Multiple Myeloma Clinical Trial
Official title:
A Phase I/II Trial of Cyclophosphamide, Carfilzomib, Thalidomide and Dexamethasone (CYCLONE) in Patients With Newly Diagnosed Active Multiple Myeloma
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in
different ways to stop the growth of cancer cells, either by killing the cells or by stopping
them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the
enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking
blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and
thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when
given together with cyclophosphamide, thalidomide, and dexamethasone in treating patients
with newly diagnosed active multiple myeloma.
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.
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