Clinical trial • Phase III • Oncology|Haematology|Immunology

HUMAN NORMAL IMMUNOGLOBULIN for Multiple myeloma | Secondary immunodeficiency

Phase III trial of HUMAN NORMAL IMMUNOGLOBULIN for Multiple myeloma | Secondary immunodeficiency.

Overview

Trial Therapeutic Area
Oncology|Haematology|Immunology
Trial Disease
Multiple myeloma | Secondary immunodeficiency
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme|Bispecific antibody

Key dates

Initial CTIS Submission Date
30-04-2025
First CTIS Authorization Date
25-08-2025

Trial design

Randomised, open-label, treatment arm 1: intravenous gammagard liquid (kiovig 100 mg/ml solution for infusion) for primary infection prophylaxis (iv infusion; dose unit mg/kg per protocol). treatment arm 2: secondary infection prophylaxis (control arm) — described as control arm; no specific imp dose or schedule stated for the control in the available record., adaptive Phase III trial in Spain, Austria, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Treatment Arm 1: Intravenous Gammagard Liquid (KIOVIG 100 mg/ml solution for infusion) for primary infection prophylaxis (IV infusion; dose unit mg/kg per protocol). Treatment Arm 2: Secondary infection prophylaxis (control arm) — described as control arm; no specific IMP dose or schedule stated for the control in the available record.
Adaptive
True, group-sequential (group-sequential design is specified in the study title indicating planned interim analyses).
Target Sample Size
212
Trial Duration For Participant
365

Eligibility

Recruits 212 Vulnerable population selected. Informed consent must be provided in writing via a signed and dated ICF before initiation of any study procedures (Inclusion criterion: "The subject has provided informed consent (ie, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any study procedures."). Participants must be at least 18 years of age (no paediatric/assent procedures described). Specific participant information/ICF documents for pregnant participants and optional PK‑PD/other optional consent modules are included among study documents..

Pregnancy Exclusion
29. The subject is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.
Vulnerable Population
Vulnerable population selected. Informed consent must be provided in writing via a signed and dated ICF before initiation of any study procedures (Inclusion criterion: "The subject has provided informed consent (ie, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any study procedures."). Participants must be at least 18 years of age (no paediatric/assent procedures described). Specific participant information/ICF documents for pregnant participants and optional PK‑PD/other optional consent modules are included among study documents.

Inclusion criteria

  • {"criterion_text":"- 1. The subject must have a documented diagnosis of MM according to the guidelines by the IMWG before enrollment.\n- 2. Subjects who recently started teclistamab within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months.\n- 3. The subject has provided informed consent (ie, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any study procedures.\n- 4. The subject is at least 18 years of age at the time of signing the ICF.\n- 5. If a person of childbearing potential engages in sexual relations that carry risk of pregnancy, they agree to the following for the period from screening until 30 days after the last dose of study drug: •\tTo use a highly effective contraceptive method. •\tTo avoid donating ova."}

