Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002678
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Multiple Myeloma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
Comparative Study of Dexamethasone vs Prednisone Both in Combination With Melphalan as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone vs no Additional Treatment as Maintenance Therapy in Non-Progressing Patients
Status:
COMPLETED
Status Verified Date:
2020-03
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 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 patients with multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients with multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients with multiple myeloma
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with previously untreated stage I-III multiple myelome treated with melphalan combined with dexamethasone or prednisone as induction therapy
Compare the overall survival of patients with stable or responding disease after induction treated with dexamethasone vs observation alone as maintenance therapy
Compare the time to progression response rate and quality of life of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by center stage I or II vs III creatinine less than 20 mgdL vs 20 mgdL or greater and intention to use prophylactic bisphosphonate yes vs no
Induction Patients are randomized to 1 of 4 treatment arms
Arms I and II Patients receive induction comprising oral prednisone followed by oral melphalan on days 1-4
Arms III and IV Patients receive induction comprising oral melphalan and oral dexamethasone DM on days 1-4 of all courses and DM on days 15-18 of courses 1-3
Induction for arms I-IV continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after induction proceed to maintenance therapy
Maintenance
Arms I and III Patients undergo observation
Arms II and IV Patients receive oral DM on days 1-4 Maintenance therapy continues every 4 weeks for arms II and IV and every 3 months for arms I and III in the absence of disease progression or unacceptable toxicity Patients on arms I-IV who develop disease progression proceed to reinduction
Reinduction Patients restart induction on the arm to which they were originally randomized Reinduction continues every 4 weeks in the absence of stable response lasting 16 weeks disease progression or unacceptable toxicity Patients who achieve a stable response lasting 16 weeks restart maintenance therapy Patients who experience further disease progression during reinduction are taken off study
Quality of life is assessed at baseline on day 1 of courses 1-3 and then every 3 courses during induction and then every 3 months during maintenance therapy
Patients are followed every 6 months
PROJECTED ACCRUAL A maximum of 600 patients will be accrued for this study within 6 years
Compare the overall survival of patients with previously untreated stage I-III multiple myelome treated with melphalan combined with dexamethasone or prednisone as induction therapy
Compare the overall survival of patients with stable or responding disease after induction treated with dexamethasone vs observation alone as maintenance therapy
Compare the time to progression response rate and quality of life of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by center stage I or II vs III creatinine less than 20 mgdL vs 20 mgdL or greater and intention to use prophylactic bisphosphonate yes vs no
Induction Patients are randomized to 1 of 4 treatment arms
Arms I and II Patients receive induction comprising oral prednisone followed by oral melphalan on days 1-4
Arms III and IV Patients receive induction comprising oral melphalan and oral dexamethasone DM on days 1-4 of all courses and DM on days 15-18 of courses 1-3
Induction for arms I-IV continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after induction proceed to maintenance therapy
Maintenance
Arms I and III Patients undergo observation
Arms II and IV Patients receive oral DM on days 1-4 Maintenance therapy continues every 4 weeks for arms II and IV and every 3 months for arms I and III in the absence of disease progression or unacceptable toxicity Patients on arms I-IV who develop disease progression proceed to reinduction
Reinduction Patients restart induction on the arm to which they were originally randomized Reinduction continues every 4 weeks in the absence of stable response lasting 16 weeks disease progression or unacceptable toxicity Patients who achieve a stable response lasting 16 weeks restart maintenance therapy Patients who experience further disease progression during reinduction are taken off study
Quality of life is assessed at baseline on day 1 of courses 1-3 and then every 3 courses during induction and then every 3 months during maintenance therapy
Patients are followed every 6 months
PROJECTED ACCRUAL A maximum of 600 patients will be accrued for this study within 6 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000064328 | OTHER | PDQ | None |
| CAN-NCIC-MY7 | OTHER | None | None |
| NCI-V95-0713 | OTHER | None | None |