NCT00021359

Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma

A Phase II Trial of Dexamethasone and 13-cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with dexamethasone may be an effective treatment for multiple myeloma. PURPOSE: Phase II trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma.

Detailed description

OBJECTIVES: I. Determine the response rate and duration of response of patients with multiple myeloma treated with dexamethasone and isotretinoin. II. Determine the toxicity of this regimen in these patients. III. Correlate the changes in serum interleukin (IL)-6, IL-6R, and C-reactive and IL-6R expression on plasma cells in the bone marrow with response in patients treated with this regimen. OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral isotretinoin daily. Treatment repeats every 5 weeks for at least 2 courses in the absence of disease progression, insufficient response, or unacceptable toxicity. Patients achieving adequate response continue treatment for 2 courses after achieving a plateau of monoclonal protein, for a minimum of 6 courses total. PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 3 years.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	dexamethasone
DRUG	isotretinoin

Timeline

• Start date: 1999-08-01
• Primary completion: 2000-07-01
• Completion: 2005-10-01
• First posted: 2004-03-11
• Last updated: 2013-07-10

Locations

18 sites across 1 country: United States