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

Multiple Myeloma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879757
• Other study ID #: TAK-771-5006
• Status: Recruiting
• Start date: October 17, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: October 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Multiple Myeloma
• Neoplasm Metastasis
• Neoplasms, Plasma Cell
• Secondary Immunodeficiency (SID)

Intervention

Other:
• No Intervention
As this is an observational study, no intervention will be administered in this study.

Locations

Country	Name	City	State
Argentina	Centro de investigaciones Clinicas Cordoba	Cordoba
Czechia	Fakultni nemocnice Plzen	Pilsen
Czechia	Vseobecna fakultni Nemocnice	Praha 2
France	UH Amiens CEDEX 1	Amiens Cedex 1
France	CHU Dijon - Hopital du Bocage	Dijon
France	Hopital Prive du Confluent	Nantes
France	Hopital de la Source - CHR Orleans	Orleans
France	CHU Bordeaux - Hopital Haut-Leveque	Pessac
Germany	MHP-Muenchner Haematologiepraxis	Berlin
Greece	Alexandra General Hospital	Athens
Greece	G. Papanikolaou Hospital	Thessaloniki
Italy	A.O.U.C Policlinico di Bari	Bari
Italy	AOU Policlinico Rodolico San Marco	Catania
Italy	Azienda Ospedale Universita Padova	Padova
Italy	University of Padova	Treviso
Poland	Lubin Region St. Jana z Dukli	Lublin
Romania	Institutul Clinic Fundeni	Bucharest
Romania	Ion Chiricuta Oncology Institute	Cluj Napoca
Romania	Spitalul Clinic Municipal Filantropia Craiova	Craiova
Romania	Clinical Emergency Hospital Sibiu	Sibiu
Spain	H12 de Octubre	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitari Son Espases	Palma
Sweden	SUS, Lund	Lund
Sweden	Uppsala UH	Uppsala
Turkey	Ankara University	Ankara
Turkey	Antalya Training and Research Hospital	Antalya
Turkey	Istanbul Universitesi	Istanbul
Turkey	Medipol Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Argentina,  Czechia,  France,  Germany,  Greece,  Italy,  Poland,  Romania,  Spain,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Absolute Dose of HyQvia per Infusion	Absolute dose of HyQvia will be calculated as dose per infusion in milliliters (mL).	Up to 12 months
Primary	Treatment Interval	Treatment interval and ramp up dosing intervals will be reported as Weekly, every 2 weeks, 3 weeks, 4 weeks and other administration according to the schedule defined by physician.	Up to 12 months
Primary	Infusion Volume per Site		Up to 12 months
Primary	Total Infusion Volume		Up to 12 months
Primary	Infusion Rate	Infusion rate will be reported in milliliters per hour (mL/h).	Up to 12 months
Primary	Duration of Infusion	The duration between start and end of infusion will be reported.	Up to 12 months
Primary	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
Primary	Number of Infusion Sites		Up to 12 months
Primary	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
Primary	Length and Diameter of Infusion Needles		Up to 12 months
Primary	Number of Participants per Type of Pump	Type of pump will include peristaltic infusion pump and syringe driver pump.	Up to 12 months
Primary	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
Primary	Number of Training Visits		Up to 12 months
Primary	Number of Participants With Infusions That are Discontinued, Slowed, or Interrupted		Up to 12 months
Primary	Number of Participants With Reasons of infusions Discontinued, Slowed, or Interrupted		Up to 12 months
Primary	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, lack of efficacy, insurance/reimbursement-related, low immunoglobulin trough level, lack of effectiveness, inability to tolerate large volumes and other (specified). If switch, type of treatment after switch (e.g., antibiotic treatment, intravenous immunoglobulin [IVIg], subcutaneous immunoglobulin [SCIg], etc.) or switches to other treatment will be included.	Up to 12 months
Secondary	Time of Multiple Myeloma (MM) Diagnosis		Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	Duration of Hemato-oncological Treatment		Up to 12 months
Secondary	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).	Month 12
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	Duration of Hospitalizations		Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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. 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.	Up to 12 months
Secondary	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).	Up to 12 months

External Links

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