Clinical Trial

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

Study acronym: SIGMA
Recruiting Phase 3
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).
Trial Details
NCT Number NCT07582432
Lead Sponsor Grifols Biologicals, LLC
Conditions Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
Enrollment 49 participants
Start Date 2026-04-23
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-12