Phase I/II Trial of Bortezomib (Velcade) in Addition to Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease After Mismatched Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation
- In this study we are looking for the highest dose of Velcade that can be given to
people safely when given with tacrolimus and methotrexate. Not everyone who
participates in the study will receive the same amount of the study drug. The dose the
participant will receive depends upon the number of subjects enrolled on the study and
how well they have tolerated their doses of the drug.
- Before Transplant: In addition to the chemotherapy drugs, fludarabine and busulfex,
for the participants non-myeloablative transplant, they will also start taking
tacrolimus orally three days before their transplant.
- After Transplant Medication: Methotrexate; Intravenously on days 1, 3, 6 & 11 after
transplant for a total of 4 doses. Tacrolimus; Continue taking orally once daily.
Velcade: Intravenously on days 1, 4 & 7 after transplant, a total of 3 doses.
Filgrastim: Subcutaneous injection daily starting the day after transplant and
continuing until the participant blood counts have recovered.
- After Transplant Physical Exams & Tests: Participants will have physical exams and
blood tests every week for 1 month. After 1 month, a none marrow biopsy will be
performed to look for evidence of the donor's cells in the participants bone marrow.
- Following the 1 month period of time, participants will be seen every few weeks.
Another bone marrow biopsy, as well as blood tests, will be taken 3-4 months after the
transplant to review the disease status. At this point, participants will come into
the clinic about every 3 months, or as determined by their physician for about one
- While the study ends at 12 months after transplant, we would like to keep track of the
participants medical condition for the rest of their life.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
To establish the maximally tolerated dose of Velcade that can be administered with Tacrolimus and Methotrexate after mismatched allogeneic non-myeloablative peripheral blood stem cell (PBSC) transplantation
by day 45 post PBSC infusion
John Koreth, MD
Dana-Farber Cance Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|