Clinical trial • Phase III • Oncology

ISATUXIMAB for Relapsed and/or refractory multiple myeloma | Recurrent plasma cell myeloma

Phase III trial of ISATUXIMAB for Relapsed and/or refractory multiple myeloma | Recurrent plasma cell myeloma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed and/or refractory multiple myeloma | Recurrent plasma cell myeloma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
12-04-2024
First CTIS Authorization Date
14-05-2024

Trial design

Randomised, open-label, two active comparator regimens: isatuximab administered subcutaneously (sc) in combination with pomalidomide and dexamethasone versus isatuximab administered intravenously (iv) in combination with pomalidomide and dexamethasone. documented product dose references in metadata: isatuximab (iv formulation) listed with dose metric up to 10 mg/kg; isatuximab (sc formulation) listed with a max dose metric 1400 mg in product metadata; pomalidomide oral capsules listed with daily dose metric up to 4 mg; dexamethasone oral tablets listed (various strengths). exact study dosing schedule not provided in the metadata.-controlled Phase III trial in Czechia, Greece, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Two active comparator regimens: isatuximab administered subcutaneously (SC) in combination with pomalidomide and dexamethasone versus isatuximab administered intravenously (IV) in combination with pomalidomide and dexamethasone. Documented product dose references in metadata: Isatuximab (IV formulation) listed with dose metric up to 10 mg/kg; Isatuximab (SC formulation) listed with a max dose metric 1400 mg in product metadata; pomalidomide oral capsules listed with daily dose metric up to 4 mg; dexamethasone oral tablets listed (various strengths). Exact study dosing schedule not provided in the metadata.
Target Sample Size
389

Eligibility

Recruits 389 The trial record flags a vulnerable population selection (isVulnerablePopulationSelected = true). Informed consent is managed via subject information and informed consent form (ICF) documents (multiple ICF documents and addenda are listed). No specific assent procedures or detailed vulnerable-group consent handling text is provided in the available metadata..

Pregnancy Exclusion
-Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control
Vulnerable Population
The trial record flags a vulnerable population selection (isVulnerablePopulationSelected = true). Informed consent is managed via subject information and informed consent form (ICF) documents (multiple ICF documents and addenda are listed). No specific assent procedures or detailed vulnerable-group consent handling text is provided in the available metadata.

Inclusion criteria

  • {"criterion_text":"-Participants with multiple myeloma who have received at least one prior line of anti- myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.\n-Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65))."}

Exclusion criteria

  • {"criterion_text":"-Primary refractory multiple myeloma participants\n-Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.\n-Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control\n-Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received\n-Prior therapy with pomalidomide\n-Participants with inadequate biological tests.\n-Significant cardiac dysfunction\n- Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy\n-Concomitant plasma cell leukemia\n-Active primary amyloid light -chain amyloidosis\n-Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Overall response rate (ORR)\n-Observed concentration before dosing (Cthrough) at steady state","definition_or_measurement_approach":"Overall response rate (ORR): listed as primary endpoint (no further definition provided in metadata). Observed concentration before dosing (Ctrough) at steady state: listed as primary PK endpoint (no further method details available in metadata)."}

Secondary endpoints

  • {"endpoint_text":"-Very Good Partial Response or better rate (VGPR\n-Observed concentration before dosing (Ctrough)\n-Incidence rate of infusion-reactions\n-Percentage of participants satisfied or very satisfied with the injection method used to administer study medication\n-Duration of response (DOR)\n-Time to first response (TT1R)\n-Time to best response (TTBR)\n-Progression free survival (PFS)\n-Overall survival (OS)\n-Progression free survival 2 (PFS2)\n-Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs)\n-Pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax)\n-PK parameter: Area under the plasma concentration time curve over the dosing period (AUC)\n-Successful injection rate\n-Percentage of participants with anti-drug antibodies (ADA) against isatuximab\n-Participant expectation questionnaire-baseline (PEQ-BL) score\n-Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score\n-Patient experience and satisfaction questionnaire-end of treatment (PESQ-EOT) score\n-Patient’s Assessment of Treatment (PAT) questionnaire score\n-Change from baseline in the Health Resource Utilization and Productivity Questionnaire (HRUPQ) scores\n-Change from baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score\n-Change from baseline in European Organization for Research and Treatment of Cancer quality of life myeloma module (EORTC QLQ-MY20)\n-Change from baseline in the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) scores\n-Number of participants with chromosomal abnormalities","definition_or_measurement_approach":"Secondary endpoints are listed in the protocol metadata. Detailed definitions, timepoints and specific measurement methods are not provided in the available metadata."}

