MC1082: A Phase I/II Trial of Pomalidomide (CC-4047), Bortezomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Rochester, Minn., Jacksonville, Fla., Phoenix/Scottsdale, Ariz.
Open for Enrollment
Why is this study being done?
I. Determine the maximum tolerated dose (MTD) of bortezomib in combination with pomalidomide and dexamethasone.
II. To evaluate the hematologic response rate (PR, VGPR, or CR) of pomalidomide, bortezomib and dexamethasone in patients with relapsed or refractory myeloma.
I. Time to progression.
II. To assess the toxicity of pomalidomide, bortezomib and dexamethasone in this patient population.
OUTLINE : This is a phase I, dose-escalation study of bortezomib followed by a phase II study. Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8,15, 22; and oral dexamethasone on days 1, 8, 15, 22 . Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.
Who can I contact for additional information about this study?
Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
Scottsdale: Mayo Clinic Clinical Trials Office 507-538-7623
Jacksonville: Mayo Clinic Clinical Trials Office 507-538-7623