NCT00681044

HD Melphalan and SCT in Patients With IGDD or LCDD

High-Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT) in Light-Chain Deposition Disease (LCDD) and Immunoglobulin Deposition Disease (IGDD)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying the side effects of high-dose melphalan given together with stem cell transplant and to see how well it works in treating patients with immunoglobulin deposition disease or light-chain deposition disease.

Detailed description

OBJECTIVES: * To assess the tolerability of high-dose melphalan and autologous stem cell transplantation in patients with immunoglobulin deposition disease or light-chain deposition disease. * To determine the hematologic response rate in patients treated with this regimen. * To determine the predictability of early free light-chain response for heme response in patients treated with this regimen. * To determine organ or clinical response in patients treated with this regimen. * To determine overall survival of these patients. OUTLINE: * Stem cell mobilization: Patients undergo blood stem cell mobilization comprising filgrastim (G-CSF) subcutaneously once daily for 3 days (i.e., through the day before the last stem cell collection). * Stem cell collection: Patients undergo collection of G-CSF-mobilized blood stem cells until the target number of stem cells (at least 2 x 10\^6 cluster of differentiation-34-positive cells) is reached. * Conditioning regimen: Patients receive high-dose melphalan IV on days -3 to -2. * Autologous stem cell transplantation: Patients undergo blood stem cell infusion on day 0. After completion of study therapy, patients are followed at 3, 6, and 12 months and then annually thereafter.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
DRUG	melphalan	70-100 mg/m2/day will be administered intravenously on Days -3 and -2
PROCEDURE	Stem Cell Infusion	infusion of previously collected stem cells on Day 0

Timeline

• Start date: 2006-10-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2008-05-20
• Last updated: 2017-04-28
• Results posted: 2017-03-15

Locations

1 site across 1 country: United States