Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006244
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2000-09-11
Brief Title:
Melphalan Peripheral Stem Cell Transplantation and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Immunotherapy for AutologousSyngeneic Peripheral Blood Stem Cell PBSC Transplant Patients as Treatment for Advanced Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2017-06
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 phase II trial studies the effectiveness of melphalan peripheral stem cell transplantation and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma MM Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Interleukin-2 IL2 may stimulate a persons white blood cells to kill multiple myeloma cells Interferon alfa may interfere with the growth of cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate initial response to therapy time to disease progression and overall survival in MM patients treated with melphalan IL2- incubated peripheral blood stem cells and sequential IL2
SECONDARY OBJECTIVES
I Evaluate grade 3-4 toxicities encountered by younger 56 years old and older 56 years old advanced multiple myeloma patients treated with melphalan IL2-incubated peripheral blood stem cells and sequential IL2
OUTLINE
Patients receive melphalan intravenously IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0 Beginning on day 0 patients also receive IL-2 IV continuously over 5 days followed by 2 days off Treatment with IL-2 repeats weekly for 4 weeks Beginning 1 month later patients undergo maintenance therapy comprising interferon alfa subcutaneously SC 3 times a week in the absence of disease progression or unacceptable toxicity
I Evaluate initial response to therapy time to disease progression and overall survival in MM patients treated with melphalan IL2- incubated peripheral blood stem cells and sequential IL2
SECONDARY OBJECTIVES
I Evaluate grade 3-4 toxicities encountered by younger 56 years old and older 56 years old advanced multiple myeloma patients treated with melphalan IL2-incubated peripheral blood stem cells and sequential IL2
OUTLINE
Patients receive melphalan intravenously IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0 Beginning on day 0 patients also receive IL-2 IV continuously over 5 days followed by 2 days off Treatment with IL-2 repeats weekly for 4 weeks Beginning 1 month later patients undergo maintenance therapy comprising interferon alfa subcutaneously SC 3 times a week in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| NCI-2011-01313 | REGISTRY | CTRP Clinical Trial Reporting Program | None |