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 Subjects With Multiple Myeloma Receiving B-Cell Maturation Antigen×CD3–Directed Bispecific Antibody Therapy

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518420-80-00

Acronym

TAK-339-3001

Enrollment

143

Registered

2025-08-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary infection prophylaxis for secondary immunodeficiency (SID) in patients with multiple myeloma (MM) receiving B cell maturation antigen (BCMA)-directed bispecific (BsAb) therapy

Brief summary

Time to the first serious infection.

Detailed description

1. Occurrence of at least 1 serious infection during the observational period of 12 months., 2. Annualized rate of days on antibiotics (for treatment of bacterial infections)., 3. Annualized rate of bacterial infections.

Interventions

DRUGKIOVIG 100 mg/ml solution for infusion

DRUGTECVAYLI 10 mg/mL solution for injection

DRUGTECVAYLI 90 mg/mL solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to the first serious infection.	—

Secondary

Measure	Time frame
1. Occurrence of at least 1 serious infection during the observational period of 12 months., 2. Annualized rate of days on antibiotics (for treatment of bacterial infections)., 3. Annualized rate of bacterial infections.	—

Countries

Austria, Czechia, Denmark, Germany, Greece, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026