Immunotherapy for Autologous/Syngeneic Peripheral Blood Stem Cell (PBSC) Transplant Patients as Treatment for Advanced Multiple Myeloma
PRIMARY OBJECTIVES:
I. Evaluate initial response to therapy, time to disease progression, and overall survival
in MM patients treated with melphalan, IL2- incubated peripheral blood stem cells, and
sequential IL2.
SECONDARY OBJECTIVES:
I. Evaluate grade 3-4 toxicities encountered by younger (< 56 years old) and older (>56
years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated
peripheral blood stem cells, and sequential IL2.
OUTLINE:
Patients receive melphalan intravenously (IV) over 2-3 hours on day -2 and an infusion of
IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day
0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment
with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance
therapy comprising interferon alfa subcutaneously (SC) 3 times a week in the absence of
disease progression or unacceptable toxicity.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
From baseline until disease progression, assessed up to 50 years
No
Leona Holmberg
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
1461.00
NCT00006244
February 2000
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |