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RECRUITING
NCT07582432
PHASE3

A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma

Sponsor: Grifols Biologicals, LLC

View on ClinicalTrials.gov

Summary

The main goal of this study is to show that people with certain immune problems (from Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma) get fewer serious infections when they receive Gamunex C through an IV once every 4 weeks, along with their usual medical care, for one year. All participants will receive Gamunex-C 500 mg/kg once every 4 weeks (total 13 doses) starting Day 1 (Week 1) through Week 48 (end of Treatment Phase).

Official title: An Open-label, Multi-Center, Single-arm Prospective Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex®-C Plus Standard Medical Treatment to Prevent Infections in Participants With Secondary Antibody Deficiency Associated With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2026-04-23

Completion Date

2028-08-31

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

DRUG

Gamunex-C, 10% Injectable Solution

Sterile solution

Locations (5)

Study Site 102

St. Petersburg, Florida, United States

Study Site 101

Fort Wayne, Indiana, United States

Study Site 105

Westbrook, Maine, United States

Study Site 104

Columbus, Ohio, United States

Study Site 103

Tacoma, Washington, United States