Samarium Sm 153 Lexidronam Pentasodium and High-Dose Melphalan in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant
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.
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: sargramostim Drug: melphalan Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: samarium Sm 153 lexidronam pentasodium||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|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|
- Number of toxicity incidents (Phase I)
- Proportion of successes (Phase II)
- Number of responses (Phase I)
- Overall survival (Phase II)
- Progression-free survival (Phase II)
- Time to progression (Phase II)
- Progressive disease variables
|Study Start Date:||January 2000|
|Study Completion Date:||July 2010|
|Primary Completion Date:||June 2003 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602706
|Study Chair:||Angela Dispenzieri, MD||Mayo Clinic|