Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma
Location:
Rochester, Minn., Phoenix/Scottsdale, Ariz.
Trial status:
Open for Enrollment
Why is this study being done?
PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. (Phase I) II. In newly diagnosed myeloma to evaluate the response rate (CR, nCR, and VGPR) to carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone after four 28 day cycles. (Phase II)
SECONDARY OBJECTIVES:
I. Determine the overall response rate (CR, nCR, PR) after 4, 8, 12 cycles. II. Determine the duration of progression-free and overall survival for patients receiving this regimen.
III. To evaluate the incidence of toxicities for this regimen. IV. To evaluate the ability to successfully collect peripheral blood stem cells following four months of combination therapy.
OUTLINE: This is a phase I, dose escalation study of carfilzomib followed by a phase II study.
Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months, then every 3 months for 1 year, and then every 6 months for up to 3 years.
NCT ID:
NCT01057225
IRB Number:
09-004091
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