Clinical trial • Phase III • Haematology

TECLISTAMAB for Relapsed/Refractory Multiple Myeloma

Phase III trial of TECLISTAMAB for Relapsed/Refractory Multiple Myeloma.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Relapsed/Refractory Multiple Myeloma
Trial Stage
Phase III
Drug Modality
Bispecific antibody|Monoclonal antibody|Small molecule|Peptide/protein/enzyme
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
30-05-2024
First CTIS Authorization Date
16-07-2024

Trial design

Randomised, daratumumab sc + pomalidomide + dexamethasone (dpd); daratumumab sc + bortezomib + dexamethasone (dvd)-controlled Phase III trial in Sweden, Poland, Germany and others.

Randomised
Yes
Comparator
Daratumumab SC + Pomalidomide + Dexamethasone (DPd); Daratumumab SC + Bortezomib + Dexamethasone (DVd)
Target Sample Size
219

Eligibility

Recruits 219 Vulnerable population selected in the trial record. Multiple subject information and informed consent form (SIS and ICF) documents are listed (e.g. Competent Adult, Withdrawal, Pregnant Partner, country-specific ICFs). Consent is obtained from participants (competent adults). No assent or parental consent procedures for minors are mentioned in the available record; participants are described as adults..

Vulnerable Population
Vulnerable population selected in the trial record. Multiple subject information and informed consent form (SIS and ICF) documents are listed (e.g. Competent Adult, Withdrawal, Pregnant Partner, country-specific ICFs). Consent is obtained from participants (competent adults). No assent or parental consent procedures for minors are mentioned in the available record; participants are described as adults.

Inclusion criteria

  • {"criterion_text":"-Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (≥) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level ≥200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio\n-Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion\n-Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen\n-Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment\n-Have clinical laboratory values within the specified range"}

Exclusion criteria

  • {"criterion_text":"-Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include: -A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG, -A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade ≥ 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization\n-Received any prior B cell maturation antigen (BCMA)-directed therapy\n-Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG\n-Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14 days before randomization\n-Received a live, attenuated vaccine within 4 weeks before randomization\n-Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-PFS","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
219
Recruitment Window Months
91
Consent Approach
Informed consent is obtained from participants (competent adults). Multiple country-specific SIS/ICF documents are provided (examples listed in the record include versions in English, Swedish, Polish, German, Dutch, French, Spanish, Danish, Greek, Italian). Documents include 'Competent Adult', 'Withdrawal', 'Pregnant Partner', and wallet card materials. No documentation of assent or parental consent for minors is present in the record.

Geography

Total Number Of Sites
73
Total Number Of Participants
310

Sweden

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
27
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Hematologkliniken
Contact Person Name
Cecilie Blimark
Contact Person Email
cecilie.blimark@vgregion.se
Site Name
Uppsala University Hospital
Department Name
KFUE- Blod- och Tumörsjukdomar
Contact Person Name
Kristina Carlson
Contact Person Email
kristina.carlson@akademiska.se
Site Name
Region Skane Helsingborg Hospital
Department Name
Hematologimottagningen
Contact Person Name
Per Axelsson
Site Name
Region Vaesterbotten
Department Name
Hematologisektionen
Contact Person Name
Antonio Izarra Santamaria
Site Name
Uppsala University Hospital
Department Name
Hematologisk dagvård
Contact Person Name
Magnus Johansson
Site Name
Region Dalarna
Department Name
Medicinkliniken Hematologimottagningen
Contact Person Name
Max Flogegård
Contact Person Email
Max.flogegard@regiondalarna.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Hematologimottagning
Contact Person Name
Markus Hansson
Contact Person Email
markus.hansson@med.lu.se
Site Name
St. Barbara-Klinik Hamm GmbH
Department Name
Hematologi/Onkologi
Contact Person Name
Heinz Dürk
Contact Person Email
hduerk@barbaraklinik.de

Poland

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
22
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz_wrobel@wp.pl
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
Oddział Hematologii i Transplantacji Szpiku
Contact Person Name
Wojciech Legiec
Contact Person Email
legiec.wojciech@gmail.com
Site Name
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Department Name
Oddzial Hematologii
Contact Person Name
Aleksandra Butrym
Contact Person Email
aleksandra.butrym@gmail.com
Site Name
Pratia Hematologia Sp. z o.o.
Contact Person Name
Sebastian Grosicki
Contact Person Email
sgrosicki@wp.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Contact Person Name
Agata Tyczynska
Contact Person Email
atyczynska@uck.gda.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworow Ukladu Chlonnego
Contact Person Name
Joanna Romejko-Jarosinska
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Hematologii i Transplantacji Szpiku
Contact Person Name
Pawel Steckiewicz
Contact Person Email
p.steckiewicz@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
19-07-2024
Processing Time Days
24
Number Of Sites
8
Number Of Participants
34

