Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258206
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2005-11-22
Brief Title:
Rituximab and Cyclophosphamide in Treating Patients With High Risk Refractory or Relapsed Multiple Myeloma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Study of High Dose Cyclophosphamide and Rituximab in Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2017-11
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 such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving rituximab together with cyclophosphamide may kill more cancer cells
PURPOSE This phase II trial is studying how well giving rituximab together with cyclophosphamide works in treating patients with high risk refractory or relapsed multiple myeloma
PURPOSE This phase II trial is studying how well giving rituximab together with cyclophosphamide works in treating patients with high risk refractory or relapsed multiple myeloma
Detailed Description:
OBJECTIVES
Determine the effect of rituximab and high-dose cyclophosphamide on the growth of myeloma stem cells in patients with high-risk refractory or relapsed multiple myeloma
OUTLINE Patients receive rituximab IV on days -10 and -7 once weekly for 4 weeks after completion of high-dose cyclophosphamide and then once in months 3 6 9 and 12 Patients also receive high-dose cyclophosphamide on days -3 to 0
PROJECTED ACCRUAL Not specified
Determine the effect of rituximab and high-dose cyclophosphamide on the growth of myeloma stem cells in patients with high-risk refractory or relapsed multiple myeloma
OUTLINE Patients receive rituximab IV on days -10 and -7 once weekly for 4 weeks after completion of high-dose cyclophosphamide and then once in months 3 6 9 and 12 Patients also receive high-dose cyclophosphamide on days -3 to 0
PROJECTED ACCRUAL Not specified
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 |
|---|---|---|---|
| P30CA006973 | NIH | None | None |
| JHOC-J0478 | OTHER | Johns Hopkins SKCCC | httpsreporternihgovquickSearchP30CA006973 |