drugset / Trial / NCT05645107

A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma

NCT05645107

Phase 3 Recruiting 386 enrolled Grifols Therapeutics LLC
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.

Timeline

Start
2022-12-26
Primary completion
2026-05
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Xembify Protein / enzyme biologic 300 mg/kg Subcutaneous