Recruitment

Planned Sample Size
389
Recruitment Window Months
56
Consent Approach
Informed consent is obtained using subject information and informed consent form documents. Multiple ICF documents and site-specific addenda are listed in the metadata (examples: L1-sis-icf-main in EN and site/language-specific versions). There are partner-pregnancy and device-specific ICF addenda listed. ICF language availability (based on provided documents) includes English, Greek, French, Polish, Spanish, German, Italian, Swedish, Hungarian, Norwegian, Czech (multiple language-specific ICFs are present). The metadata does not provide detailed text of assent processes for minors (trial is specified for adult patients).

Geography

Total Number Of Sites
57
Total Number Of Participants
389

Czechia

Earliest CTIS Part Ii Submission Date
25-04-2024
Latest Decision Or Authorization Date
20-05-2024
Processing Time Days
25
Number Of Sites
4
Number Of Participants
44

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie
Contact Person Name
Roman Hajek
Contact Person Email
roman.hajek@fno.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interni hematologicka a onkologicka klinika FN Brno a LF MU
Contact Person Name
Ludek Pour
Contact Person Email
pour.ludek@fnbrno.cz
Site Name
University Hospital Olomouc
Department Name
Onkologicka klinika
Contact Person Name
Jiri Minarik
Contact Person Email
abretina@email.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. interni klinika
Contact Person Name
Ivan Spicka
Contact Person Email
spicka@cesnet.cz

Greece

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
30-07-2024
Processing Time Days
29
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
General University Hospital Of Patras
Department Name
Hematology clinic-Bone Marrow Transplantation Unit
Contact Person Name
Alexandros Spyridonidis
Contact Person Email
spyridonidis@upatras.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Hemmatology clinic
Contact Person Name
Michael Iskas
Contact Person Email
mic_iskas@yahoo.fr
Site Name
Alexandra Hospital
Department Name
Hematology- Oncology Section, Dept of Clinical Therapeutics
Contact Person Name
Meletios-Athanasios Dimopoulos
Contact Person Email
mdimop@med.uoa.gr
Site Name
Evaggelismos Hospital
Department Name
Hematology clinic
Contact Person Name
Sosana Delimpasi
Contact Person Email
sodeli@yahoo.com
Site Name
University General Hospital Of Ioannina
Department Name
Hematology clinic
Contact Person Name
Eleni Kapsali
Contact Person Email
elkapsali@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
25-04-2024
Latest Decision Or Authorization Date
14-05-2024
Processing Time Days
19
Number Of Sites
8
Number Of Participants
35

Sites

Site Name
Institut Catala D'oncologia
Department Name
Institut Català d'Oncologia - Institut de Recerca Josep Carreras
Contact Person Name
Albert Oriol
Contact Person Email
aoriol@iconcologia.net
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Servicio de Hematologia
Contact Person Name
Enrique Ocio
Contact Person Email
ocioem@unican.es
Site Name
Hospital Universitario De Salamanca
Department Name
Servicio de Hematologia
Contact Person Name
Victoria Mateos
Contact Person Email
mvmateos@usal.es
Site Name
Hospital Universitario La Paz
Department Name
Servicio de Hematologia
Contact Person Name
Ana Lopez de la Guia
Contact Person Email
aldelaguia@salud.madrid.org
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
UTMO (Unidad de trasplante de médula osea)
Contact Person Name
Maria Jesus Blanchard Rodriguez
Site Name
Clinica Universidad De Navarra
Department Name
Servicio de Hematologia
Contact Person Name
Paula Rodriguez Otero
Contact Person Email
paurodriguez@unav.es
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Servicio de Hematologia
Contact Person Name
Valentin Cabanas Perianes
Contact Person Email
valentin.cabanas@gmail.com
Site Name
Hospital Universitario La Paz (additional listed site)
Department Name
Servicio de Hematologia
Contact Person Name
Ana Lopez de la Guia
Contact Person Email
aldelaguia@salud.madrid.org

Poland

Earliest CTIS Part Ii Submission Date
25-04-2024
Latest Decision Or Authorization Date
24-05-2024
Processing Time Days
29
Number Of Sites
4
Number Of Participants
23

