Multiple Myeloma Clinical Trial
Official title:
Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression After Conditioning With Fludarabine and Low-Dose Total Body Irradiation for Recipients of HLA-Matched Family Donor Hematopoietic Cell Transplants
Primary Objective:
A. To determine whether stable allogeneic hematopoietic engraftment can be safely
established in patients receiving a non-myeloablative allogeneic SCT from a matched sibling
donor, with fludarabine and low-dose TBI, with pre- and post-transplant immunosuppression
with tacrolimus and MMF.
B. To evaluate the incidence of grade II-IV GVHD associated with this treatment.
Conditioning regimen:
1. Days - 4 to -2: Fludarabine 30 mg/m2/day IV.
2. Day 0: TBI 2.0 Gy at 6-7 cGy/min from a linear accelerator, followed by stem-cell
infusion. TBI will preferably be administered between 7:00 a.m. and 1:00 p.m. to avoid
proximity to tacrolimus/MMF administration.
Immunosuppression:
Day -3: Start tacrolimus at 0.06 mg/kg PO BID. Day 0: Start MMF at 15 mg/kg PO b.i.d. from
day 0 (PM dose only).
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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