Sites

Site Name
Medical Center - University Of Freiburg
Department Name
Innere Medizin I (Hämatologie, Onkologie)
Contact Person Name
Ralph Wäsch
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik II (Myelomzentrum)
Contact Person Name
Britta Besemer
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
Contact Person Name
Song-Yau Wang
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Innere Medizin V (Hämatologie, Onkologie, Rheumatologie)
Contact Person Name
Hartmut Goldschmidt
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medizinische Klinik und Poliklinik
Contact Person Name
Katja Weisel
Contact Person Email
k.weisel@uke.de
Site Name
St. Barbara-Klinik Hamm GmbH
Department Name
Hämatologie/Onkologie
Contact Person Name
Heinz Dürk
Contact Person Email
hduerk@barbaraklinik.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Hämatologie, Onkologie und klinische Immunologie
Contact Person Name
Roland Fenk
Contact Person Email
Fenk@med.uni-duesseldorf.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medizinische Klinik und Poliklinik I, Hämatologische Ambulanz MK1-A1
Contact Person Name
Raphael Teipel

Belgium

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
19-07-2024
Processing Time Days
24
Number Of Sites
7
Number Of Participants
26

Sites

Site Name
Ziekenhuis Aan De Stroom
Department Name
Hematologie
Contact Person Name
Ka Lung Wu
Contact Person Email
kalung.wu@zna.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Hematologie
Contact Person Name
Jan Van Droogenbroeck
Contact Person Email
hematologie@azsintjan.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Hematologie
Contact Person Name
Fritz Offner
Contact Person Email
fritz.offner@uzgent.be
Site Name
CHU Helora
Department Name
Hematology
Contact Person Name
Alain Kentos
Contact Person Email
alain.kentos@jolimont.be
Site Name
UZ Leuven
Department Name
Hematologie
Contact Person Name
Michel Delforge
Contact Person Email
michel.delforge@uzleuven.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Hematologie
Contact Person Name
Alexander Salembier
Contact Person Email
hematologie@azgroeninge.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Hematologie
Contact Person Name
Lien Deleu
Contact Person Email
secr.hematologie@azdelta.be

Spain

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
19-07-2024
Processing Time Days
24
Number Of Sites
15
Number Of Participants
80

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Contact Person Name
Joaquín Martinez Lopez
Contact Person Email
jmarti01@med.ucm.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Hematology
Contact Person Name
Marta Sonia Gonzalez Perez
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Haematology and Hemotherapy
Contact Person Name
Juan Luis Reguera Ortega
Contact Person Email
juanlu_jlr@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Contact Person Name
Mercedes Gironella Mesa
Contact Person Email
merce.gironella@vallhebron.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology and Hemotherapy
Contact Person Name
Javier De La Rubia Comos
Contact Person Email
delarubia_jav@gva.es
Site Name
Hospital Universitario De Cabuenes
Department Name
Hematology
Contact Person Name
Maria Esther Gonzalez Garcia
Contact Person Email
esthergongar@yahoo.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Contact Person Name
Enrique Ocio
Contact Person Email
enriquem.ocio@unican.es
Site Name
University Hospital Son Espases
Department Name
Hematology
Contact Person Name
Antonia Sampol
Contact Person Email
antonia.sampolm@ssib.es
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Hematology
Contact Person Name
Alexia Suarez Cabrera
Contact Person Email
asuacab@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Hematology
Contact Person Name
Paula Rodriguez
Contact Person Email
paurodriguez@unav.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Haematology and Hemotherapy - Bone Marrow Transplant Unit
Contact Person Name
Cristina Encinas Rodriguez
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Haematology and Hemotherapy
Contact Person Name
Carmen Martinez-Chamorro
Site Name
Hospital Universitario De Salamanca
Department Name
Hematologia
Contact Person Name
Maria Victoria Mateos Manteca
Contact Person Email
mvmateos@usal.es
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Contact Person Name
Anna Sureda Balari
Contact Person Email
asureda@iconcologia.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Contact Person Name
Maria Jesus Blanchard Rodriguez
Contact Person Email
mjesusblanchard@yahoo.es

Denmark

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
16-07-2024
Processing Time Days
21
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Aarhus Universitetshospital
Department Name
Blodsygdomme Klinisk Forskningsenhed
Contact Person Name
Maja Oelholm
Contact Person Email
majavase@rm.dk
Site Name
Rigshospitalet
Department Name
Department of Haematology
Contact Person Name
Anne Kaersgaard Mylin
Site Name
Lillebaelt Hospital
Department Name
Department Of Hematology Section of Internal Medicine
Contact Person Name
Sarah Farmer
Contact Person Email
sarah.farmer1@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Department of Haematology
Contact Person Name
Henrik Gregersen
Contact Person Email
henrik.gregersen@rn.dk
Site Name
Odense University Hospital
Department Name
Haematologisk Forskningsenhed HFE-X
Contact Person Name
Charlotte Toftmann Hansen

Netherlands

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
16-07-2024
Processing Time Days
21
Number Of Sites
5
Number Of Participants
23

