Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
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.
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in
chemotherapy use different ways to stop cancer cells from dividing so they stop growing or
die. Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, busulfan, and
interferon alfa followed by peripheral stem cell or bone marrow transplantation in treating
patients with 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
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