Exclusion criteria

  • {"criterion_text":"- 1. The subject has not achieved at least a minimal response to teclistamab within 8 weeks during the screening period.\n- 10. The subject is scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening.\n- 11. The subject may be excluded from the study if, in the opinion of the investigator, the subject is at high risk for symptomatic hyperviscosity syndrome.\n- 12. The subject has major surgery scheduled during the study, or the subject has not fully recovered from a recent major surgery (as judged by the investigator) during screening (subjects with planned surgical procedures to be conducted under local anesthesia may participate).\n- 13. The subject has an active secondary (non-MM) malignancy or other medical condition with life‑expectancy of <2 years.\n- 14. The subject has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) after IVIG and/or immune serum globulin infusions.\n- 15. The subject has a known history or current diagnosis of thromboembolic episodes such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease within 6 months before screening.\n- 16. The subject has moderate to severe renal dysfunction based on an estimated glomerular filtration rate ≤30 mL/min/1.73 m2, as defined by Kidney Disease: Improving Global Outcomes Clinical Practice Guideline for the Management of Glomerular Diseases, 2021 at the time of screening.\n- 17. The subject has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen, PCR for hepatitis C virus, PCR for HIV Type 1 and Type 2. Cured subjects with a history of hepatitis C infection who have a negative PCR test at screening are eligible.\n- 18. The subject has a documented diagnosis of a form of PID involving a defect in antibody formation and requiring IgG replacement, as defined according to the International Union of Immunological Societies Committee.\n- 19. The subject has a persistent serum aspartate aminotransferase and alanine aminotransferase >3.0 times the upper limit of normal at screening (may be repeated once to determine if it is persistent).\n- 2. The subject has a current serious infection or >1 serious infection in the past 3 months before screening.\n- 20. The subject has an immunoglobulin A (IgA) deficiency (<0.07 g/L) with antibodies to IgA and a history of hypersensitivity reaction to IVIG.\n- 21. Subjects with a known systemic hypersensitivity to any of the excipients of IGI, 10% in accordance with the investigator’s brochure/package insert/Summary of Product Characteristics.\n- 22. Known substance abuse including opiates, psychostimulant agents, or other illicit drugs with the exception of cannabinoids within 12 months of screening.\n- 23. The subject has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator (may be repeated once to determine if it has resolved).\n- 24. The subject has a medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with the successful completion of the study or place the subject at undue medical risk.\n- 25. The subject is receiving immunosuppressive treatment (other than for MM or corticosteroids) at screening or plans to receive immunosuppressive treatment after study enrollment.\n- 26. The subject is not willing and able to comply with the protocol requirements.\n- 27. The subject has participated or is scheduled to participate in another clinical study involving an IP or investigational device within 30 days before screening and during the course of the study.\n- 28. The subject is a family member or employee of the investigator or the investigator’s site staff.\n- 29. The subject is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.\n- 3. The subject has a documented polyclonal IgG level <150 mg/dL at the most recent assessment before teclistamab initiation (within 4 weeks) as assessed by the investigator according to the site’s standard practice.\n- 4. The subject is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.\n- 5. The subject has received a hyperimmune or specialty high-titer immunoglobulin product (eg, cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin) within 30 days before screening.\n- 6. The subject has received live viral vaccines within 30 days before screening.\n- 7. The subject has an Eastern Cooperative Oncology Group performance status score of >2.\n- 8. The subject has an active viral or bacterial infection or symptoms/signs of such an infection requiring treatment with anti-infectives within 1 week before enrollment.\n- 9. The subject has received other BCMA×CD3–directed BsAb therapy any time before screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time to the first serious infection.","definition_or_measurement_approach":"Time-to-event endpoint measured as time from randomization/enrolment to first serious infection during follow-up; observational period referenced elsewhere as 12 months."}

Secondary endpoints

  • {"endpoint_text":"- 1. Occurrence of at least 1 serious infection during the observational period of 12 months.","definition_or_measurement_approach":"Binary occurrence measured during the 12-month observational/follow-up period."}
  • {"endpoint_text":"- 2. Annualized rate of days on antibiotics (for treatment of bacterial infections).","definition_or_measurement_approach":"Annualized count of days subjects receive antibiotics for bacterial infections (rate per year)."}
  • {"endpoint_text":"- 3. Annualized rate of bacterial infections.","definition_or_measurement_approach":"Annualized incidence rate of bacterial infections per subject (rate per year)."}

Recruitment

Digital Remote Recruitment
True — digital/remote methods explicitly documented include country-specific websites with online screener scripts, banner ads, video scripts, email communications (including 'Advocacy Email'), online patient brochures and digital mailers (Reloadable ScoutPass materials).
Planned Sample Size
172
Recruitment Window Months
37
Consent Approach
Consent is obtained from the subject (adult participants) in writing via a signed and dated informed consent form (ICF) prior to any study procedures. Study documents include multiple ICF variants (main ICF, pregnancy-specific ICF, optional PK‑PD ICF, privacy/GDPR forms) and translated/plain-language materials. Available consent/information documents cover multiple languages (examples in the document list: English, Spanish, Dutch, Greek, Hungarian, Polish, German, Italian, Czech, French, Romanian, Norwegian). Participants must be ≥18 years so assent procedures for minors are not described.

Methods

  • Website (country-specific website materials and online screener script) — documents include K2_Website and Website screener script.
  • HCP outreach: HCP letters and HCP flyers (materials to engage treating physicians and healthcare professionals).
  • Patient-targeted materials: Patient brochures, patient recruitment flyers, Dear Patient letters.
  • Digital advertising: Banner ads, video content (video scripts) and online banner campaigns.
  • Email communications: Advocacy emails and direct email communications to potential participants / HCPs.
  • Platform/third‑party recruitment: Scout Clinical / ScoutPass related materials (reloadable ScoutPass brochure and mailer) and other vendor-facilitated recruitment materials.
  • Country-specific recruitment materials: Localised materials and procedures are prepared (examples in Romanian, Norwegian and other country-specific folders) and K1 recruitment/process documents per country.