Sites

Site Name
Stichting Radboud universitair medisch centrum
Department Name
Hematologie
Contact Person Name
Elizabeth de Kort
Contact Person Email
Elizabeth.deKort@radboudumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematologie
Contact Person Name
Wouter Plattel
Contact Person Email
w.j.plattel@umcg.nl
Site Name
Stichting Amsterdam UMC
Department Name
Hematologie
Contact Person Name
Niels van de Donk
Contact Person Email
hematology@amsterdamumc.nl
Site Name
St. Antonius Ziekenhuis
Department Name
Hematologie
Contact Person Name
Elena van Leeuwen
Site Name
Isala Klinieken Stichting
Department Name
Hematolgoie
Contact Person Name
Paul Geerts
Contact Person Email
p.a.f.geerts@isala.nl

Greece

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
18-09-2024
Processing Time Days
23
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Alexandra Hospital
Department Name
Therapeutic Clinic-Oncology Department of, General Hospital of Athens
Contact Person Name
Athanasios - Meletios Dimopoulos
Contact Person Email
mdimop@med.uoa.gr
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Hematology Department - Bone Marrow Transplantation Unit
Contact Person Name
Michail Iskas
Contact Person Email
michail.iskas@gpapanikolaou.gr
Site Name
Theageneio Cancer Hospital
Department Name
Hematology Department
Contact Person Name
Eirini Kotodritou
Contact Person Email
eirinikatodritou@gmail.com

France

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
27
Number Of Sites
10
Number Of Participants
37

Sites

Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hematology Department
Contact Person Name
Stéphane MOREAU
Contact Person Email
stephane.moreau@chu-limoges.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hematology Department
Contact Person Name
Thomas CHALOPIN
Contact Person Email
t.chalopin@chu-tours.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Hematology Department
Contact Person Name
Cecile SONNTAG
Contact Person Email
c.sonntag@icans.eu
Site Name
Hospices Civils De Lyon
Department Name
Hematology Department
Contact Person Name
Lionel KARLIN
Contact Person Email
lionel.karlin@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hematology Department
Contact Person Name
Aurore PERROT
Contact Person Email
perrot.aurore@iuct-oncopole.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematology Department
Contact Person Name
Xavier LELEU
Contact Person Email
xavier.leleu@chu-poitiers.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Oncology and Hematology
Contact Person Name
Cecile SONNTAG
Contact Person Email
c.sonntag@icans.eu
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology Department
Contact Person Name
Philippe MOREAU
Contact Person Email
philippe.moreau@chu-nantes.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology Department
Contact Person Name
Karim BELHADJ
Contact Person Email
karim.belhadj@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Blood Diseases Department
Contact Person Name
Salomon MANIER
Contact Person Email
salomon.manier@chru-lille.fr

Italy

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
27
Number Of Sites
5
Number Of Participants
30

Sites

Site Name
University Hospital Consorziale Policlinico
Department Name
U.O. Ematologia con Trapianto
Contact Person Name
Pellegrino Musto
Contact Person Email
pellegrino.musto@uniba.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Oncologia
Contact Person Name
Francesca Gay
Contact Person Email
francesca.gay@unito.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Department Name
SC Ematologia
Contact Person Name
Monica Galli
Contact Person Email
monicagalli@asst-pg23.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UOC Ematologia
Contact Person Name
Elena Zamagni
Contact Person Email
e.zamagni@unibo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia
Contact Person Name
Claudio Cerchione
Contact Person Email
claudio.cerchione@irst.emr.it

Sponsor

Primary sponsor

Full Name
Janssen - Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Medidata Solutions Inc.
Responsibilities
sponsorDuties codes: 7
Name
Almac Clinical Services LLC
Responsibilities
sponsorDuties codes: 3
Name
IQVIA RDS & Integrated Services Belgium
Responsibilities
sponsorDuties codes: 1, 12

Third parties

  • {"country":"Malaysia","full_name":"Hematogenix","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCOA / ePRO data collection","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Hematogenix Laboratory Services Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"IQVIA RDS & Integrated Services Belgium","duties_or_roles":"sponsorDuties codes: 1, 12","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
teclistamab
Active Substance
TECLISTAMAB
Modality
Bispecific antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
Not authorised/No marketing authorisation (prodAuthStatus: 1)
Investigational Product Name
DARZALEX 1800 mg solution for injection
Active Substance
DARATUMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
Authorised (prodAuthStatus: 2)
Orphan Designation
Yes
Investigational Product Name
Pomalidomide / Imnovid (various strengths)
Active Substance
POMALIDOMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised (prodAuthStatus: 2) for marketed Imnovid presentations; some sponsor-specific product entries show prodAuthStatus: 1
Orphan Designation
Yes
Investigational Product Name
Dexamethasone (various tablet products listed)
Active Substance
DEXAMETHASONE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised (prodAuthStatus: 2) for listed marketed presentations
Investigational Product Name
VELCADE 3.5 mg powder for solution for injection
Active Substance
BORTEZOMIB
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
Authorised (prodAuthStatus: 2)
Investigational Product Name
Privigen 100 mg/ml solution for infusion
Active Substance
HUMAN NORMAL IMMUNOGLOBULIN
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
Authorised (prodAuthStatus: 2)
Combination Treatment
Yes

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