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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
EU CTIS ID: 2024-518420-80-00
What this study is testing
To assess the efficacy of IGI, 10% treatment for primary infection prophylaxis compared with secondary infection prophylaxis.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. The subject must have a documented diagnosis of MM according to the guidelines by the IMWG before enrollment.
- 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. 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. The subject is at least 18 years of age at the time of signing the ICF.
- 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.
You likely can't join if
- 1. The subject has not achieved at least a minimal response to teclistamab within 8 weeks during the screening period.
- 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. 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. 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. The subject has an active secondary (non-MM) malignancy or other medical condition with life‑expectancy of <2 years.
- 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.
See the full eligibility criteria
Who can join
- 1. The subject must have a documented diagnosis of MM according to the guidelines by the IMWG before enrollment.
- 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. 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. The subject is at least 18 years of age at the time of signing the ICF.
- 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.
What rules you out
- 1. The subject has not achieved at least a minimal response to teclistamab within 8 weeks during the screening period.
- 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. 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. 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. The subject has an active secondary (non-MM) malignancy or other medical condition with life‑expectancy of <2 years.
- 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. 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. 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. 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. 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. 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).
- 2. The subject has a current serious infection or >1 serious infection in the past 3 months before screening.
- 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. 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. Known substance abuse including opiates, psychostimulant agents, or other illicit drugs with the exception of cannabinoids within 12 months of screening.
- 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. 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. The subject is receiving immunosuppressive treatment (other than for MM or corticosteroids) at screening or plans to receive immunosuppressive treatment after study enrollment.
- 26. The subject is not willing and able to comply with the protocol requirements.
- 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. The subject is a family member or employee of the investigator or the investigator’s site staff.
- 29. The subject is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.
- 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. The subject is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.
- 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. The subject has received live viral vaccines within 30 days before screening.
- 7. The subject has an Eastern Cooperative Oncology Group performance status score of >2.
- 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. The subject has received other BCMA×CD3–directed BsAb therapy any time before screening.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Australia
- United States
- United Kingdom
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Australia; United States; United Kingdom; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.