Bortezomib in Treating Patients With Multiple Myeloma Who Have Undergone an Autologous Peripheral Blood Stem Cell Transplant
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Bortezomib During Maintenance Phase After High Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma|
- Maximum tolerated dose [ Time Frame: At course 8 ] [ Designated as safety issue: Yes ]
- Safety and tolerability [ Time Frame: At course 8 ] [ Designated as safety issue: Yes ]
- Overall response rate by Southwest Oncology Group (SWOG) criteria [ Time Frame: At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment ] [ Designated as safety issue: No ]
- Complete response rate by SWOG criteria [ Time Frame: At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment ] [ Designated as safety issue: No ]
- Response duration by SWOG criteria [ Time Frame: At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||June 2012|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
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.
Dose of Bortezomib* Level 1: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 21 days; Level 2: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 28 days; Level 3: 1.0 mg/m2 on Day 1, 8, 15 - Every 28 days; Level 4: 1.0 mg/m2 on Day 1, 8, 15 - Every 35 days
Other Name: Velcade®
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288028
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Muneer H. Abidi, MD||Barbara Ann Karmanos Cancer Institute|