Bortezomib in Treating Patients With Multiple Myeloma Who Have Undergone an Autologous Peripheral Blood Stem Cell Transplant
- Registration Number
- NCT00288028
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib after an autologous peripheral blood stem cell transplant may stop the growth of any cancer cells that remain after transplant.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib in treating patients with multiple myeloma who have undergone an autologous peripheral blood stem cell transplant.
- Detailed Description
OBJECTIVES:
Primary
* Determine the maximum tolerated dose (MTD) of bortezomib during maintenance phase after high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
* Determine the safety and tolerability of bortezomib in these patients.
Secondary
* Determine the overall response rate, complete response rate, and response duration in patients treated with bortezomib at the MTD.
OUTLINE: This is an open-label, dose-finding study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 or 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive de-escalating doses of bortezomib (at varying dosing schedules) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed at 1 year.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bortezomib bortezomib Bortezomib is administered as a 5 second IV bolus on days 1, 4, 8,11 or 1,8 and 15 of a 21-35 days cycle (Depending on the Dosing schedule). The dosage will be calculated based on actual weight of the patient unless the actual weight is greater than 40% above the ideal body weight. In this instance the dosage will be based on the adjusted ideal body weight. The Adjusted IBW (kg) = IBW + 0.25 x (actual body weight - IBW). The dosage will be adjusted based on the safety and toxicity profile, until a MTD is determined.
- Primary Outcome Measures
Name Time Method Maximum tolerated dose At course 8 Safety and tolerability At course 8
- Secondary Outcome Measures
Name Time Method Complete response rate by SWOG criteria At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment Overall response rate by Southwest Oncology Group (SWOG) criteria At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment Response duration by SWOG criteria At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
Trial Locations
- Locations (1)
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States