Bortezomib in Treating Patients With Multiple Myeloma Who Have Undergone an Autologous Peripheral Blood Stem Cell Transplant
|ClinicalTrials.gov Identifier: NCT00288028|
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : November 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: bortezomib||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||June 2012|
U.S. FDA Resources
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®
- Maximum tolerated dose [ Time Frame: At course 8 ]
- Safety and tolerability [ Time Frame: At course 8 ]
- 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 ]
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|