Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Mayo Clinic
With
OBJECTIVES: Primary * Determine the maximum tolerated dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium in patients with recurrent or refractory multiple myeloma. (Phase I) * Determine the safety and tolerability of this regimen in these patients. (Phase II) * Determine the hematologic response rate in patients treated with this regimen. (Phase II) Secondary * Determine the rate of serum immunoglobulin light chain reduction in patients treated with this regimen. * Assess the in vivo toxicity of this regimen to the progenitor cells by measuring complete blood cell count and micronucleated reticulocyte count in these patients. OUTLINE: This is a phase I, pilot, open-label, dose-escalation study of bortezomib followed by a phase II study. * Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on day 1 and bortezomib IV over 3-5 seconds on days 2 and 5. Cohorts of 3-6 patients receive escalating doses of bortezomib 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. * Phase II: Patients receive samarium Sm 153 lexidronam pentasodium as in phase I and bortezomib at the MTD determined in phase I . Patients undergo blood sample collection at baseline and then on days 1-6 for correlative studies. Samples are analyzed for micronucleated reticulocyte count and immunoglobulin free light chain ratio to determine the early effects of treatment. After completion of study treatment, patients are followed weekly for 7 weeks, monthly for 3 months and then every 3 months for a total of 3 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
