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

StatusRecruiting
PhasePhase 3
SponsorTakeda
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 56 → 65 locations
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 1 of 23 entries
  2. Trial sites expanded: 48 → 56 locationsv12
  3. Trial sites expanded: 42 → 48 locationsv11
  4. Trial sites expanded: 28 → 42 locations
    • Eligibility criteria expanded, about 16 words
    v10
  5. Trial sites expanded: 24 → 28 locationsv9
  6. Trial sites expanded: 16 → 24 locationsv8
  7. Study sites: 12 to 16v7
  8. Study sites: 16 to 12v6
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 17 to 16
    • Start date changed from estimate of Jan 28, 2026 to Jan 14, 2026
    v5
  10. Start date: Nov 29, 2025 to Jan 28, 2026v4
  11. Start date: Sep 8, 2025 to Nov 29, 2025
    • Study sites: 18 to 17
    v3
  12. Start date: Aug 1, 2025 to Sep 8, 2025
    • Study sites: 0 to 18
    v2
  13. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Takeda
222 trials monitored
See 14 trials at risk
Multiple Myeloma
1,264 trials monitored
See 78 trials at risk
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 approximately 8 weeks).
Trial Details
NCT Number NCT06980480
Lead Sponsor Takeda
Collaborators: Takeda Development Center Americas, Inc., Baxalta Innovations GmbH, now part of Takeda
Conditions
(from sponsor)		 Multiple Myeloma, Secondary Immunodeficiency
Related terms Multiple Myeloma
Enrollment 183 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov