A Phase I/II Dose Escalation Study Assessing the Toxicity and Efficacy of 153-Samarium-EDTMP in Place of TBI in the Conditioning Regimen for PBSCT for Patients With Multiple Myeloma
- To find the maximum tolerated dose of samarium Sm 153 lexidronam pentasodium when given
with fixed high-dose melphalan as a conditioning regimen for autologous peripheral
blood stem cell transplantation in patients with multiple myeloma. (Phase I)
- To assess the response rates of this regimen in these patients. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of samarium Sm 153 lexidronam pentasodium
followed by a phase II study.
- Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV once between days
-14 and -10. Patients also receive melphalan IV on day -1. Patients undergo peripheral
blood stem cell transplantation on day 0. Patients receive sargramostim (GM-CSF)
subcutaneously once daily beginning on day 6 and continuing until blood counts recover.
- Phase II: Patients receive samarium Sm 153 lexidronam pentasodium at the MTD determined
in phase I .
Blood samples are collected periodically to determine clearance of samarium Sm 153
lexidronam pentasodium and bone marrow dosimetry.
Primary Purpose: Treatment
Number of toxicity incidents (Phase I)
Angela Dispenzieri, MD
United States: Federal Government