblimersen sodium
DRUG	dexamethasone
DRUG	thalidomide

Timeline

• Start date: 2002-09-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2003-01-27
• Last updated: 2019-10-17

Locations

2 sites across 1 country: United States