Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the
growth of cancer cells either by killing the cells or by stopping them from dividing.
Samarium Sm 153 lexidronam pentasodium contains a radioactive substance that kill cancer
cells. Peripheral blood stem cell transplant using stem cells from the patient may be able
to replace immune cells that were destroyed by chemotherapy and radioactive drugs used to
kill cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153
lexidronam pentasodium when given together with high-dose melphalan in treating patients
with multiple myeloma undergoing stem cell transplant.
OBJECTIVES:
- 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
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