Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177047
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2005-09-13
Brief Title:
Autologous Transplant for Multiple Myeloma
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Autologous Transplantation for Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 subjects 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 subjects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0312M54569 | OTHER | IRB University of Minnesota | None |
| MT2003-13 | OTHER | None | None |