Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003554
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
1999-11-01
Brief Title:
Rituximab in Treating Patients With Multiple Myeloma
Sponsor:
The Cleveland Clinic
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Rituxan in the Management of Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2008-03
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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them
PURPOSE Phase II trial to study the effectiveness of the monoclonal antibody rituximab in treating patients with multiple myeloma that is newly diagnosed
PURPOSE Phase II trial to study the effectiveness of the monoclonal antibody rituximab in treating patients with multiple myeloma that is newly diagnosed
Detailed Description:
OBJECTIVES I Evaluate the role of rituximab in inducing apoptosis of malignant plasma cells in patients with multiple myeloma II Evaluate the role of this regimen in improving the response rate to melphalan and prednisone in these patients III Determine whether the regimen decreases residual disease in these patients IV Evaluate the toxic effects of this regimen in these patients
OUTLINE Patients receive rituximab IV every week for 4 weeks Treatment is repeated every 6 months for six courses Treatment may be discontinued after four courses if uncontrolled infection occurs Patients also receive oral melphalan and prednisone for 4 days which begin after the first course of rituximab Treatment is repeated every 4-6 weeks for at least nine courses
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study within 12-24 months
OUTLINE Patients receive rituximab IV every week for 4 weeks Treatment is repeated every 6 months for six courses Treatment may be discontinued after four courses if uncontrolled infection occurs Patients also receive oral melphalan and prednisone for 4 days which begin after the first course of rituximab Treatment is repeated every 4-6 weeks for at least nine courses
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study within 12-24 months
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-V98-1462 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066613 | REGISTRY | None | None |