Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368121
Status:
TERMINATED
Last Update Posted:
2012-07-13
First Post:
2006-08-23
Brief Title:
EMMA-1 Erbitux for Multiple Myeloma
Sponsor:
Prof Dr Andreas Engert
Organization:
University of Cologne
Study Overview
Official Title:
Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1Erbitux for Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of recruitable patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMMA-1
Brief Summary:
EMMA-1 is an open-label non-randomized two-stage phase II study Patients with refractory multiple myeloma stage II or III or relapsed disease after at least one line of treatment will receive Cetuximab-Dexamethasone
The planed treatment duration per patient is 16 weeks Patients achieving a response or stable disease after 16 weeks of treatment may continue study medication for 6 more months patients receiving Cetuximab alone or for 3 more months patients receiving Cetuximab plus Dexamethasone Responding patients who relapse during follow-up period of two years may receive a second treatment with Cetuximab following initial study guidelines
The planed treatment duration per patient is 16 weeks Patients achieving a response or stable disease after 16 weeks of treatment may continue study medication for 6 more months patients receiving Cetuximab alone or for 3 more months patients receiving Cetuximab plus Dexamethasone Responding patients who relapse during follow-up period of two years may receive a second treatment with Cetuximab following initial study guidelines
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