A Randomized Phase II Trial of Fludarabine/Melphalan 140 VS. Fludarabine/Melphalan 100 Followed By Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma
Fludarabine is a chemotherapy drug that is used in various diseases. Melphalan is a
chemotherapy drug that has been widely used in the treatment of multiple myeloma for many
Before beginning therapy, patients will have a complete work-up. This includes a bone
marrow aspiration and biopsy, bone survey, blood tests, and tests to check the heart and
lung function. All patients will receive tacrolimus and methotrexate to prevent
Patients in this study will be randomly picked (as in the toss of a coin) to be in one of
two treatment groups. There is an equal chance that a patient will be in either group.
Patients in the first group will receive fludarabine through the vein every day for four
days. On the fourth day, patients will receive a dose of melphalan through the vein over 20
minutes. On the following day, patients will receive the donor cells as an infusion through
Patients in the second group will receive fludarabine through the vein every day for four
days. Patients in this group will receive a lower dose of melphalan through the vein over
20 minutes. After the last dose of fludarabine, patients will receive the donor cells as an
infusion through their catheter the next day.
If you have an unrelated or a mismatched donor, you will receive the drug ATG
(Thymoglobulin) by vein over 6 hours on Days -3, -2, and -1 (the 3 days before the
transplant), to prevent graft versus host disease (GVHD) and to help engraftment.
Patients in both group will be receiving the monoclonal antibody called rituximab weekly
starting on the fifth day before the stem cell transplant for a total of 4 doses.
Patients will remain in the hospital for about 4-6 weeks and in Houston Medical Center area
at least 100 days after transplantation.
Patients whose disease gets worse will be taken off study. These patients will continue to
be followed for survival.
This is an investigational study. All of the drugs used in this study are commercially
available. The FDA has approved melphalan for the treatment of myeloma. Fludarabine is not
approved for the treatment of myeloma but has been used for years as a way to prepare
patients for transplant. About 30 to 60 patients will take part in this study. About 45
patients will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Successful Engraftment at Day 100
Treatment success (S100), defined as the event that the patient is alive, responding (50% reduction in the characterizing myeloma protein) and engrafted at day 100.
Muzaffar H. Qazilbash, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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