Phase I Dose Escalation Trial of High Dose Melphalan Conditioning Regimen With Palifermin for Cytoprotection Followed by Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
I. To determine the maximum-tolerated dose (MTD) of melphalan in patients with normal and
abnormal renal function undergoing autologous stem cell transplants for myeloma when treated
with palifermin to prevent mucositis.
I. To assess overall response (compete response [CR], partial response [PR], stable disease
[SD]) at D+28 and D+100 after autologous transplant when treated with combination of
palifermin and Melphalan.
II. To evaluate the efficacy of Palifermin as a cytoprotective agent in reducing incidence
and duration of Grade 3 and 4 mucositis due to high dose Melphalan.
III. To assess patient reported outcomes and impact of using palifermin on quality of life
in the post transplant duration.
IV. To assess the qualitative and quantitative toxicities associated with this regimen.
OUTLINE: This is a dose-escalation study of melphalan.
CONDITIONING REGIMEN: Patients receive high-dose melphalan intravenously (IV) on day -2 and
palifermin IV on days -5 to -3 and 1-3.
TRANSPLANTATION: Patients undergo autologous PBSCT on day 0.
After completion of study treatment, patients are followed up at days 28 and 100, and then
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Independent determination of the MTD of high-dose melphalan in Strata I and II
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|