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

A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 386 (estimated)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypogammaglobulinemia
• Bacterial Infections
• B-cell Chronic Lymphocytic Leukemia
• Multiple Myleoma
• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Xembify	SC infusion pump
DRUG	Placebo	SC infusion pump

Timeline

• Start date: 2022-12-26
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2022-12-09
• Last updated: 2026-04-13

Locations

62 sites across 8 countries: United States, Bosnia and Herzegovina, Bulgaria, Croatia, Hungary, Poland, Romania, Serbia

Regulatory

• FDA-regulated drug study