A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma

Conditions

• Multiple Myeloma
• Secondary Immunodeficiency

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IGI, 10% — BIOLOGICAL
  IGI, 10% IV infusion.

Study Details

Multiple myeloma is a cancer of the plasma cells in the bone marrow. The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants with multiple myeloma receiving B-cell maturation antigen (BCMA) x cluster of differentiation 3 (CD3) directed bispecific antibody therapy. Participants will be randomly assigned to one of two groups: 1. Primary infection prevention group: They will receive IGI, 10% for 12 months. 2. Secondary infection prevention group: They will only receive IGI, 10% if they develop a serious infection during the 12 months study period. During the study, participants will visit their study clinic 15 times (for 4-week dosing interval) or 19 times (for 3-week dosing interval) and their total participation duration will be up to 14 months (including screening period of up to 8 weeks).

Key Dates

Start date

Jan 14, 2026

Status verified

May 2026

Primary completion

Sep 11, 2028

Completion

Sep 11, 2028

Study Design

Enrollment

183 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Primary Infection Prophylaxis: IGI, 10%
  Participants randomized to primary infection prophylaxis will receive a 400 milligrams per kilogram (mg/kg) dose of IGI, 10%, intravenously (IV) every 3 or 4 weeks within 3 days after randomization up to 12 months.
• Active Comparator: Secondary Infection Prophylaxis: IGI, 10%
  Participants randomized to secondary infection prophylaxis will receive a 400 mg/kg dose of IGI, 10%, 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.

Primary Outcome Measure

Time To the First Serious Infection [ Time Frame: Up to 12 months ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (7)

Find similar trials in Mobile, AL

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