RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CI-994 in treating patients who have advanced myeloma.
OBJECTIVES: I. Determine the antitumor activity of CI-994 in patients with advanced myeloma. II. Determine the response rate, response duration, and overall survival of this patient population with this treatment regimen. III. Determine the safety of this treatment in these patients. OUTLINE: This is a multicenter study. Patients receive CI-994 orally daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days and then every 2 months. PROJECTED ACCRUAL: A total of 8-63 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
CI-994 as outlined in treatment arm.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Overall Response Rate (ORR)
Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Time frame: 5 years
Duration of Response
Response of duration in months
Time frame: 5 years
Number of Participants with Overall Survival (OS)
Participants surviving at end of study.
Time frame: 5 years
Number of Participants with Adverse Events
Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.
Time frame: 5 years
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