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

NCT05879757 | Recruiting

• 1 other identifier: TAK-771-5006
• Study Type: observational
• Target: 75
• Locations: 11 countries
• Sites: 27

Brief 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.

Conditions

Multiple Myeloma; Secondary Immunodeficiency (SID)

Keywords

Drug Therapy; Supportive Therapy

Outcome Measures

Primary Outcomes (17)

• 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.

  Up to 12 months

• Absolute Dose of HyQvia per Infusion

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

  Up to 12 months

• 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.

  Up to 12 months

• Infusion Volume per Site

  Up to 12 months

• Total Infusion Volume

  Up to 12 months

• Infusion Rate

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

  Up to 12 months

• Duration of Infusion

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

  Up to 12 months

• 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).

  Up to 12 months

• Number of Infusion Sites

  Up to 12 months

• Number of Participants Characterized by Site of Care

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

  Up to 12 months

• Length and Diameter of Infusion Needles

  Up to 12 months

• Number of Participants per Type of Pump

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

  Up to 12 months

• 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.

  Up to 12 months

• Number of Training Visits

  Up to 12 months

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

  Up to 12 months

• Number of Participants With Reasons of infusions Discontinued, Slowed, or Interrupted

  Up to 12 months

• 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.

  Up to 12 months

Secondary Outcomes (11)

• Time of Multiple Myeloma (MM) Diagnosis

  At the time of baseline

• Number of Participants Characterized by Clinical Characteristics

  Up to 12 months

• Number of Participants Characterized With Type of Hemato-oncological Treatment

  Baseline up to 12 months

• Duration of Hemato-oncological Treatment

  Baseline up to 12 months

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

  Month 12

Study Arms (1)

MM Participants With SID

Participants 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.

Other: No Intervention

Interventions

No Intervention OTHER

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

MM Participants With SID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (27)

Instituto Privado de Investigaciones Clinicas de Cordoba

Córdoba, X5000AAW, Argentina

WITHDRAWN

Fakultni nemocnice Plzen

Pilsen, 30460, Czechia

RECRUITING

Vseobecna fakultni Nemocnice

Prague, 128 08, Czechia

NOT YET RECRUITING

CHU Amiens - Hopital Sud

Salouël, Somme, 80480, France

RECRUITING

CHU Dijon - Hopital du Bocage

Dijon, 21079, France

NOT YET RECRUITING

Hopital Prive du Confluent

Nantes, 44 277, France

RECRUITING

Hopital de la Source - CHR Orleans

Orléans, 45067, France

NOT YET RECRUITING

CHU Bordeaux - Hopital Haut-Leveque

Pessac, 33604, France

NOT YET RECRUITING

MHP-Muenchner Haematologiepraxis

Berlin, 10117, Germany

NOT YET RECRUITING

Alexandra General Hospital

Athens, 11528, Greece

RECRUITING

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, 57010, Greece

RECRUITING

A.O.U.C Policlinico di Bari

Bari, 70124, Italy

RECRUITING

AOU Policlinico Rodolico San Marco

Catania, 95125, Italy

RECRUITING

Azienda Ospedale Universita Padova

Padua, 35128, Italy

NOT YET RECRUITING

University of Padova

Treviso, 31122, Italy

RECRUITING

Pomorski Uniwersytet Medyczny

Szczecin, 71252, Poland

RECRUITING

Spitalul Clinic Colentina

Bucharest, 020125, Romania

NOT YET RECRUITING

Institutul Clinic Fundeni

Bucharest, 22328, Romania

NOT YET RECRUITING

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015, Romania

NOT YET RECRUITING

Spitalul Clinic Municipal Filantropia Craiova

Craiova, 200143, Romania

NOT YET RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitari Son Espases

Palma, 70120, Spain

RECRUITING

Lund University Hospital

Lund, SE-221 85, Sweden

NOT YET RECRUITING

Ankara University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Antalya Training and Research Hospital

Antalya, 7100, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi

Istanbul, 34098, Turkey (Türkiye)

NOT YET RECRUITING

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 30, 2023
• Study Start: October 17, 2023
• Primary Completion (Estimated): February 16, 2027
• Study Completion (Estimated): February 16, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

IT (4); FR (5); AR (1); CZ (2); GR (2); PL (1); ES (3); TU (3); DE (1); SE (1); RO (4)