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Looking for participantsPhase3

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

Sponsor: Takeda

NCT ID: NCT06980480

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
IGI, 10% (biological)
How long the study runs
Study runs about 32 months (dates as stated)
About the drug or intervention
IGI, 10% — biological: IGI, 10% IV infusion.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
183
Started
2026-01-14
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple myeloma
  • • Phase3 - 183 participants
  • • Multiple myeloma is a cancer of the plasma cells in the bone marrow

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with multiple myeloma

Where?

  • • Exeter - Royal Devon And Exeter Hospital
  • • Colcester - Colchester General Hospital
  • • Gloucester - Gloucestershire Royal Hospital
  • • Cardiff - Cardiff & Vale University Health Board
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Multiple MyelomaSecondary Immunodeficiency

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD3or is positivehave a negativehas a positive

Treatment history

Treatments you must have had:

  • ✓ privacy authorization

What the study is looking for

  • ✓The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the...
  • ✓Participant who recently started teclistamab monotherapy within the first 8 weeks of their planned treatment...
  • ✓The participant is at least 18 years of age at the time of signing the ICF.
  • ✓To use a highly effective contraceptive method.
  • ✓To avoid donating ova.

Who cannot take part

  • ✗The participant has not achieved at least a minimal response to teclistamab during the screening period after...
  • ✗The participant has a current serious infection or greater than (\>) 1 serious infection in the past 3 months before...
  • ✗The participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16...
  • ✗The participant has received live viral vaccines within 30 days before screening.
  • ✗The participant has an activity scale performance status score of \>2.
See the full criteria
Inclusion Criteria: 1. The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the International Myeloma Working Group (IMWG) before enrollment. 2. Participant who recently started teclistamab monotherapy within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months. 3. The participant 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. 4. The participant 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: 1. To use a highly effective contraceptive method. 2. To avoid donating ova. Exclusion Criteria: 1. The participant has not achieved at least a minimal response to teclistamab during the screening period after signing the ICF and within 8 weeks of the first step-up dose of teclistamab. 2. The participant has a current serious infection or greater than (\>) 1 serious infection in the past 3 months before screening. 3. The participant has a documented polyclonal IgG level less than (\<) 150 milligrams per deciliter (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 participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening. 5. The participant has received a hyperimmune or specialty high-titer immunoglobulin product (example, cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin) within 30 days before screening. 6. The participant has received live viral vaccines within 30 days before screening. 7. The participant has an Eastern Cooperative Oncology Group performance status score of \>2. 8. The participant 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 participant has received other B Cell Maturation Antigen (BCMA)\*Cluster of Differentiation (CD3)-directed Bispecific Antibody therapy (BsAb), BCMA-targeted chimeric antigen receptor T-cell (CAR T-cell), or BCMA-targeted antibody drug conjugate (ADC) therapy within 1 year prior to screening. 10. The participant is scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening. 11. The participant may be excluded from the study if, in the opinion of the investigator, the participant is at high risk for symptomatic hyperviscosity syndrome. 12. The participant has major surgery scheduled during the study, or the participant has not fully recovered from a recent major surgery (as judged by the investigator) during screening (participants with planned surgical procedures to be conducted under local anesthesia may participate). 13. The participant has an active secondary (non-MM) malignancy or other medical condition with life-expectancy of less than (\<) 2 years. 14. The participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) after Intravenous Immunoglobulin (IVIG) and/or immune serum globulin infusions. 15. The participant 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 participant has moderate to severe renal dysfunction based on an estimated glomerular filtration rate less than (\<) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2), 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 participant has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen, Polymerase Chain Reaction (PCR) for hepatitis C virus, PCR for Human Immunodeficiency Virus (HIV) Type 1 and Type 2. Cured participants with a history of hepatitis C infection who have a negative PCR test at screening are eligible. 18. The participant has a documented diagnosis of a form of primary immunodeficiency (PID) involving a defect in antibody formation and requiring IgG replacement, as defined according to the International Union of Immunological Societies Committee. 19. The participant has a persistent serum aspartate aminotransferase and alanine aminotransferase \>3.0 times the upper limit of normal (ULN) at screening (may be repeated once to determine if it is persistent). 20. The participant has an immunoglobulin A (IgA) deficiency (\<0.07 grams per liter \[g/L\]) with antibodies to IgA and a history of hypersensitivity reaction to IVIG. 21. Participant 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 participant 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 participant 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 participant at undue medical risk. 25. The participant is receiving immunosuppressive treatment (other than for MM or corticosteroids) at screening or plans to receive immunosuppressive treatment after study enrollment. 26. The participant is not willing and able to comply with the protocol requirements. 27. The participant has participated or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device within 30 days before screening and during the course of the study. 28. The participant is a family member or employee of the investigator or the investigator's site staff. 29. The participant is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.

Where Is This Study? (6 UK sites)

Royal Devon And Exeter Hospital

Exeter EX2 5DH, United Kingdom

Recruiting
Site contact (verified)
Loretta NguPrincipal Investigator

Colchester General Hospital

Colcester CO4 5JL, United Kingdom

Recruiting
Site contact (verified)
Khalid SajaPrincipal Investigator

Gloucestershire Royal Hospital

Gloucester GL1 3NN, United Kingdom

Recruiting
Site contact (verified)
Asha JohnyPrincipal Investigator

Cardiff & Vale University Health Board

Cardiff CF14 4XU, United Kingdom

Recruiting
Site contact (verified)
Ceri BygravePrincipal Investigator

Milton Keynes University Hospital NHS Foundation Trust

Milton Keynes MK6 5LD, United Kingdom

Recruiting
Site contact (verified)
Kunaal KaushikPrincipal Investigator

County Hospital (Stafford Hospital)

Stafford ST16 3SA, United Kingdom

Recruiting
Site contact (verified)
Kamaraj KarunanithiPrincipal Investigator

How to Get in Touch

Takeda Contact

Sponsor contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09