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 (Sigma).
Sponsor: Grifols Therapeutics LLC
Phase:
Disease: Secondary antibody deficiency, Hypogammaglobulinemia, B-cell chronic lymphocytic leukemia, Multiple myeloma, B-cell non-Hodgkin lymphoma
EU trial number: 2026-526803-31-00
Population: Adults with secondary antibody deficiency and hypogammaglobulinemia (screening IgG <5 g/L) associated with B-cell chronic lymphocytic leukemia, multiple myeloma, or B-cell non-Hodgkin lymphoma. Eligible disease stages are intermediate/high-risk CLL, R-ISS stage II/III multiple myeloma, or advanced B-cell non-Hodgkin lymphoma; participants may have prior severe infections but must not have active infection or recent immunoglobulin replacement therapy.
Register Investigator Interest
Interested in offering this trial to suitable patients?