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NCT05879757 | RECRUITING | Multiple Myeloma

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

Takeda

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.

Condition or disease

Multiple Myeloma

Secondary Immunodeficiency (SID)

Intervention/treatment

No Intervention

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 Latin American countries. The overall time of this study is 38 months. Participants will make multiple visits to the clinic 12 days after last dose of study drug for a follow-up assessment.

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
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)
Actual Study Start Date : 2023-10-17
Estimated Primary Completion Date : 2025-07-01
Estimated Study Completion Date : 2026-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • Participants who meet all of the following criteria assessed at the time of enrollment are eligible for this study
    • 1. Has a diagnosis of MM requiring systemic anti-myeloma therapy as per International Myeloma Working Group (IMWG) criteria
    • 2. 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).
    • 3. Age ≥18 years old at the time of MM diagnosis
    • 4. Available medical history records starting from the diagnosis of MM requiring systemic anti-myeloma therapy as IMWG criteria
    • 5. Life expectancy \>6 months at the time of enrollment, per physician assessment
    • 6. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2
    • 7. 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 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
      • 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, with concurrence with the Sponsor's medical monitor, 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.
Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency

Location Details

NCT05879757

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

Argentina,

Clinical Research Center Cordoba

Cordoba, Argentina, X5000AAW

NOT YET RECRUITING

Czechia,

University Hospital Pilsen

Pilsen, Czechia, 32300

NOT YET RECRUITING

Czechia,

General Faculty Hospital

Prague 2, Czechia, 128 08

NOT YET RECRUITING

France,

UH Amiens CEDEX 1

Amiens Cedex 1, France, 80054

NOT YET RECRUITING

France,

Dijon University Hospital - Bocage Hospital

Dijon, France, 21000

NOT YET RECRUITING

France,

Confluent Private Hospital

Nantes, France, 44 000

NOT YET RECRUITING

France,

Source Hospital - CHR Orleans

Orleans, France, 45100

NOT YET RECRUITING

France,

Bordeaux University Hospital - Haut-Leveque Hospital

Pessac, France, 33604

NOT YET RECRUITING

Germany,

MHP-Muenchner Haematologiepraxis

Berlin, Germany, 10117

RECRUITING

Greece,

Alexandra General Hospital

Athens, Greece, 11528

NOT YET RECRUITING

Greece,

C. Papanicolaou Hospital

Thessaloniki, Greece, 57010

NOT YET RECRUITING

Italy,

A.O.U.C Polyclinic of Bari

Bari, Italy, 70124

NOT YET RECRUITING

Italy,

AOU Policlinico Rodolico San Marco

Catania, Italy, 95124

NOT YET RECRUITING

Italy,

Padua University Hospital Company

Padova, Italy, 35128

NOT YET RECRUITING

Italy,

University of Padova

Treviso, Italy, 31100

NOT YET RECRUITING

Poland,

Lubin Region St. Jan of Dukla

Lublin, Poland, 20-090

NOT YET RECRUITING

Romania,

Fundeni Clinical Institute

Bucharest, Romania, 22328

NOT YET RECRUITING

Romania,

Ion Chiricuta Oncology Institute

Cluj-Napoca, Romania, 400124

NOT YET RECRUITING

Romania,

Philanthropia Craiova Municipal Clinical Hospital

Craiova, Romania, 200143

NOT YET RECRUITING

Romania,

Clinical Emergency Hospital Sibiu

Sibiu, Romania, 550166

NOT YET RECRUITING

Spain,

San Carlos Clinical Hospital

Madrid, Spain, 28040

NOT YET RECRUITING

Spain,

October 12th

Madrid, Spain, 28041

NOT YET RECRUITING

Spain,

Son Espases University Hospital

Palma, Spain, 7020

NOT YET RECRUITING

Sweden,

SUS, Lund

Lund, Sweden, SE-221 85

NOT YET RECRUITING

Sweden,

Uppsala University of Applied Sciences

Uppsala, Sweden, 75185

NOT YET RECRUITING

Turkey,

Ankara University

Ankara, Turkey, 6620

NOT YET RECRUITING

Turkey,

Antalya Training and Research Hospital

Antalya, Turkey, 7100

NOT YET RECRUITING

Turkey,

Istanbul University

Istanbul, Turkey, 34098

NOT YET RECRUITING

Turkey,

Medipol Istanbul University

Istanbul, Turkey, 34214