A Phase I Study of 90Y-BC8-DOTA Monoclonal Antibody, Fludarabine and TBI Followed by HLA-Matched, Allogeneic Peripheral Blood Stem Cell Transplant for the Treatment of Multiple Myeloma
I. To assess the tissue localization of 111In-BC8-DOTA antibody therapy (Ab) and establish
reproducibly favorable biodistributions.
II. To estimate the maximum tolerated dose (MTD) of radiation delivered via 90Y-BC8-DOTA Ab
when combined with fludarabine phosphate (FLU) and 2 Gy total-body irradiation (TBI) as a
preparative regimen followed by human leukocyte antigen (HLA)-matched, related or unrelated
hematopoietic cell transplant (HCT) for patients with multiple myeloma.
I. To assess the potential efficacy of this approach, within the limits of a phase I study,
by examining disease response, duration of remission, disease free survival (DFS), and
overall survival (OS).
OUTLINE: This is a dose-escalation study of yttrium Y 90 anti-CD45 monoclonal antibody BC8
Patients receive 90Y-BC8 Ab intravenously (IV) on day -12 and fludarabine phosphate IV on
days -4 to -2. Patients undergo TBI and allogeneic peripheral blood stem cell transplant on
day 0. Patients also receive graft-vs-host disease prophylaxis comprising cyclosporine
orally (PO) twice daily (BID) on days -3 to 56 with taper to day 180 or on days -3 to 100
with taper to 180; and mycophenolate mofetil IV or PO BID on days 0-27, or 0-40 with taper
After completion of study treatment patients are followed up every 6 months for 2 years and
then annually thereafter.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of the tissue localization of 111In-BC8-DOTA Ab to establish reproducibly favorable biodistributions
Up to 72 hours post infusion
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|