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Multiple MyelomaNCT05879757

Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency

An observational study of Multiple Myeloma and Secondary Immunodeficiency (SID), run by Takeda at 27 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

In this study, multiple myeloma participants with secondary immunodeficiency (SID) will be treated with HyQvia according to their clinic's standard practice. The study's main aim is to look into infusion parameters of HyQvia administration. Read more about this study

Who is it for?
Ages 18 years and older
How many people
75 participants
Where
27 sitesin 11 countries
Study dates
17 Oct 2023to 16 Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Participants who meet all of the following criteria assessed at the time of enrollment are eligible for this study:
  • Ability and willingness to provide informed consent. For adult participants unable to provide informed consent, informed consent provided by the legally authorized representative (LAR).
  • Has a diagnosis of MM requiring systemic anti-myeloma therapy as per International Myeloma Working Group (IMWG) criteria.
  • 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).
  • Age >=18 years old at the time of MM diagnosis.
Show all 10Show fewer
  • Available medical history records starting from the diagnosis of MM requiring systemic anti-myeloma therapy as IMWG criteria.
  • Life expectancy >6 months at the time of enrollment, per physician assessment.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of <=2.
  • Participants/LAR willing and able to comply with the requirements of the protocol.

Who cannot join

  • Participants who meet any of the following criteria assessed at the time of enrollment are not eligible for this study:
  • Known hypersensitivity to any of the components of HyQvia.
  • 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.
  • Prior use of Ig treatment or prophylaxis within 3 months from the date of enrollment.
  • Serious infection(s) requiring intravenous (IV) treatment at the time of enrollment into the study; except for participants on short-term oral antibiotic therapy.
  • 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.
Show all 11Show fewer
  • Note: Participants on investigational chimeric antigen receptor-T (CAR-T) cell therapies and/or bispecific antibodies may participate.
  • 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.
  • 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).
  • 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.

Trial locations and contacts

27 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

27 sites in 11 countries

France5 sites, 5 recruiting

  • CHU Dijon - Hopital du Bocage

    Dijon, 21079

    Site Contact, +33380294506, mlchretien@icb-cancer.fr

    Marie-Lorraine Chretien

    Not yet recruiting

  • Hopital Prive du Confluent

    Nantes, 44 277

    Site Contact, +33243479499, katell.ledu@groupeconfluent.fr

    Katell Le Du

    Recruiting

  • Hopital de la Source - CHR Orleans

    Orléans, 45067

    Site Contact, 33783172531, omar.benbrahim@chr-orleans.fr

    Omar Benbrahim

    Not yet recruiting

  • CHU Bordeaux - Hopital Haut-Leveque

    Pessac, 33604

    Site Contact, 33557656483, jean-francois.viallard@chu-bordeaux.fr

    Jean-Francois Viallard

    Not yet recruiting

  • CHU Amiens - Hopital Sud

    Salouël, Somme, 80480

    Site Contact, +33322455914, gourguechon.clement@chu-amiens.fr

    Clement Gourguechon

    Recruiting

Other trials in France

Italy4 sites, 4 recruiting

  • A.O.U.C Policlinico di Bari

    Bari, 70124

    Site Contact, +390805478057, angelo.vacca@uniba.it

    Angelo Vacca

    Recruiting

  • AOU Policlinico Rodolico San Marco

    Catania, 95125

    Site Contact, +39953782971, sandrina.romano@gmail.co

    Alessandra Romano

    Recruiting

  • Azienda Ospedale Universita Padova

    Padova, 35128

    Site Contact, +39498217809, tamara.berno@aopd.veneto.it

    Tamara Berno

    Not yet recruiting

  • University of Padova

    Treviso, 31122

    Site Contact, +390422328145, francesco.cinetto@unipd.it

    Francesco Cinetto

    Recruiting

Other trials in Italy

Romania4 sites, 4 recruiting

  • Spitalul Clinic Colentina

    Bucharest, 020125

    Site Contact, +40044559730, tevetmihaela@gmail.com

    Mihaela Andreescu

    Not yet recruiting

  • Institutul Clinic Fundeni

    Bucharest, 22328

    Site Contact, 40724238956, sorinabadelita@gmail.com

    Sorina Badelita

    Not yet recruiting

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

    Cluj-Napoca, 400015

    Site Contact, 40741337480, ciprian.tomuleasa@umfcluj.ro

    Ciprian Tomuleasa

    Not yet recruiting

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, 200143

    Site Contact, 40735439439, diaconu_luminita@yahoo.com

    Luminita Ocroteala

    Not yet recruiting

Other trials in Romania

Spain3 sites, 3 recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Site Contact, +34913303001, ssramon@salud.madrid.org

    Silvia Sanchez-Ramon

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Site Contact, +34913908619, j.martinez@salud.madrid.org