Sites

Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz.wrobel@umed.wroc.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Hematologii i Chorób Wewnętrznych
Contact Person Name
Artur Jurczyszyn
Contact Person Email
mmjurczy@cyf-kr.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Klinika Hematoonkologii i Transplantacji Szpiku
Contact Person Name
Marek Hus
Contact Person Email
marek.hus@umlub.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddzial Hematologiczny
Contact Person Name
Jaroslaw Dybko
Contact Person Email
jaroslaw.dybko@dcopih.pl

Hungary

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
16-05-2024
Processing Time Days
1
Number Of Sites
9
Number Of Participants
25

Sites

Site Name
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Department Name
Haematologiai és Haemosztazeologiai Osztaly
Contact Person Name
Mark Plander
Contact Person Email
plander.mark@markusovszky.hu
Site Name
Semmelweis University
Department Name
Belgyogyaszati es Hematologiai Klinika
Contact Person Name
Zsolt Nagy
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
Belgyogyaszat - III. Belgyogyaszat, Hematologiai Osztaly
Contact Person Name
Arpad Batai
Contact Person Email
labatai@mail.fmkorhaz.hu
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Haematologiai Osztaly
Contact Person Name
Peter Rajnics
Contact Person Email
rajnicsp@hotmail.com
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz (additional listed site)
Department Name
Belgyogyaszat - III. Belgyogyaszat, Hematologiai Osztaly
Contact Person Name
Mária Dömötör
Contact Person Email
mariadomotor@gmail.com
Site Name
University Of Pecs
Department Name
I. sz. Belgyógyászati Klinika
Contact Person Name
Szabolcs Kosztolanyi
Contact Person Email
kosztolanyi.szabolcs@pte.hu
Site Name
University Of Pecs (additional listed site)
Department Name
I.sz. Belgyogyaszati Klinika, Hematologiai Tanszek
Contact Person Name
Szabolcs Kosztolanyi
Contact Person Email
kosztolanyi.szabolcs@pte.hu
Site Name
Semmelweis University (additional listed site)
Department Name
Belgyogyaszati es Haematologiai Klinika
Contact Person Name
Zsolt Nagy
Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
Hematologiai es Ossejt-transzplantacios Osztaly
Contact Person Name
Gabor Mikala
Contact Person Email
gmikala@dpckorhaz.hu

Germany

Earliest CTIS Part Ii Submission Date
25-04-2024
Latest Decision Or Authorization Date
15-05-2024
Processing Time Days
20
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Hamatologie/Onkologie
Contact Person Name
Niklas Gebauer
Contact Person Email
niklas.gebauer@uksh.de
Site Name
Klinikum Nuernberg
Department Name
Hamatologie/Onkologie
Contact Person Name
Stefan Knop
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Innere Medizin V
Contact Person Name
Hartmut Goldschmidt

France

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
30-05-2024
Processing Time Days
8
Number Of Sites
9
Number Of Participants
17

Sites

Site Name
Centre Leon Berard
Department Name
Hématologie Cancérologie Médicale
Contact Person Name
Philippe Rey
Contact Person Email
philippe.rey@lyon.unicancer.fr
Site Name
Hospices Civils De Lyon
Department Name
Service Hematologie Clinique
Contact Person Name
Lionel Karlin
Contact Person Email
lionel.karlin@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Oncologie Médicale
Contact Person Name
Xavier Leleu
Contact Person Email
xavier.leleu@chu-poitiers.fr
Site Name
Centre Hospitalier De Perigueux
Department Name
Service Oncologie-Hématologie
Contact Person Name
Claire CALMETTES
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service d'hématologie et thérapie cellulaire
Contact Person Name
Aurore Perrot
Contact Person Email
perrot.aurore@iuct-oncopole.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Département d'Hématologie et Thérapie Cellulaire
Contact Person Name
Emilie Chalayer
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'hématologie et thérapie cellulaire
Contact Person Name
Mohamad Mohty
Contact Person Email
mohamad.mohty@inserm.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d'Hematologie
Contact Person Name
Philippe Moreau
Contact Person Email
philippe.moreau@chu-nantes.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hématologie Cancérologie Médicale
Contact Person Name
Thomas Chalopin
Contact Person Email
t.chalopin@chu-tours.fr

Italy

Earliest CTIS Part Ii Submission Date
25-04-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
39
Number Of Sites
9
Number Of Participants
15

