A Phase I/II Trial of Cyclophosphamide, Carfilzomib, Thalidomide and Dexamethasone (CYCLONE) in Patients With Newly Diagnosed Active Multiple Myeloma
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)
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
OUTLINE: This is a phase I, dose escalation study of carfilzomib followed by a phase II
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (phase I)
From baseline to end of active treatment
Joseph R. Mikhael, M.D.
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|
|Mayo Clinic in Arizona||Scottsdale, Arizona 85259-5404|