Multiple Myeloma Clinical Trial
Official title:
Phase I/II Study of Myeloablative Allogeneic Stem Cell Transplantation for Aggressive Hematologic Malignancies Using Clofarabine and Busulfan x 4 (Clo/BU4) Regimen
The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with Busulfan as a full-intensity conditioning (Clo/BU4 regimen) prior to transplant and then (Phase II) to investigate the safety and effectiveness of this regimen as a conditioning for stem cell transplant in the treatment of aggressive hematologic malignancies in subjects where more conventional approaches are failing.
Transplants with stem cells collected from the blood of an unrelated donor (allo-HSCT) are
being used more commonly for many blood cancers which are not curable with more conventional
methods of chemotherapy. Although allo-HSCT has great potential, there are still high risks
due to infections, graft-versus-host disease (GVHD), where the donor's cells attack the
recipient's tissues as foreign, and due to toxic effects of the chemotherapy drugs given to
prepare (or condition) the recipient's bone marrow for transplant.
As a reduced intensity conditioning, a combination of Fludarabine and a lower dose of
Busulfan (Flu/BU2) is one of the most popular regimens. Among full-intensity regimens, a
combination of Fludarabine and standard-dose Busulfan (Flu/BU4) has been investigated
recently and shown to be very well tolerated.
Clofarabine, similar to Fludarabine, is known to have a stronger anti-tumor effect than
Fludarabine and has shown promise in treating aggressive acute leukemias. In addition,
evidence is that it is well-tolerated with manageable side effects especially in older
subjects. Thus replacing Fludarabine with Clofarabine in a full-intensity transplant regimen,
Clo/BU4 may provide a regimen with increased anti-tumor activity without adding significant
risks of toxicity.
The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with
Busulfan as a full-intensity regimen (Clo/BU4) and then (Phase II) to investigate the safety
and effectiveness of this regimen as a conditioning for HSCT in the treatment for aggressive
hematologic malignancies, in subjects where more conventional approaches are failing.
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