Geography

Total Number Of Sites
46
Total Number Of Participants
172

Spain

Earliest CTIS Part Ii Submission Date
07-07-2025
Latest Decision Or Authorization Date
02-01-2026
Processing Time Days
179
Number Of Sites
8
Number Of Participants
35

Sites

Site Name
Hospital Universitario De Salamanca
Department Name
Hematology service
Contact Person Name
Maria Victoria Mateos Manteca
Contact Person Email
mvmateos@usal.es
Site Name
University Hospital Son Espases
Department Name
Hematology service
Contact Person Name
Albert Perez -Montana
Contact Person Email
albert.perez@ssib.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology service
Contact Person Name
Joaquin Martinez Lopez
Contact Person Email
jmarti01@ucm.es
Site Name
Hospital Clinico San Carlos
Department Name
Hematology service
Contact Person Name
Eduardo Anguita Mandly
Contact Person Email
eanguita@ucm.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology service
Contact Person Name
Francisco Javier de la Rubia Comos
Contact Person Email
delarubia_jav@gva.es
Site Name
Hospital Universitario La Paz
Department Name
Hematology service
Contact Person Name
Ana Lopez de la Guia
Contact Person Email
aldelaguia@salud.madrid.org
Site Name
Hospital Costa Del Sol
Department Name
Hematology service
Contact Person Name
Maria Casanova Espinosa
Contact Person Email
mariacasanova@yahoo.com
Site Name
Hospital Universitario La Paz (duplicate entry in list?)
Department Name
Hematology service
Contact Person Name
Maria Casanova Espinosa
Contact Person Email
mariacasanova@yahoo.com

Austria

Earliest CTIS Part Ii Submission Date
11-08-2025
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
154
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Elisabethinen I. Internal Depart., Hematology w. stem cell transpl., haemostaseology & med. oncology
Contact Person Name
Irene Strassl
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
University Hospital St. Pölten Department of Internal Medicine 1.
Contact Person Name
Petra Pichler-Izmir
Site Name
Krankenhaus Der Barmherzigen Schwestern Wien Betriebsgesellschaft mbH
Department Name
I. Medizinischen Abteilung - Onkologie & Hämatologie
Contact Person Name
Eva-Maria Autzinger
Contact Person Email
evamaria.autzinger@bhs.at

Czechia

Earliest CTIS Part Ii Submission Date
29-07-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
163
Number Of Sites
3
Number Of Participants
27

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie
Contact Person Name
Roman Hájek
Contact Person Email
roman.hajek@fno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. interní klinika – klinika hematologie
Contact Person Name
Jan Straub
Contact Person Email
jan.straub@vfn.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. interní hematologická klinika
Contact Person Name
Jakub Radocha
Contact Person Email
radochaj@lfhk.cuni.cz

Germany

Earliest CTIS Part Ii Submission Date
13-08-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
163
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
University Hospital Cologne AöR
Department Name
Universitätsklinikum Köln AöR Innere Medizin und Hämatologie und Onclogie
Contact Person Name
Tim Richardson
Contact Person Email
tim.richardson@uk-koeln.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Asklepios Klinik Altona Hämatologie
Contact Person Name
Hans-Jürgen Salwender
Contact Person Email
h.salwender@asklepios.com
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Hämatologie und Stammzelltransplantation
Contact Person Name
Amelie Boquoi
Contact Person Email
amelie.boquoi@uk-essen.de

Netherlands

Earliest CTIS Part Ii Submission Date
25-07-2025
Latest Decision Or Authorization Date
24-12-2025
Processing Time Days
152
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Hematology
Contact Person Name
N Van Donk
Contact Person Email
hematology@amsterdamumc.nl
Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Internal Medicine/Hematology
Contact Person Name
I.S. Nijhof

Denmark

Earliest CTIS Part Ii Submission Date
29-07-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
163
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Odense University Hospital
Department Name
Department of Hematology
Contact Person Name
Ida Bruun Kristensen
Contact Person Email
Ida.Bruun.Kristensen@rsyd.dk
Site Name
Region Midtjylland
Department Name
Department of Hematology
Contact Person Name
Maja Ølholm Vase
Contact Person Email
majavase@rm.dk
Site Name
Aalborg University Hospital
Department Name
Department of Hematology
Contact Person Name
Henrik Gregersen
Contact Person Email
Henrik.gregersen@rn.dk
Site Name
Rigshospitalet
Department Name
Department of Hematology
Contact Person Name
Agoston Gyula Szabo
Contact Person Email
agoston.gyula.szabo@regionh.dk

Hungary

Earliest CTIS Part Ii Submission Date
03-07-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
189
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Department Name
Haematológiai és Haemosztazeológiai Osztály
Contact Person Name
Márk Plander
Contact Person Email
plander.mark@markusovszky.hu
Site Name
University Of Debrecen
Department Name
Klinikai Központ, Belgyógyászati Klinika
Contact Person Name
Árpád Illés
Contact Person Email
Illes.arpad@med.unideb.hu
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Hematológiai Osztály
Contact Person Name
Péter Rajnics
Contact Person Email
rajnics.peter@kmmk.hu

