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Can an immune boost keep myeloma patients Infection-Free on powerful new drugs?

NCT ID NCT06980480

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This Phase 3 trial tests whether giving immune globulin (IGI) regularly can prevent serious infections in adults with multiple myeloma who are receiving a bispecific antibody therapy. About 183 participants will be randomly assigned to get IGI right away for 12 months or only after a serious infection occurs. The study aims to see if early, routine use of IGI reduces the number of serious infections compared to waiting until an infection happens.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Immune globulin infusion (10%)
What this could lead to
If it works, this could provide a standard way to prevent serious infections in multiple myeloma patients on bispecific antibody therapy.
What could go wrong
This is a Phase 3 trial, but it only compares two prevention strategies, not a placebo. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 183 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma Secondary immunodeficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    56 sites in 16 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • A O Krankenhaus der Elisabethinen

    RECRUITING

    Linz, 4020, Austria

  • Aalborg Hospital

    RECRUITING

    Aalborg, 9000, Denmark

  • Aarhus Universitetshospital

    RECRUITING

    Aarhus, DK-820, Denmark

  • Aidport sp. z o.o.

    RECRUITING

    Skorzewo, 60-185, Poland

  • Alexandra General Hospital of Athens

    RECRUITING

    Athens, 105 57, Greece

  • Amsterdam University Medical Center (Amsterdam UMC)

    RECRUITING

    Amsterdam, 1019PE, Netherlands

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    RECRUITING

    Roma, 161, Italy

  • Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco

    RECRUITING

    Catania, 95124, Italy

  • Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica

    RECRUITING

    Torrette, 60126, Italy

  • Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo

    RECRUITING

    Pescara, 65125, Italy

  • Cancer Care Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Cardiff & Vale University Health Board

    RECRUITING

    Cardiff, South Glamorgan, CF14 4XU, United Kingdom

  • Centre Hospitalier de l'Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Chao Family Comprehensive Cancer Center UCI

    RECRUITING

    Orange, California, 92868, United States

  • Colchester General Hospital

    RECRUITING

    Colcester, Essex, CO4 5JL, United Kingdom

  • Colentina Clinical Hospital

    RECRUITING

    Bucharest, 020125, Romania

  • Complejo Asistencial Universitario de Salamanca - H. Clinico

    RECRUITING

    Salamanca, 37007, Spain

  • Copenhagen University Hospital

    RECRUITING

    Copenhagen, 2100, Denmark

  • County Hospital (Stafford Hospital)

    RECRUITING

    Stafford, ST16 3SA, United Kingdom

  • Fakultni Nemocnice Ostrava (FNO) - Neurologicke klinika

    RECRUITING

    Ostrava, 70800, Czechia

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    RECRUITING

    Pavia, 27100, Italy

  • Gloucestershire Royal Hospital

    RECRUITING

    Gloucester, Gloucestershire, GL1 3NN, United Kingdom

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Costa Del Sol

    RECRUITING

    Marbella, 29603, Spain

  • Hospital Universitari Son Espases (HUSE) (Hospital Universitario Son Dureta) (HUSD)

    RECRUITING

    Palma de Mallorca, 07120, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Infirmary Health - Diagnostic & Medical Clinic (DMC)

    RECRUITING

    Mobile, Alabama, 36604, United States

  • Instituto D'Or de Pesquisa e Ensino

    RECRUITING

    Salvador, 41253-190, Brazil

  • Instituto D'Or de Pesquisa e Ensino - Sao Paulo

    RECRUITING

    São Paulo, 01401-002, Brazil

  • Instituto Oncoclínicas de Ensino

    RECRUITING

    Rio de Janeiro, 22250040, Brazil

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    RECRUITING

    Cluj-Napoca, 400015ro, Romania

  • Krankenhaus der Barmherzigen Schwestern Wien

    RECRUITING

    Vienna, 1060, Austria

  • Markusovszky Egyetemi Oktatokorhaz

    RECRUITING

    Szombathely, 9700, Hungary

  • Milton Keynes University Hospital NHS Foundation Trust

    RECRUITING

    Milton Keynes, MK6 5LD, United Kingdom

  • New York Oncology Hematology

    RECRUITING

    Albany, New York, 12208, United States

  • Odense Universitetshospital

    RECRUITING

    Odense, 5000, Denmark

  • Royal Devon And Exeter Hospital

    RECRUITING

    Exeter, Devon, EX2 5DH, United Kingdom

  • Sao Jose do Rio Preto Regional Faculty of Medicine FoundationSao Jose do Rio Preto Regional Faculty of Medicine Foundation

    RECRUITING

    Porto Alegre, 90110-270, Brazil

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    RECRUITING

    Kaposvár, 7400, Hungary

  • Spitalul Municipal Filantropia Craiova

    RECRUITING

    Craiova, 200143, Romania

  • St George Private Hospital

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • St Vincents Hospital Melbourne

    RECRUITING

    Melbourne, 3065, Australia

  • St. Antonius Ziekenhuis

    RECRUITING

    Nieuwegein, 3435, Netherlands

  • St.Olavs Hospital

    RECRUITING

    Trondheim, 7491, Norway

  • Townsville Hospital

    RECRUITING

    Douglas, Queensland, 4814, Australia

  • Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O)

    RECRUITING

    Madrid, 28041, Spain

  • Universitaetsklinikum St. Poelten

    RECRUITING

    Sankt Pölten, 3100, Austria

  • University General Hospital of Ioannina

    RECRUITING

    Ioannina, 45500, Greece

  • University of Kansas

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Maryland | Greenebaum Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Uniwersyteckie Centrum Kliniczne - Ul. Smoluchowskiego 17

    RECRUITING

    Gdansk, 80-214, Poland

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Western Health - Sunshine Hospital

    RECRUITING

    St Albans, Victoria, 3021, Australia

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