Condition

Multiple Myeloma

Purpose of the study

To assess the efficacy of IGI, 10% treatment for primary infection prophylaxis compared with secondary infection prophylaxis. NCT06980480

Official Title

A Multicenter, Randomized, Controlled, Open-Label, Group-Sequential, Phase 3 Study to Investigate the Efficacy, Safety, and Tolerability of Intravenous Gammagard Liquid (Immune Globulin Infusion, 10%) for Primary Infection Prophylaxis Compared With Secondary Infection Prophylaxis in Adult Patients With Multiple Myeloma Receiving B-cell Maturation-Antigen–Directed Bispecific Antibody Therapy.

Who is eligible to participate?

Inclusion criteria

Subjects must meet ALL of the following criteria to be eligible for inclusion in the study:

• The subject must have a documented diagnosis of MM according to the guidelines by the IMWG before enrollment.
• Subjects who recently started teclistamab within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months.

Exclusion criteria

The subject will be excluded from the study if ANY of the following exclusion criteria are met:

• The subject has not achieved at least a minimal response to teclistamab within 8 weeks during the screening period.
• The subject has a current serious infection or >1 serious infection in the past 3 months before screening.
• The subject has a documented polyclonal IgG level <150 mg/dL at the most recent assessment before teclistamab initiation (within 4 weeks) as assessed by the investigator according to the site’s standard practice.
• The subject is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.
• The subject has received a hyperimmune or specialty high-titer immunoglobulin product (eg,cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin) within 30 days before screening.
• The subject has received other BCMA×CD3–directed BsAb therapy any time before screening.
   

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane