Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002653
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Cyclophosphamide and Prednisone in Treating Older Patients With Multiple Myeloma
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
VIIITH MYELOMATOSIS TRIAL A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE
Status:
UNKNOWN
Status Verified Date:
2002-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known which combination chemotherapy regimen is most effective in treating older patients with multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without cyclophosphamide and prednisone in treating older patients with multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without cyclophosphamide and prednisone in treating older patients with multiple myeloma
Detailed Description:
OBJECTIVES
Compare the efficacy of doxorubicin carmustine cyclophosphamide and melphalan ABCM with or without oral cyclophosphamide and prednisone as induction for the first plateau phase in elderly patients with previously untreated multiple myeloma
OUTLINE This is a randomized multicenter study Patients are stratified according to center
Patients receive doxorubicin IV followed immediately by carmustine IV over 1-2 hours on day 1 and oral melphalan L-PAM and oral cyclophosphamide CTX on days 22-25 ABCM Treatment continues every 6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients whose blood counts recover within 6 weeks after beginning L-PAM and CTX during course 3 are randomized to 1 of 2 treatment arms Patients whose blood counts fail to recover within 6 weeks after beginning L-PAM and CTX during course 3 are assigned to arm II
Arm I Patients continue ABCM for a maximum of 12 courses in the absence of a plateau phase after completion of at least 4 courses disease progression or unacceptable toxicity
Arm II Patients receive oral cyclophosphamide once weekly and oral prednisone every other day Treatment continues every 6 weeks in the absence of a plateau phase after completion of 3 courses of ABCM plus a minimum of 8 weeks on arm II or less than 3 courses of ABCM plus 6 months on arm II disease progression or unacceptable toxicity
Patients on both arms with bone pain or failure to respond to chemotherapy may undergo minimal radiotherapy Patients achieving plateau phase may enter the MRC trial of interferon alfa-2b
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 1000 patients will be accrued for this study within approximately 5 years
Compare the efficacy of doxorubicin carmustine cyclophosphamide and melphalan ABCM with or without oral cyclophosphamide and prednisone as induction for the first plateau phase in elderly patients with previously untreated multiple myeloma
OUTLINE This is a randomized multicenter study Patients are stratified according to center
Patients receive doxorubicin IV followed immediately by carmustine IV over 1-2 hours on day 1 and oral melphalan L-PAM and oral cyclophosphamide CTX on days 22-25 ABCM Treatment continues every 6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients whose blood counts recover within 6 weeks after beginning L-PAM and CTX during course 3 are randomized to 1 of 2 treatment arms Patients whose blood counts fail to recover within 6 weeks after beginning L-PAM and CTX during course 3 are assigned to arm II
Arm I Patients continue ABCM for a maximum of 12 courses in the absence of a plateau phase after completion of at least 4 courses disease progression or unacceptable toxicity
Arm II Patients receive oral cyclophosphamide once weekly and oral prednisone every other day Treatment continues every 6 weeks in the absence of a plateau phase after completion of 3 courses of ABCM plus a minimum of 8 weeks on arm II or less than 3 courses of ABCM plus 6 months on arm II disease progression or unacceptable toxicity
Patients on both arms with bone pain or failure to respond to chemotherapy may undergo minimal radiotherapy Patients achieving plateau phase may enter the MRC trial of interferon alfa-2b
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 1000 patients will be accrued for this study within approximately 5 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 |
|---|---|---|---|
| EU-94031 | None | None | None |
| MRC-LEUK-MYEL-VIII | None | None | None |