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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

DRUG

Xembify

SC infusion pump

DRUG

Placebo

SC infusion pump

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-26
Primary Completion
2026-05-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Bosnia and Herzegovina
  • Bulgaria
  • Croatia
  • Hungary
  • Poland
  • Romania
  • Serbia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05645107 on ClinicalTrials.gov