Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421675
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-03-11
Brief Title:
Outpatient and Intermittent Dosing of Elranatamab in RelapsedRefractory Multiple Myeloma
Sponsor:
Ontario Clinical Oncology Group OCOG
Organization:
Ontario Clinical Oncology Group OCOG
Study Overview
Official Title:
A Study of Elranatamab Management with Outpatient and Intermittent Dosing in RelapsedRefractory Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
EMBRACE
Brief Summary:
A phase II study of single agent elranatamab in patients with relapsed andor refractory multiple myeloma MM who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment The primary objective of this study is to improve the tolerability and safety of elranatamab in patients with relapsed andor refractory multiple myeloma by evaluating an outpatient and intermittent dosing strategy
Detailed Description:
This is a multi-centre single arm phase II study of single agent elranatamab in patients with relapsed andor refractory multiple myeloma MM who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment Potential study participants must have documented evidence of refractory or progressive disease during or within 60 days measured from the end of the last cycle of completing treatment with the last anti-myeloma drug regimen used just prior to study entry Study participants will receive SC administration of elranatamab until disease progression unacceptable toxicity or death The primary short term outcome is hospitalization rate within the first 2 weeks of Cycle 1 of treatment the primary long term outcome is rate of grade 3 infections within the first 24 months of treatment Study participants will be followed for survival for 36 months from the date of enrollment A total of 40 study participants will be enrolled across approximately 5 Canadian clinical trial sites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None