Trial Title:
Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency
NCT ID:
NCT05879757
Condition:
Multiple Myeloma
Secondary Immunodeficiency (SID)
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
Immunologic Deficiency Syndromes
Conditions: Keywords:
Drug Therapy
Supportive Therapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No Intervention
Description:
As this is an observational study, no intervention will be administered in this study.
Arm group label:
MM Participants With SID
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.
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.
Criteria for eligibility:
Study pop:
The study population will include adult participants who suffer from MM, have a diagnosis
of SID defined according to the European HyQvia label.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centro de investigaciones Clinicas Cordoba
Address:
City:
Cordoba
Zip:
X5000AAW
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
0351 4253456
Email:
eaguilera1981@gmail.com
Investigator:
Last name:
Emanuel Leonardo Aguilera
Email:
Principal Investigator
Facility:
Name:
Fakultni nemocnice Plzen
Address:
City:
Pilsen
Zip:
32300
Country:
Czechia
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
420724875805
Email:
jungovaa@fnplzen.cz
Investigator:
Last name:
Alexandra Jungova
Email:
Principal Investigator
Facility:
Name:
Vseobecna fakultni Nemocnice
Address:
City:
Praha 2
Zip:
128 08
Country:
Czechia
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
420604483698
Email:
jan.straub@vfn.cz
Investigator:
Last name:
Jan Straub
Email:
Principal Investigator
Facility:
Name:
UH Amiens CEDEX 1
Address:
City:
Amiens Cedex 1
Zip:
80054
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
33607378052
Email:
gourguechon.clement@chu-amiens.fr
Investigator:
Last name:
Clement Gourguechon
Email:
Principal Investigator
Facility:
Name:
CHU Dijon - Hopital du Bocage
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
674164672
Email:
mlchretien@icb-cancer.fr
Investigator:
Last name:
Marie-Lorraine Chretien
Email:
Principal Investigator
Facility:
Name:
Hopital Prive du Confluent
Address:
City:
Nantes
Zip:
44 000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
33615246067
Email:
dr.ledu@groupeconfluent.fr
Investigator:
Last name:
Katell Le Du
Email:
Principal Investigator
Facility:
Name:
Hopital de la Source - CHR Orleans
Address:
City:
Orleans
Zip:
45100
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
33783172531
Email:
omar.benbrahim@chr-orleans.fr
Investigator:
Last name:
Omar Benbrahim
Email:
Principal Investigator
Facility:
Name:
CHU Bordeaux - Hopital Haut-Leveque
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
33557656483
Email:
jean-francois.viallard@chu-bordeaux.fr
Investigator:
Last name:
Jean-Francois Viallard
Email:
Principal Investigator
Facility:
Name:
MHP-Muenchner Haematologiepraxis
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
4915121205140
Email:
schabath@onkologie-berlin-mitte.de
Investigator:
Last name:
Richard Schabath
Email:
Principal Investigator
Facility:
Name:
Alexandra General Hospital
Address:
City:
Athens
Zip:
11528
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
6949124743
Email:
mdimop@med.uoa.gr
Investigator:
Last name:
Efstathios Kastritis
Email:
Principal Investigator
Facility:
Name:
G. Papanikolaou Hospital
Address:
City:
Thessaloniki
Zip:
57010
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
302313307516
Email:
ioannamarilena@gmail.com
Investigator:
Last name:
Ioanna Sakellari
Email:
Principal Investigator
Facility:
Name:
A.O.U.C Policlinico di Bari
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+39 080 5593106
Email:
roberto.ria@uniba.it
Investigator:
Last name:
Angelo Vacca
Email:
Principal Investigator
Facility:
Name:
AOU Policlinico Rodolico San Marco
Address:
City:
Catania
Zip:
95124
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
3273971491
Email:
sandrina.romano@gmail.co
Investigator:
Last name:
Alessandra Romano
