A Phase I/II Study of a Novel Reduced Intensity Conditioning Regimen for Allogeneic Stem Cell Transplantation in Patients With Multiple Myeloma
Objectives:
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
multiple myeloma.
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.
Interventional
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)
Yes
Martha Q. Lacy, M.D.
Study Chair
Mayo Clinic
United States: Food and Drug Administration
MC078F
NCT00995059
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