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Clinical Trial Summary

This is a single-arm, prospective, non-interventional, real-world study to observe and evaluate the efficacy and safety of selinexor in combination with daratumumab and dexamethasone in patients with multiple myeloma at first relapse.


Clinical Trial Description

This is a non-interventional, prospective, observational post-marketing surveillance study of selinexor, daratumumab and dexamethasone in participants with multiple myeloma (MM). The study will assess the safety and effectiveness of selinexor in combination with daratumumab and dexamethasone (XDd) for first relapse MM patients under real-world conditions. The study will enroll approximately 34 participants. The data will be prospectively collected, at our center from medical files and recorded into electronic case report forms (e-CRFs). The overall duration of the study will be approximately 3 years. Data will be collected over and up to a 12 months-surveillance period (per participant) once enrolled. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05559788
Study type Observational
Source The First Affiliated Hospital of Soochow University
Contact
Status Not yet recruiting
Phase
Start date September 20, 2022
Completion date June 1, 2025