Secondary Immunodeficiency (SID) Clinical Trials

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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 AntigenxCD3-Directed Bispecific Antibody Therapy

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the International Myeloma Working Group (IMWG) before enrollment.

• Participant who recently started teclistamab within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months.

• The participant or the participant's legally acceptable representative has provided informed consent (that is, in writing, documented via a signed and dated Informed Consent Form \[ICF\]) and any required privacy authorization before the initiation of any study procedures.

• The participant is at least 18 years of age at the time of signing the ICF.

• If a person of childbearing potential engages in sexual relations that carry risk of pregnancy, they agree to the following for the period from screening until 30 days after the last dose of study drug:

‣ To use a highly effective contraceptive method.

⁃ To avoid donating ova.

Locations
United States
Alabama
Infirmary Health - Diagnostic & Medical Clinic (DMC)
RECRUITING
Mobile
California
Chao Family Comprehensive Cancer Center UCI
RECRUITING
Orange
Kansas
University of Kansas
RECRUITING
Westwood
Maryland
University of Maryland | Greenebaum Cancer Center
RECRUITING
Baltimore
Michigan
Henry Ford Health System
RECRUITING
Detroit
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
East Carolina University
NOT_YET_RECRUITING
Greenville
New York
New York Oncology Hematology
RECRUITING
Albany
Ohio
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
Other Locations
United Kingdom
Cardiff & Vale University Health Board
RECRUITING
Cardiff
Colchester General Hospital
NOT_YET_RECRUITING
Colchester
Royal Devon And Exeter Hospital
NOT_YET_RECRUITING
Exeter
Gloucestershire Royal Hospital
RECRUITING
Gloucester
Harrogate and District NHS Foundation Trust
NOT_YET_RECRUITING
Harrogate
Milton Keynes University Hospital NHS Foundation Trust
NOT_YET_RECRUITING
Milton Keynes
County Hospital (Stafford Hospital)
RECRUITING
Stafford
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2026-01-14
Estimated Completion Date: 2028-09-11
Participants
Target number of participants: 183
Treatments
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.
Sponsors
Collaborators: Takeda Development Center Americas, Inc., Baxalta Innovations GmbH, now part of Takeda
Leads: Takeda

This content was sourced from clinicaltrials.gov