Ignite Creation Date:
2024-05-06 @ 7:05 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02467010
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2014-02-17
Brief Title:
Relapse Myeloma Cyclofosfamide Bortezomib Maintenance
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Bortezomib in Combination With Continuous Low-dose Oral Cyclophosphamide and Dexamethason Followed by Maintenance in Primary Refractory or Relapsed Bortezomib naïve Multiple Myeloma Patients A Prospective Phase II Study
Status:
COMPLETED
Status Verified Date:
2015-06
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:
REMM
Brief Summary:
Bortezomib and cyclophosphamide in combination with dexamethasone has already demonstrated high response rates in refractory multiple myeloma Low dose continuous cyclophosphamide also called metronomic scheduling minimize toxic side effects and eliminate the obligatory rest periods Combining cyclophosphamide with bortezomib might target distinct aspects of a myeloma functionality
The objectives of the present study are whether patients with refractory or relapsed multiple myeloma after reinduction with bortezomib cyclophosphamide and dexamethasone will benefit from maintenance therapy with bortezomib and cyclophosphamide with acceptable side-effects Recently two studies have shown with thalidomide that maintenance therapy might improve EFS and one study also the OS
The objectives of the present study are whether patients with refractory or relapsed multiple myeloma after reinduction with bortezomib cyclophosphamide and dexamethasone will benefit from maintenance therapy with bortezomib and cyclophosphamide with acceptable side-effects Recently two studies have shown with thalidomide that maintenance therapy might improve EFS and one study also the OS
Detailed Description:
None
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 |
|---|---|---|---|
| 2008-004822-17 | EUDRACT_NUMBER | None | None |