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Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma — EMBRACE  

Refractory Multiple Myeloma Clinical Trial

Official title:
A Study of Elranatamab Management With Outpatient and Intermittent Dosing in Relapsed/Refractory Multiple Myeloma

Clinical Trial Summary

A phase II study of single agent elranatamab in patients with relapsed and/or 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 and/or refractory multiple myeloma by evaluating an outpatient and intermittent dosing strategy.

Clinical Trial Description

This is a multi-centre, single arm, phase II study of single agent elranatamab in patients with relapsed and/or 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06421675
Study type Interventional
Source Ontario Clinical Oncology Group (OCOG)
Contact Emilio Aguirre, CRA,HIT,CHIM
Phone 905-527-2299
Email aguirre@mcmaster.ca
Status Not yet recruiting
Phase Phase 2
Start date July 2024
Completion date December 2028
View Details
See also
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