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Real-World study tracks HyQvia use in myeloma patients with weakened immunity

NCT ID NCT05879757

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study follows 75 multiple myeloma patients with secondary immunodeficiency who are receiving HyQvia as part of their routine care. Researchers will collect data on infusion details like dose, rate, and site, as well as any reasons for stopping or switching treatment. The goal is to understand how HyQvia is used in real-world settings, not to test a new treatment.

What this could mean

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

Active substance
HyQvia (immune globulin infusion 10% with recombinant human hyaluronidase)
What this could lead to
If successful, this study could provide practical guidance on how to best administer HyQvia to multiple myeloma patients with weakened immune systems.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may vary across different clinics and patient groups.

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.

Participants

About 75 people

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

Started

Oct 2023

Expected to finish

Feb 2027

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.

Who is studied

The study population will include adult participants who suffer from MM, have a diagnosis of SID defined according to the European HyQvia label.

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: Participants who meet all of the following criteria assessed at the time of enrollment are eligible for this study: 1. Ability and willingness to provide informed consent. For adult participants unable to provide informed consent, informed consent provided by the legally authorized representative (LAR). 2. Has a diagnosis of MM requiring systemic anti-myeloma therapy as per International Myeloma Working Group (IMWG) criteria. 3. Initiated HyQvia treatment as part of routine clinical care no more than 30 days before study enrollment or received no more than 2 doses of HyQvia treatment, whichever occurs first. Participants are also eligible if they newly start HyQvia within 30 days after the enrollment visit. Note: Participants who do not start HyQvia treatment within 30 days of enrollment will be considered as screen failures (and replaced). 4. Age \>=18 years old at the time of MM diagnosis. 5. Available medical history records starting from the diagnosis of MM requiring systemic anti-myeloma therapy as IMWG criteria. 6. Life expectancy \>6 months at the time of enrollment, per physician assessment. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of \<=2. 8. Participants/LAR willing and able to comply with the requirements of the protocol. Exclusion Criteria: Participants who meet any of the following criteria assessed at the time of enrollment are not eligible for this study: 1. Known hypersensitivity to any of the components of HyQvia. 2. Primary immunodeficiency (PID) or diagnosed with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) and/or active hepatitis C and/or active hepatitis B infection. 3. Prior use of Ig treatment or prophylaxis within 3 months from the date of enrollment. 4. Serious infection(s) requiring intravenous (IV) treatment at the time of enrollment into the study; except for participants on short-term oral antibiotic therapy. 5. Has participated in an interventional clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in an interventional clinical study involving a medical product or device during this study. Note: Participants on investigational chimeric antigen receptor-T (CAR-T) cell therapies and/or bispecific antibodies may participate. 6. Planned stem cell transplant during the treatment period or had a prior stem cell transplant: allogeneic transplant at any time, autologous transplant within 3 months of enrollment. 7. History of malignancy (other than MM) within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, localized prostate cancer or other non-invasive lesion that in the opinion of the investigator, is considered cured with minimal risk of recurrence within 3 years). 8. Participant has had major surgery within 2 weeks before enrollment, or has not fully recovered from an earlier surgery, or has surgery planned during the time the participant is expected to participate in the study. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma Secondary immunodeficiency (SID)

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

    26 sites in 10 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.U.C Policlinico di Bari

    RECRUITING

    Bari, 70124, Italy

  • AOU Policlinico Rodolico San Marco

    RECRUITING

    Catania, 95125, Italy

  • Alexandra General Hospital

    RECRUITING

    Athens, 11528, Greece

  • Ankara University Medical Faculty

    RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • Antalya Training and Research Hospital

    RECRUITING

    Antalya, 7100, Turkey (Türkiye)

  • Azienda Ospedale Universita Padova

    NOT_YET_RECRUITING

    Padova, 35128, Italy

  • CHU Amiens - Hopital Sud

    RECRUITING

    Salouël, Somme, 80480, France

  • CHU Bordeaux - Hopital Haut-Leveque

    NOT_YET_RECRUITING

    Pessac, 33604, France

  • CHU Dijon - Hopital du Bocage

    NOT_YET_RECRUITING

    Dijon, 21079, France

  • Fakultni nemocnice Plzen

    RECRUITING

    Pilsen, 30460, Czechia

  • General Hospital of Thessaloniki "G. Papanikolaou"

    RECRUITING

    Thessaloniki, 57010, Greece

  • Hopital Prive du Confluent

    RECRUITING

    Nantes, 44 277, France

  • Hopital de la Source - CHR Orleans

    NOT_YET_RECRUITING

    Orléans, 45067, France

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitari Son Espases

    RECRUITING

    Palma, 70120, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Instituto Privado de Investigaciones Clinicas de Cordoba

    WITHDRAWN

    Córdoba, X5000AAW, Argentina

  • Institutul Clinic Fundeni

    NOT_YET_RECRUITING

    Bucharest, 22328, Romania

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

    NOT_YET_RECRUITING

    Cluj-Napoca, 400015, Romania

  • Istanbul Universitesi

    NOT_YET_RECRUITING

    Istanbul, 34098, Turkey (Türkiye)

  • Lund University Hospital

    NOT_YET_RECRUITING

    Lund, SE-221 85, Sweden

  • MHP-Muenchner Haematologiepraxis

    NOT_YET_RECRUITING

    Berlin, 10117, Germany

  • Pomorski Uniwersytet Medyczny

    RECRUITING

    Szczecin, 71252, Poland

  • Spitalul Clinic Colentina

    NOT_YET_RECRUITING

    Bucharest, 020125, Romania

  • Spitalul Clinic Municipal Filantropia Craiova

    NOT_YET_RECRUITING

    Craiova, 200143, Romania

  • University of Padova

    RECRUITING

    Treviso, 31122, Italy

  • Vseobecna fakultni Nemocnice

    NOT_YET_RECRUITING

    Prague, 128 08, Czechia

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