CI-994 in Treating Patients With Advanced Myeloma
- Registration Number
- NCT00005624
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CI-994 Treatment CI-994 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.
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) 5 years Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Secondary Outcome Measures
Name Time Method Number of Participants with Overall Survival (OS) 5 years Participants surviving at end of study.
Duration of Response 5 years Response of duration in months
Number of Participants with Adverse Events 5 years Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.
Trial Locations
- Locations (1)
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States