Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002556
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without High Dose Cyclophosphamide and Recombinant Interferon Alfa-2b in Treating Patients With Previously Untreated Stage I-III Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
The Treatment of Multiple Myeloma Utilizing VBMCP Chemotherapy Alternating With High-Dose Cyclophosphamide and Alpha2b-Interferon Versus VBMCP A Phase III Study for Previously Untreated Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-05
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 randomized phase III clinical trial studies combination chemotherapy with high dose cyclophosphamide and recombinant interferon alfa-2b to see how well it works compared to combination chemotherapy alone in treating patients with previously untreated stage I-III multiple myeloma Drugs used in chemotherapy such as vincristine sulfate carmustine melphalan cyclophosphamide and prednisone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Recombinant interferon alfa-2b may interfere with the growth of cancer cells It is not yet know whether giving combination chemotherapy with or without alternating high-dose cyclophosphamide and recombinant interferon alfa-2b is more effective in treating multiple myeloma
Detailed Description:
PRIMARY OBJECTIVES
I To compare response rate time to response duration of response toxicity and survival in the two regimens vincristine sulfate carmustine melphalan cyclophosphamide prednisone VBMCP vs VBMCP alternating with high-dose cyclophosphamide and then with recombinant interferon alfa-2b r alpha2b-IFN in patients with previously untreated multiple myeloma
II To determine the value of the ancillary laboratory studies to predict response and survival
OUTLINE
INDUCTION PHASE Patients receive VBMCP comprising vincristine sulfate intravenously IV on day 1 carmustine IV on day 1 melphalan orally PO on days 1-4 cyclophosphamide IV on day 1 and prednisone PO on days 1-7 Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity
CONSOLIDATION PHASE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive VBMCP as in the induction phase Courses repeat every 35 days in the absence of disease progression or unacceptable toxicity
ARM B Patients receive vincristine sulfate carmustine and melphalan as in the induction phase high-dose cyclophosphamide IV on days 1-4 and prednisone PO on days 1-4 during courses 3 and 5 Patients receive VBMCP as in the induction phase during even numbered courses Patients receive recombinant interferon alfa-2b subcutaneously SC on days 1 3 5 8 10 12 15 17 19 and 22 during odd courses beginning course 7 Treatment repeats every 35 days for courses 3-5 every 21 days for even courses beginning course 6 and every 22 days for odd courses beginning course 7 in the absence of disease progression or unacceptable toxicity
In both arms treatment continues for up to 2 years
After completion of study treatment patients are followed up for 1 year
I To compare response rate time to response duration of response toxicity and survival in the two regimens vincristine sulfate carmustine melphalan cyclophosphamide prednisone VBMCP vs VBMCP alternating with high-dose cyclophosphamide and then with recombinant interferon alfa-2b r alpha2b-IFN in patients with previously untreated multiple myeloma
II To determine the value of the ancillary laboratory studies to predict response and survival
OUTLINE
INDUCTION PHASE Patients receive VBMCP comprising vincristine sulfate intravenously IV on day 1 carmustine IV on day 1 melphalan orally PO on days 1-4 cyclophosphamide IV on day 1 and prednisone PO on days 1-7 Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity
CONSOLIDATION PHASE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive VBMCP as in the induction phase Courses repeat every 35 days in the absence of disease progression or unacceptable toxicity
ARM B Patients receive vincristine sulfate carmustine and melphalan as in the induction phase high-dose cyclophosphamide IV on days 1-4 and prednisone PO on days 1-4 during courses 3 and 5 Patients receive VBMCP as in the induction phase during even numbered courses Patients receive recombinant interferon alfa-2b subcutaneously SC on days 1 3 5 8 10 12 15 17 19 and 22 during odd courses beginning course 7 Treatment repeats every 35 days for courses 3-5 every 21 days for even courses beginning course 6 and every 22 days for odd courses beginning course 7 in the absence of disease progression or unacceptable toxicity
In both arms treatment continues for up to 2 years
After completion of study treatment patients are followed up for 1 year
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 |
|---|---|---|---|
| U10CA021115 | NIH | None | httpsreporternihgovquickSearchU10CA021115 |
| E5A93 | None | None | None |
| ECOG-E5A93 | None | None | None |