    Joaquin Martinez-Lopez

    Recruiting

  • Hospital Universitari Son Espases

    Palma, 70120

    Site Contact, +34871206268, albert.perez@ssib.es

    Albert Perez-Montana

    Recruiting

Other trials in Spain

Turkey (Türkiye)3 sites, 3 recruiting

  • Ankara University Medical Faculty

    Ankara, 06100

    Site Contact, +903125957100, sktoprak@yahoo.com

    Selami Toprak

    Recruiting

  • Antalya Training and Research Hospital

    Antalya, 7100

    Site Contact, +902422494400, dr_v_karakus@yahoo.com

    Volkan Karakus

    Recruiting

  • Istanbul Universitesi

    Istanbul, 34098

    Site Contact, +902124143280, mcemar68@yahoo.com

    Muhlis Cem Ar

    Not yet recruiting

Other trials in Turkey (Türkiye)

Czechia2 sites, 2 recruiting

  • Fakultni nemocnice Plzen

    Pilsen, 30460

    Site Contact, +420224962568, jungovaa@fnplzen.cz

    Alexandra Jungova

    Recruiting

  • Vseobecna fakultni Nemocnice

    Prague, 128 08

    Site Contact, +420224962568, straub@vfn.cz

    Jan Straub

    Not yet recruiting

Other trials in Czechia

Greece2 sites, 2 recruiting

  • Alexandra General Hospital

    Athens, 11528

    Site Contact, +302106995763, ekastritis@gmail.com

    Efstathios Kastritis

    Recruiting

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57010

    Site Contact, +302313307533, ioannamarilena@gmail.com

    Ioanna Sakellari

    Recruiting

Other trials in Greece

Argentina1 site

  • Instituto Privado de Investigaciones Clinicas de Cordoba

    Córdoba, X5000AAW

    Withdrawn

Other trials in Argentina

Germany1 site, 1 recruiting

  • MHP-Muenchner Haematologiepraxis

    Berlin, 10117

    Site Contact, 498999017260, schabath@onkologie-berlin-mitte.de

    Richard Schabath

    Not yet recruiting

Other trials in Germany

Poland1 site, 1 recruiting

  • Pomorski Uniwersytet Medyczny

    Szczecin, 71252

    Site Contact, +48924250428, boguslaw.machalinski@pum.edu.pl

    Boguslaw Machalinski

    Recruiting

Other trials in Poland

Sweden1 site, 1 recruiting

  • Lund University Hospital

    Lund, SE-221 85

    Site Contact, 4646171130, goran.b.jonsson@skane.se

    Goran Jonsson

    Not yet recruiting

Other trials in Sweden

About this study

Official title: A Prospective, Observational Study to Assess the Real-World Usage and Outcomes of HyQvia in Patients With Multiple Myeloma (MM) Diagnosed With Secondary Immunodeficiency (SID)

In this study, multiple myeloma participants with secondary immunodeficiency (SID) will be treated with HyQvia according to their clinic's standard practice. The study's main aim is to look into infusion parameters of HyQvia administration.

Read the detailed description

This is a prospective, observational study of adults having multiple myeloma (MM) with SID treated with HyQvia as part of routine clinical care. This study will characterize the real-world infusion parameters of HyQvia administration.

The study will enroll approximately 100 participants.

Study data will be requested through participants' routine clinic visits and patient-reported outcome (PRO)s are voluntary.

This multi-center trial will be conducted in selected European and South American countries. The overall time of this study is 38 months. Participants will make multiple visits to the clinic within 12 months after enrolment for follow-up assessments.

Being tested
No Intervention
Keywords
Drug Therapy, Supportive Therapy
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    As this is an observational study, no intervention will be administered in this study.

Study groups in NCT05879757
Study groupRoleWhat they receive
MM Participants With SIDParticipants with MM diagnosed with SID will be treated with HyQvia as part of routine clinical care and will be followed prospectively from the date of starting HyQvia treatment through 12 months of follow-up.
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose of HyQvia per Kilogram of Body Weight

    Dose of HyQvia will be calculated as grams per kilogram (g/kg) body weight per 4 weeks.

    Measured: Up to 12 months

  2. Absolute Dose of HyQvia per Infusion

    Absolute dose of HyQvia will be calculated as dose per infusion in milligrams (mg).

    Measured: Up to 12 months

  3. Treatment Interval

    Treatment interval and ramp up dosing intervals will be reported as Weekly, every 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks and other administration according to the schedule defined by physician.

    Measured: Up to 12 months

  4. Infusion Volume per Site

    Measured: Up to 12 months

  5. Total Infusion Volume

    Measured: Up to 12 months

  6. Infusion Rate

    Infusion rate will be reported in milliliters per hour (mL/h).

