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

NCT06980480 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2026-05-18

No results posted yet for this study

Summary

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).

Conditions

Interventions

BIOLOGICAL

IGI, 10%

IGI, 10% IV infusion.

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Baxalta Innovations GmbH, now part of Takeda

    collaborator UNKNOWN

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-14
Primary Completion
2028-09-11
Completion
2028-09-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Denmark
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06980480 on ClinicalTrials.gov