A Phase 1 interventional study of bortezomib in Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Barbara Ann Karmanos Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-19.
Sponsored by Barbara Ann Karmanos Cancer Institute · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 15 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Must have completed high-dose melphalan and autologous peripheral blood stem cell transplantation
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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.
Drug: bortezomib
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
Also known as: 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
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Barbara Ann Karmanos Cancer Institute