    Measured: Up to 12 months

  7. Duration of Infusion

    The duration between start and end of infusion will be reported.

    Measured: Up to 12 months

  8. Location of Infusion Sites

    Location of infusion sites will include right upper abdomen, left upper abdomen, right lower abdomen, left lower abdomen, right or left thigh, right or left arm, and other (specified).

    Measured: Up to 12 months

  9. Number of Infusion Sites

    Measured: Up to 12 months

  10. Number of Participants Characterized by Site of Care

    Site of care will be categorized as home, hospital, doctor's office, other (specified).

    Measured: Up to 12 months

  11. Length and Diameter of Infusion Needles

    Measured: Up to 12 months

  12. Number of Participants per Type of Pump

    Type of pump will include peristaltic infusion pump and syringe driver pump.

    Measured: Up to 12 months

  13. Number of Participants With Availability of Caregiver Support

    Availability of caregiver support will be collected as yes, no, and unknown. If yes, caregiver relationship will be specified.

    Measured: Up to 12 months

  14. Number of Training Visits

    Measured: Up to 12 months

  15. Number of Participants With Infusions That are Discontinued, Slowed, or Interrupted

    Measured: Up to 12 months

  16. Number of Participants With Reasons of infusions Discontinued, Slowed, or Interrupted

    Measured: Up to 12 months

  17. Number of Participants With Reasons for Discontinued, or Interrupted HyQvia Treatment or Switches to Other Treatment

    Reasons for discontinued, or interrupted HyQvia treatment will include local adverse events (AE)/discomfort, systemic AE, administration complexity, insurance/reimbursement-related, low immunoglobulin (Ig) trough level, lack of effectiveness, inability to tolerate large volumes, death and other (specified). If switch, type of treatment after switch (example, antibiotic treatment, intravenous immunoglobulin [IVIg], subcutaneous immunoglobulin [SCIg], unknown) or switches to other treatment will be included.

    Measured: Up to 12 months

Secondary outcomes (11)

  1. Time of Multiple Myeloma (MM) Diagnosis

    Measured: At the time of baseline

  2. Number of Participants Characterized by Clinical Characteristics

    Clinical characteristics of participants will include type of MM, and MM treatment/procedures, comorbidities, concomitant medications, laboratory tests and imaging.

    Measured: Up to 12 months

  3. Number of Participants Characterized With Type of Hemato-oncological Treatment

    Type of hemato-oncological treatment will list type, switches, interruptions and discontinuation with reasons of hemato-oncological treatment or procedure.

    Measured: Baseline up to 12 months

  4. Duration of Hemato-oncological Treatment

    Measured: Baseline up to 12 months

  5. Number of Participants With Multiple Myeloma (MM) Disease Status and Outcome at 12 Months

    MM disease status and outcome will include response and criteria used to assess response (if known).

    Measured: Month 12

  6. Overall Survival (OS)

    OS will be summarized as the frequency and percentage of participants surviving to each follow-up visit. Additionally, time-to death, defined as the time from HyQvia initiation to death occurring before the end of the study period, will be assessed.

    Measured: Up to 12 months

  7. Number of Participants With Healthcare Resource Utilization (HCRU)

    Number of participants with HCRU including annualized rates and emergency room visits, urgent care visits, outpatient visits, telemedicine visits, and other physician visits, with stratification of hospitalizations and visits due to infection, visit type and provider type.

    Measured: Up to 12 months

  8. Duration of Hospitalizations

    Measured: Up to 12 months

  9. Number of Participants With Related and Not Related Serious Adverse Events (SAEs)

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence that at any dose is fatal, life-threatening, requires inpatient hospitalisation or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. AEs will be reported as local or systemic AEs.

    Measured: Up to 12 months

  10. Number of Participants With Non-serious Adverse Events (AEs) Causally or Temporally Related to HyQvia Treatment

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AEs will be reported as local or systemic AEs.

    Measured: Up to 12 months

  11. Number of Participants With Premedication use for HyQvia Infusions, any Technical Problems With the Infusion, and the Planned Versus Actual Dosing

    Premedication use for HyQvia infusions will include start date, stop date and medication name. Technical problems with infusion will include problems with the handling of the pump, problems with the preparation of the infusion, problems with the infusion itself, infusion site leakage, and other (specified).

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start17 Oct 2023
  3. Primary completion16 Feb 2027 (estimated)
  4. Study completion16 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05879757
Sponsor's protocol ID
TAK-771-5006
Status last verified
Feb 2026
First submitted
19 May 2023
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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?commitment=5). 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma and Secondary Immunodeficiency (SID), run by Takeda at 27 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in France, Italy, Romania, Spain, Turkey (Türkiye) and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose of HyQvia per Kilogram of Body Weight (time frame: Up to 12 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05879757.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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