Poland

Earliest CTIS Part Ii Submission Date
29-07-2025
Latest Decision Or Authorization Date
04-01-2026
Processing Time Days
159
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Aidport Sp. z o.o.
Contact Person Name
Michał Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Contact Person Name
Agata Tyczyńska
Contact Person Email
atyczynska@uck.gda.pl

Italy

Earliest CTIS Part Ii Submission Date
25-07-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
151
Number Of Sites
7
Number Of Participants
18

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
SOD Clinica Ematologica
Contact Person Name
Massimo Offidani
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UOC Ematologia Via Benevento 6 - 00161 Roma, Italy
Contact Person Name
Maria Teresa Petrucci
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
U.O. Ematologia con Trapianto di Midollo Osseo
Contact Person Name
Francesco Di Raimondo
Contact Person Email
Francesco.diraimondo@unict.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
SC Ematologia
Contact Person Name
Paolo Corradini
Contact Person Email
paolo.corradini@unimi.it
Site Name
Azienda Sanitaria Locale Di Pescara
Department Name
PO Santo Spirito - UO Ematologia Clinica, Via Fonte Romana 8, Pescara 65124 Italy
Contact Person Name
Carmine Liberatore
Contact Person Email
carmine.liberatore@asl.pe.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Ematologia I
Contact Person Name
Silvia Mangiacavalli
Contact Person Email
s.mangicavalli@sanmatteo.pv.it
Site Name
Other listed Italian site

Greece

Earliest CTIS Part Ii Submission Date
21-05-2025
Latest Decision Or Authorization Date
24-12-2025
Processing Time Days
217
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
University General Hospital Of Ioannina
Department Name
Hematology Clinic
Contact Person Name
Eleftheria Hatzimichael
Contact Person Email
haematology@uhi.gr
Site Name
Alexandra Hospital
Department Name
Therapeutic Clinic of National & Kapodistrian University of Athens
Contact Person Name
Meletios-Athanasios Dimopoulos

Romania

Earliest CTIS Part Ii Submission Date
09-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
21
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Institutul Clinic Fundeni
Department Name
Sectia Ia
Contact Person Name
Sorina Nicoleta Badelita
Contact Person Email
sorinabadelita@gmail.com
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
Hematology
Contact Person Name
Mihaela Andreescu
Contact Person Email
tevetmihaela@gmail.com
Site Name
Spitalul Clinic Municipal Filantropia Craiova
Department Name
Hematology
Contact Person Name
Ocroteala Luminita
Contact Person Email
diaconu_luminita@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Hematology
Contact Person Name
Cirpian Ionut Tomuleasa
Contact Person Email
iprian.tomuleasa@gmail.com
Site Name
Spitalul Clinic Coltea
Department Name
Hematology
Contact Person Name
Gabriela Borsaru
Contact Person Email
gabriex2001@yahoo.it

Norway

Earliest CTIS Part Ii Submission Date
30-04-2026
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
6
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Oslo Universitetssykehus HF
Department Name
Oslo Universitetssykehus Rikshospitalet
Contact Person Name
Fredrik Schjesvold
Contact Person Email
fredrikschjesvold@gmail.com
Site Name
Helse Nord-Trondelag HF
Department Name
Helse Nord-Troendelag Thrust
Contact Person Name
Vidar Vidar Stavseth
Site Name
St. Olavs Hospital HF
Department Name
S.t Olavs Hospital
Contact Person Name
Tobias Slørdahl
Contact Person Email
tobias.s.slordahl@ntnu.no
Site Name
Akershus University Hospital
Department Name
Akershus University Hospital
Contact Person Name
Anette Eilertsen Løken
Contact Person Email
anette.loken.eilertsen@ahus.no

Sponsor

Primary sponsor

Full Name
Takeda Development Center Americas Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
CRO
Name
PRA Hellas CRO A.E.
Responsibilities
Study start up, contract negotiation and monitoring activities in Greece

Third parties

  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursements","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"AG Mednet Inc.","duties_or_roles":"Adjudication processes","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Patient materials","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"Study start up, contract negotiation and monitoring activities in Greece","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
KIOVIG 100 mg/ml solution for infusion
Active Substance
HUMAN NORMAL IMMUNOGLOBULIN
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Dose Levels
100 mg/ml; dosing unit specified as mg/kg in product record
Maximum Dose
17000 mg/kg
Investigational Product Name
TECVAYLI 10 mg/mL solution for injection
Active Substance
TECLISTAMAB
Modality
Bispecific antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Starting Dose
10 mg/mL (step-up)
Dose Levels
10 mg/mL (step-up)
Investigational Product Name
TECVAYLI 90 mg/mL solution for injection
Active Substance
TECLISTAMAB
Modality
Bispecific antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Starting Dose
90 mg/mL (maintenance)
Dose Levels
90 mg/mL (maintenance)
Combination Treatment
Yes

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