Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IGI, 10%
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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