HD Melphalan and SCT in Patients With IGDD or LCDD
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|ClinicalTrials.gov Identifier: NCT00681044|
Recruitment Status : Terminated (Poor accrual)
First Posted : May 20, 2008
Results First Posted : March 15, 2017
Last Update Posted : April 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: filgrastim Drug: melphalan Procedure: Stem Cell Infusion||Phase 2|
- 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High-Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT) in Light-Chain Deposition Disease (LCDD) and Immunoglobulin Deposition Disease (IGDD)|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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, neulasta
70-100 mg/m2/day will be administered intravenously on Days -3 and -2
Other Name: alkeran
Procedure: Stem Cell Infusion
infusion of previously collected stem cells on Day 0
- Hematologic Response Rate [ Time Frame: one year ]
- Predictability of Early Free Light-chain Response for Heme Response [ Time Frame: One month ]
- Organ or Clinical Response [ Time Frame: One year ]
- Overall Survival [ Time Frame: life ]
- Tolerability [ Time Frame: 100 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681044
|United States, Massachusetts|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Vaishali Sanchorawala, MD||Boston Medical Center|