Approval Probability
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ML Risk
IGI, 10% · 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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IGI, 10% is an investigational monoclonal antibody being studied for the prevention of infections in adults with multiple myeloma. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
IGI, 10% is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being investigated for its potential to prevent infections in patients with multiple myeloma.
IGI, 10% is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company is conducting a Phase 3 clinical trial to evaluate the drug in multiple myeloma patients.
IGI, 10% is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The ongoing trial is actively recruiting participants.
IGI, 10% is being studied in a Phase 3 trial with the identifier NCT06980480. This randomized, active-controlled study is evaluating the drug for preventing infections in adults with multiple myeloma and secondary immunodeficiency, with an enrollment target of 183 participants.
IGI, 10% is also known as Gammagard Liquid (Immune Globulin Infusion, 10%). The clinical trial NCT06980480 refers to the drug by this alternative name, indicating that IGI, 10% and Gammagard Liquid are the same product.