HD Melphalan and SCT in Patients With IGDD or LCDD
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.
Procedure: Stem Cell Infusion
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||High-Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT) in Light-Chain Deposition Disease (LCDD) and Immunoglobulin Deposition Disease (IGDD)|
- Hematologic response rate [ Time Frame: one year ] [ Designated as safety issue: No ]
- Predictability of early free light-chain response for heme response [ Time Frame: One month ] [ Designated as safety issue: No ]
- Organ or clinical response [ Time Frame: One year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: life ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||February 2030|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: SCT with melphalan conditioning
Mobilization with Filgrastim Stem Cell Transplant Melphalan Conditioning Stem Cell infusion
16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
Other Name: G-CSF, neulastaDrug: melphalan
70-100 mg/m2/day will be administered intravenously on Days -3 and -2
Other Name: alkeranProcedure: Stem Cell Infusion
infusion of previously collected stem cells on Day 0
- 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.
- 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 CD34+ 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681044
|United States, Massachusetts|
|Boston University Cancer Research Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Clinical Trials Office - Boston University Cancer Research Cen 617-638-8265|
|Principal Investigator:||Vaishali Sanchorawala, MD||Boston Medical Center|