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
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
periodically thereafter.
Interventional
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
Day -2
No
Muneer Abidi
Principal Investigator
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
2006-119
NCT01654744
May 2007
March 2014
Name | Location |
---|---|
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |