Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
A Phase II Trial of Dexamethasone and 13-cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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