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
U.O.C Ematologia
Contact Person Name
Michele Cavo
Contact Person Email
michele.cavo@unibo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
U.O. Ematologia
Contact Person Name
Claudio Cerchione
Contact Person Email
claudio.cerchione@irst.emr.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
U.O.C Ematologia
Contact Person Name
Fabrizio Pane
Contact Person Email
fabrizio.pane@unina.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
U.O. Ematologia
Contact Person Name
Silvia Mangiacavalli
Contact Person Email
s.mangiacavalli@smatteo.pv.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Unità Operativa Complessa Servizio e DH di Ematologia
Contact Person Name
Valerio De Stefano
Contact Person Email
valerio.destefano@unicatt.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O. Ematologia
Contact Person Name
Alessandra Tucci
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
SOD Clinica Ematologica
Contact Person Name
Massimo Offidani
Site Name
Azienda Ospedaliero-Universitaria Di Bologna (additional listed site)
Department Name
U.O.C Ematologia
Contact Person Name
Elena Zamagni
Contact Person Email
e.zamagni@unibo.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Operativa Complessa di Ematologia
Contact Person Name
Cirino Botta
Contact Person Email
cirino.botta@gmail.com

Norway

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
14-05-2024
Processing Time Days
8
Number Of Sites
2
Number Of Participants
14

Sites

Site Name
Oslo University Hospital HF
Department Name
Poliklinikk, Blodsykdommer bygn 20
Contact Person Name
Fredrik Schjesvold
Contact Person Email
fredrikschjesvold@gmail.com
Site Name
Helse Moere Og Romsdal HF
Department Name
Department of Clinical and Molecular Medicine Department of Health Sciences Ålesund
Contact Person Name
Eivind Samstad

Sweden

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
20
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
Karolinska University Hospital
Department Name
Hematologi Mottagning
Contact Person Name
Johan Lund
Site Name
Sodra Alvsborg Hospital-Vastra Gotalandsregionen
Department Name
Hematologi- och onkologiavdelning
Contact Person Name
Ulf-Henrik Mellqvist
Site Name
Karolinska University Hospital (additional site)
Department Name
Hematologi Mottagning
Contact Person Name
Karin Larsson
Site Name
Soedersjukhuset AB
Department Name
Hematologimottagningen
Contact Person Name
Olga Stromberg

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
ESMS Global Limited
Responsibilities
Centralized 24-Hour Emergency System eSMS
Name
Icon Clinical Research Limited
Responsibilities
IMP/NIMP/Device preparation and Home administration
Name
Endpoint Clinical Inc.
Responsibilities
sponsorDuties code 3 (role listed)
Name
Eresearchtechnology Inc.
Responsibilities
sponsorDuties code 7 (role listed)

Third parties

  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System eSMS (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"ApoEx AB","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Keosys","duties_or_roles":"Central Medical Reading or Imaging Reading (sponsorDuties code 15)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Sweden","full_name":"Vaestra Goetalandsregionen","duties_or_roles":"sponsorDuties code 14","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Poland","full_name":"Pharmalink Sp. z o.o.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"IMP/NIMP/Device preparation and Home administration (sponsorDuties code 15, value provided)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Sample storage (sponsorDuties code 15, value provided)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Isatuximab
Active Substance
ISATUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous use; Subcutaneous use (On-Body Delivery System for SC)
Route
Intravenous; Subcutaneous
Authorisation Status
prodAuthStatus 1 (marketing authorization information present for some product entries; product dictionaries list EU product identifiers)
Starting Dose
IV: 10 mg/kg (product metadata shows 10 mg/kg); SC: up to 1400 mg (product metadata shows 1400 mg)
Maximum Dose
IV: 10 mg/kg (per product metadata); SC: 1400 mg (per product metadata)
Investigational Product Name
Pomalidomide (Imnovid / JAMP Pomalidomide / Pomalidomide Adalvo)
Active Substance
POMALIDOMIDE
Modality
Small molecule
Routes Of Administration
Oral use (capsule)
Route
Oral
Authorisation Status
Marketing authorisations listed for various product presentations (multiple productDictionary entries, various MA numbers)
Starting Dose
Up to 4 mg daily (product metadata lists maxDailyDoseAmount = 4 mg)
Frequency
Daily (as per product metadata maxDailyDoseAmount context)
Maximum Dose
4 mg daily (product metadata maxDailyDoseAmount = 4)
Investigational Product Name
Dexamethasone
Active Substance
DEXAMETHASONE
Modality
Small molecule
Routes Of Administration
Oral use (tablet)
Route
Oral
Authorisation Status
Marketing authorisations listed for product presentations (productDictionaryInfo available)
Combination Treatment
Yes

Related trials

Other published trials that may interest you.