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Also known as TAK-339, KIOVIG, Immune Globulin Infusion (Human), Intravenous immunoglobulin G
Gammagard Liquid · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Primary Infection Prophylaxis: IGI, 10% | EXPERIMENTAL | Participants randomized to primary infection prophylaxis will receive a 400 milligrams per kilogram (mg/kg) dose of IGI, 10% in accordance with the standard of care (SOC), intravenously (IV) every 3 or 4 weeks within 3 days after randomization up to 12 months. |
| Secondary Infection Prophylaxis: IGI, 10% | ACTIVE_COMPARATOR | Participants randomized to secondary infection prophylaxis will receive a 400 mg/kg dose of IGI, 10% in accordance with the SOC, IV every 3 or 4 weeks only after experiencing at least one serious infection, as determined by the investigator, for the remainder of the 12 months observational period. |
| Name | Type | Description |
|---|---|---|
| IGI, 10% | BIOLOGICAL | IGI, 10% IV infusion. |
Inclusion Criteria: 1. The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the International Myeloma Working Group (IMWG) before enrollment. 2. Participant who recently started teclistamab monotherapy within the first 8 weeks of their planned tr...
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Gammagard Liquid is an immune globulin infusion product, also known as IGI, 10%, being studied to prevent infections in adults with multiple myeloma. It is an investigational therapy in Phase 3 development for patients with multiple myeloma and secondary immunodeficiency. It is developed by Takeda Pharmaceutical Company Limited.
Gammagard Liquid is being studied to prevent infections in adults with multiple myeloma who have secondary immunodeficiency. The Phase 3 trial enrolls adults 18 years and older with multiple myeloma and secondary immunodeficiency. It is not yet approved for this use and remains under clinical investigation.
Gammagard Liquid is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is sponsoring the Phase 3 study evaluating the product for infection prevention in adults with multiple myeloma and secondary immunodeficiency.
Gammagard Liquid is in Phase 3 clinical development. It is investigational and has not been approved for the prevention of infections in adults with multiple myeloma. The ongoing Phase 3 trial is currently recruiting participants across the United States, Australia, Austria, Brazil, Canada, Czechia, Denmark, Greece, Hungary, Israel, Italy, Netherlands, Norway, Poland, Romania, Spain, and the United Kingdom.
Gammagard Liquid is being evaluated in the Phase 3 trial NCT06980480, titled A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma. The trial is recruiting and plans to enroll 183 participants. It is randomized, active-controlled, and open-label, meaning it is not double-blind.
Yes. Gammagard Liquid is also known as IGI, 10%, which is shorthand for Immune Globulin Infusion, 10%. Both names refer to the same Takeda product under Phase 3 study for preventing infections in adults with multiple myeloma and secondary immunodeficiency.