NCT00177047

Autologous Transplant for Multiple Myeloma

Autologous Transplantation for Multiple Myeloma

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.

Detailed description

Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check the subject's general health. Subjects will have the following tests and evaluations to find out if they can participate:--Medical history and physical examination, including height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum pregnancy test performed. After eligible patients have been completely staged and exercised consent, they may undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection. All patients will receive high-dose melphalan followed by an autologous stem cell transplant (SCT). Blood tests will be performed frequently to evaluate the subject's response to treatment and possible side effects of treatment. If necessary, platelet and red cell transfusions will be given to maintain adequate levels and antibiotics will be given to treat or prevent infection. Subjects may also require intravenous nutritional support and pain medications during or after transplantation. The study coordinators will collect health information over three years. They will collect information every week for 100 days, then at 6 months, 1 year, 2 years, and 3 years.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	Stem Cell Transplant	As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
DRUG	Cyclophosphamide + Mesna	Cyclophosphamide: 4mg/m\^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.
DRUG	Melphalan	Administered intravenously 200 mg/m\^2
BIOLOGICAL	Granulocyte-colony stimulating factor	Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.

Timeline

• Start date: 2004-04-20
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2005-09-15
• Last updated: 2021-11-09
• Results posted: 2021-11-09

Locations

1 site across 1 country: United States