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 BCMA×CD3–Directed Bispecific Antibody Therapy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Takeda Development Center Americas Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2025-08-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Takeda Development Center Americas, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Safety, Pharmacodynamic, Efficacy, Pharmacokinetic

To assess the efficacy of IGI, 10% treatment for primary infection prophylaxis compared with secondary infection prophylaxis.

Secondary objectives 3

1. 1. To assess the impact of IGI, 10% treatment on all infections and infection-related outcomes.
2. 2. To assess safety and tolerability of IGI, 10% for infection prophylaxis.
3. 3. To assess the impact of IGI, 10% treatment on frequency and duration of hospitalization due to infection.

Conditions and MedDRA coding

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

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment#8. These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. The subject must have a documented diagnosis of MM according to the guidelines by the IMWG before enrollment.
2. 2. Subjects 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.
3. 3. The subject has provided informed consent (ie, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any study procedures.
4. 4. The subject is at least 18 years of age at the time of signing the ICF.
5. 5. 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.

Exclusion criteria 29

1. 1. The subject has not achieved at least a minimal response to teclistamab within 8 weeks during the screening period.
2. 2. The subject has a current serious infection or >1 serious infection in the past 3 months before screening.
3. 3. The subject has a documented polyclonal IgG level <150 mg/dL at the most recent assessment before teclistamab initiation (within 4 weeks) as assessed by the investigator according to the site’s standard practice.
4. 4. The subject is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.
5. 5. The subject has received a hyperimmune or specialty high-titer immunoglobulin product (eg, cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin) within 30 days before screening.
6. 6. The subject has received live viral vaccines within 30 days before screening.
7. 7. The subject has an Eastern Cooperative Oncology Group performance status score of >2.
8. 8. The subject has an active viral or bacterial infection or symptoms/signs of such an infection requiring treatment with anti-infectives within 1 week before enrollment.
9. 9. The subject has received other BCMA×CD3–directed BsAb therapy any time before screening.
10. 10. The subject is scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening.
11. 11. The subject may be excluded from the study if, in the opinion of the investigator, the subject is at high risk for symptomatic hyperviscosity syndrome.
12. 12. The subject has major surgery scheduled during the study, or the subject has not fully recovered from a recent major surgery (as judged by the investigator) during screening (subjects with planned surgical procedures to be conducted under local anesthesia may participate).
13. 13. The subject has an active secondary (non-MM) malignancy or other medical condition with life‑expectancy of <2 years.
14. 14. The subject has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) after IVIG and/or immune serum globulin infusions.
15. 15. The subject has a known history or current diagnosis of thromboembolic episodes such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease within 6 months before screening.
16. 16. The subject has moderate to severe renal dysfunction based on an estimated glomerular filtration rate ≤30 mL/min/1.73 m2, as defined by Kidney Disease: Improving Global Outcomes Clinical Practice Guideline for the Management of Glomerular Diseases, 2021 at the time of screening.
17. 17. The subject has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen, PCR for hepatitis C virus, PCR for HIV Type 1 and Type 2. Cured subjects with a history of hepatitis C infection who have a negative PCR test at screening are eligible.
18. 18. The subject has a documented diagnosis of a form of PID involving a defect in antibody formation and requiring IgG replacement, as defined according to the International Union of Immunological Societies Committee.
19. 19. The subject has a persistent serum aspartate aminotransferase and alanine aminotransferase >3.0 times the upper limit of normal at screening (may be repeated once to determine if it is persistent).
20. 20. The subject has an immunoglobulin A (IgA) deficiency (<0.07 g/L) with antibodies to IgA and a history of hypersensitivity reaction to IVIG.
21. 21. Subjects with a known systemic hypersensitivity to any of the excipients of IGI, 10% in accordance with the investigator’s brochure/package insert/Summary of Product Characteristics.
22. 22. Known substance abuse including opiates, psychostimulant agents, or other illicit drugs with the exception of cannabinoids within 12 months of screening.
23. 23. The subject has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator (may be repeated once to determine if it has resolved).
24. 24. The subject has a medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with the successful completion of the study or place the subject at undue medical risk.
25. 25. The subject is receiving immunosuppressive treatment (other than for MM or corticosteroids) at screening or plans to receive immunosuppressive treatment after study enrollment.
26. 26. The subject is not willing and able to comply with the protocol requirements.
27. 27. The subject has participated or is scheduled to participate in another clinical study involving an IP or investigational device within 30 days before screening and during the course of the study.
28. 28. The subject is a family member or employee of the investigator or the investigator’s site staff.
29. 29. The subject is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to the first serious infection.

Secondary endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Takeda Development Center Americas Inc.

Sponsor organisation

Takeda Development Center Americas Inc.

Address

500 Kendall Street

City

Cambridge

Postcode

02142-1108

Country

United States

Scientific contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Filiz Seeborg

Public contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Takeda

Third parties 9

Locations

12 EU/EEA countries · 44 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 192 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications