Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003195
Status:
COMPLETED
Last Update Posted:
2011-11-17
First Post:
1999-11-01
Brief Title:
Total-Body Irradiation Busulfan and Interferon Alfa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Multiple Myeloma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Study of Total Marrow Irradiation Busulfan and Alpha-Interferon Followed by Allogeneic Peripheral Blood Stem Cell or Marrow Transplantation for Treatment of Patients With Advanced Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2011-11
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:
RATIONALE Radiation therapy uses high-energy x-rays to damage cancer cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Interferon alfa may interfere with the growth of cancer cells
PURPOSE Phase II trial to study the effectiveness of total-body irradiation busulfan and interferon alfa followed by peripheral stem cell or bone marrow transplantation in treating patients with multiple myeloma
PURPOSE Phase II trial to study the effectiveness of total-body irradiation busulfan and interferon alfa followed by peripheral stem cell or bone marrow transplantation in treating patients with multiple myeloma
Detailed Description:
OBJECTIVES I Evaluate the effects of total marrow irradiation and busulfan followed by allogeneic peripheral blood stem cell or marrow transplantation on the outcomes of treatment related mortality response relapse survival and event free survival for patients with advanced multiple myeloma
OUTLINE Peripheral blood stem cell PBSC or bone marrow BM collection and infusion are performed according to standard practice Patients undergo total marrow irradiation TMI bid for 3 days Busulfan is administered every 6 hours on days -6 to -3 PBSC or BM is infused on day 0 Interferon alfa is administered subcutaneously on Mondays Wednesdays and Fridays beginning on day 80 Interferon therapy may continue in the absence of graft versus host disease or disease progression Patients are followed on days 56 and 84 then every 6 months for 2 years and annually thereafter
PROJECTED ACCRUAL A maximum of 30 patients will be accrued over 3 years
OUTLINE Peripheral blood stem cell PBSC or bone marrow BM collection and infusion are performed according to standard practice Patients undergo total marrow irradiation TMI bid for 3 days Busulfan is administered every 6 hours on days -6 to -3 PBSC or BM is infused on day 0 Interferon alfa is administered subcutaneously on Mondays Wednesdays and Fridays beginning on day 80 Interferon therapy may continue in the absence of graft versus host disease or disease progression Patients are followed on days 56 and 84 then every 6 months for 2 years and annually thereafter
PROJECTED ACCRUAL A maximum of 30 patients will be accrued over 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 |
|---|---|---|---|
| FHCRC-127200 | None | None | None |
| NCI-H98-0009 | None | None | None |
| CDR0000066030 | REGISTRY | PDQ | None |