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedale Universita Padova
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
3498428994
Email:
tamara.berno@aopd.veneto.it
Investigator:
Last name:
Tamara Berno
Email:
Principal Investigator
Facility:
Name:
University of Padova
Address:
City:
Treviso
Zip:
31100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
393929228382
Email:
francesco.cinetto@unipd.it
Investigator:
Last name:
Francesco Cinetto
Email:
Principal Investigator
Facility:
Name:
Lubin Region St. Jana z Dukli
Address:
City:
Lublin
Zip:
20-090
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
48603374080
Email:
poradniaimmu@cozl.eu
Investigator:
Last name:
Jacek Rolinski
Email:
Principal Investigator
Facility:
Name:
Institutul Clinic Fundeni
Address:
City:
Bucharest
Zip:
22328
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
40724238956
Email:
sorinabadelita@gmail.com
Investigator:
Last name:
Sorina Badeelita
Email:
Principal Investigator
Facility:
Name:
Ion Chiricuta Oncology Institute
Address:
City:
Cluj Napoca
Zip:
400124
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
40741337480
Email:
ciprian.tomuleasa@umfcluj.ro
Investigator:
Last name:
Ciprian Tomuleasa
Email:
Principal Investigator
Facility:
Name:
Spitalul Clinic Municipal Filantropia Craiova
Address:
City:
Craiova
Zip:
200143
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
40735439439
Email:
diaconu_luminita@yahoo.com
Investigator:
Last name:
Luminita Ocroteala
Email:
Principal Investigator
Facility:
Name:
Clinical Emergency Hospital Sibiu
Address:
City:
Sibiu
Zip:
550166
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
40730506891
Email:
alinabrabete@yahoo.com
Investigator:
Last name:
Alina Camelia Catana
Email:
Principal Investigator
Facility:
Name:
Hospital Clinico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
34696551658
Email:
ssramon@salud.madrid.org
Investigator:
Last name:
Silvia Sanchez-Ramon
Email:
Principal Investigator
Facility:
Name:
H12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
34667738252
Email:
jmarti01@ucm.es
Investigator:
Last name:
Joaquin Martinez-Lopez
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Son Espases
Address:
City:
Palma
Zip:
7020
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
618830622
Email:
Albert.perez@ssib.es
Investigator:
Last name:
Albert Perez-Montana
Email:
Principal Investigator
Facility:
Name:
SUS, Lund
Address:
City:
Lund
Zip:
SE-221 85
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
46171795
Email:
goran.b.jonsson@skane.se
Investigator:
Last name:
Goran Jonson
Email:
Principal Investigator
Facility:
Name:
Uppsala UH
Address:
City:
Uppsala
Zip:
75185
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
018-6115644
Email:
Karlis.Pauksens@akademiska.se
Investigator:
Last name:
Karlis Pauksens
Email:
Principal Investigator
Facility:
Name:
Ankara University
Address:
City:
Ankara
Zip:
6620
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
903125957344
Email:
sktoprak@yahoo.com
Investigator:
Last name:
Selami Toprak
Email:
Principal Investigator
Facility:
Name:
Antalya Training and Research Hospital
Address:
City:
Antalya
Zip:
7100
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
905057656778
Email:
dr_v_karakus@yahoo.com
Investigator:
Last name:
Volkan Karakus
Email:
Principal Investigator
Facility:
Name:
Istanbul Universitesi
Address:
City:
Istanbul
Zip:
34098
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
905326818890
Email:
mcemar68@yahoo.com
Investigator:
Last name:
Muhlis Cem Ar
Email:
Principal Investigator
Facility:
Name:
Medipol Istanbul University
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
5437870708
Email:
omurgok17@hotmail.com
Investigator:
Last name:
Omur Sevindik
Email:
Principal Investigator
Start date:
October 17, 2023
Completion date:
March 1, 2026
Lead sponsor:
Agency:
Takeda
Agency class:
Industry
Source:
Takeda
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05879757
https://clinicaltrials.takeda.com/study-detail/7f0fdc7891764dc5?idFilter=%5B%22TAK-771-5006%22%5D
