A Phase II Study of High Dose Late Intensification Therapy in Patients With Chemotherapy Sensitive Multiple Myeloma
OBJECTIVES: I. Determine the feasibility and activity of intensive therapy with 3 noncross
resistant chemotherapeutic regimens (cyclophosphamide, etoposide, cisplatin, cytarabine, and
tandem courses of high dose melphalan with stem cell rescue) in patients with chemotherapy
sensitive multiple myeloma. II. Determine the incidence of hematologic and nonhematologic
toxicities of this regimen in this patient population. III. Determine the time to
hematologic recovery after high dose melphalan in these patients. IV. Determine the response
rate after each course of therapy in these patients. V. Determine the disease free, relapse
free, and overall survival of these patients treated on this regimen. VI. Determine the
incidence of toxicities attributable to interferon alfa and the ability to continue
interferon alfa therapy as maintenance in these patients.
OUTLINE: Patients are stratified according to the number of prior treatments (1 vs 2).
Patients receive cyclophosphamide IV over 1 hour every 3 hours for 5 doses. Filgrastim
(G-CSF) is administered subcutaneously daily beginning 3 days after cyclophosphamide and
continuing through apheresis. Upon hematologic recovery, peripheral blood stem cells (PBSC)
are collected over several days. After completion of the autologous stem cell harvest and
hematologic recovery, patients receive etoposide IV and cisplatin IV continuously over 4
days, followed by cytarabine IV over 2 hours. Beginning 4-6 weeks later, patients receive
melphalan IV over 15 minutes on 2 consecutive days. At least 48 hours after the second dose
of melphalan, PBSC are reinfused. G-CSF is administered subcutaneously daily beginning 5
days after PBSC reinfusion until hematologic recovery. Patients remaining in remission after
the first course of high dose melphalan receive a second course of melphalan 4 to 6 months
after the first course. Melphalan IV is administered as above with reinfusion of the
remainder of PBSC. After hematologic recovery from the second transplant, patients receive
interferon alfa subcutaneously 3 days weekly until relapse. Patients are followed every 2
months.
PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study within 3 years.
Interventional
Primary Purpose: Treatment
Jane N. Winter, MD
Study Chair
Robert H. Lurie Cancer Center
United States: Federal Government
CDR0000067582
NCT00004903
October 1999
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |