A Phase I/II Study of a Novel Reduced Intensity Conditioning Regimen for Allogeneic Stem Cell Transplantation in Patients With Multiple Myeloma
I. To determine the maximum tolerated dose (MTD) of bortezomib when used in a novel
conditioning regimen for patients undergoing allogeneic stem cell transplantation for
II. To evaluate the tolerability and feasibility of this novel conditioning regimen and GVHD
prophylaxis strategy incorporating several anti-myeloma agents, including bortezomib, in
patients undergoing allogeneic stem cell transplantation for multiple myeloma.
III. To obtain an initial assessment of the efficacy of this novel conditioning regimen.
Outline: This is a phase I dose-escalation study of bortezomib followed by a phase II study.
Reduced-Intensity Conditioning: Patients receive bortezomib IV and then undergo fractionated
total-body irradiation on days -5 and -2. Patients receive thymoglobulin IV over 6 hours on
days -5 to -2 and melphalan IV over 30 minutes on days -4 to -3.
Allogenic Stem Cell Transplantation: Patients undergo bone marrow or peripheral blood stem
cell transplant on day 0.
Graft versus Host Disease Prophylaxis: Beginning on day -3, patients receive oral sirolimus
and taper beginning on day 61. Beginning on day -2, patients receive oral or IV tacrolimus
and taper beginning on day 101. After completion of the study treatment, patients are
followed every 3 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerability as assessed by CTCAE v3.0 (Phase I)
Martha Q. Lacy, M.D.
United States: Food and Drug Administration