A Phase II Study of Total Marrow Irradiation, Busulfan, and Alpha-Interferon Followed by Allogeneic Peripheral Blood Stem Cell or Marrow Transplantation for Treatment of Patients With Advanced Multiple Myeloma.
OBJECTIVES: I. Evaluate the effects of total marrow irradiation and busulfan followed by
allogeneic peripheral blood stem cell or marrow transplantation on the outcomes of treatment
related mortality, response, relapse, survival, and event free survival for patients with
advanced multiple myeloma.
OUTLINE: Peripheral blood stem cell (PBSC) or bone marrow (BM) collection and infusion are
performed according to standard practice. Patients undergo total marrow irradiation (TMI)
bid for 3 days. Busulfan is administered every 6 hours on days -6 to -3. PBSC or BM is
infused on day 0. Interferon alfa is administered subcutaneously on Mondays, Wednesdays, and
Fridays beginning on day 80. Interferon therapy may continue in the absence of graft versus
host disease or disease progression. Patients are followed on days 56 and 84, then every 6
months for 2 years, and annually thereafter.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued over 3 years.
Primary Purpose: Treatment
William I. Bensinger, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|