Clinical trial • Phase III • Oncology
Lenalidomide for Multiple myeloma
Phase III trial of Lenalidomide for Multiple myeloma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- Small molecule | Monoclonal antibody | Cell therapy
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 28-03-2024
- First CTIS Authorization Date
- 01-05-2024
Trial design
Randomised, dvrd (daratumumab + bortezomib + lenalidomide + dexamethasone) followed by autologous stem cell transplant (asct) (comparator arm); dvrd followed by ciltacabtagene autoleucel (cilta-cel) and lenalidomide therapy (investigational arm). dose/schedule details not specified in the ctis record.-controlled Phase III trial across 45 sites in Czechia, Greece, Norway and others.
- Randomised
- Yes
- Comparator
- DVRd (daratumumab + bortezomib + lenalidomide + dexamethasone) followed by Autologous Stem Cell Transplant (ASCT) (comparator arm); DVRd followed by ciltacabtagene autoleucel (cilta-cel) and lenalidomide therapy (investigational arm). Dose/schedule details not specified in the CTIS record.
- Target Sample Size
- 366
Eligibility
Recruits 366 Vulnerable population flag selected. Trial enrols adults (minimum age 18 years) only; informed consent is obtained using subject information and informed consent forms (multiple L1_ICF Main Adult documents). Specific 'Other Pregnant Partner' ICF documents are provided. Participant information/consent materials are available in multiple country/language versions (examples in the public documents include English, Dutch, French, German, Spanish, Czech, Greek, Norwegian, Swedish). No assent process for minors is indicated (minors are excluded)..
- Vulnerable Population
- Vulnerable population flag selected. Trial enrols adults (minimum age 18 years) only; informed consent is obtained using subject information and informed consent forms (multiple L1_ICF Main Adult documents). Specific 'Other Pregnant Partner' ICF documents are provided. Participant information/consent materials are available in multiple country/language versions (examples in the public documents include English, Dutch, French, German, Spanish, Czech, Greek, Norwegian, Swedish). No assent process for minors is indicated (minors are excluded).
Inclusion criteria
- {"criterion_text":"- 18 years of age or older\n- Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.\n- Measurable disease, as assessed by central laboratory, at screening as defined by any of the following: 1) Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or 2) Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.\n- ECOG performance status of grade 0 or 1\n- Clinical laboratory values within prespecified range as listed in 5.1.1, page 55 of the protocol."}
Exclusion criteria
- {"criterion_text":"- Prior treatment with CAR-T therapy directed at any target.\n- Any prior BCMA target therapy.\n- Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids\n- Received a strong cytochrome P450 (CYP)3A4 inducer within 5 halflives prior to randomization\n- Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.\n- Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM\n- Stroke or seizure within 6 months of signing Informed Consent Form (ICF)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- PFS","definition_or_measurement_approach":""}
- {"endpoint_text":"- Sustained MRD-negative CR, defined as MRD-negative CR for at a minimum 12 months duration, with MRD status determined by NGS with a sensitivity of at least 10-5","definition_or_measurement_approach":"MRD status determined by NGS with a sensitivity of at least 10-5"}
Secondary endpoints
- {"endpoint_text":"- Overall response (PR or better) status and CR or better status","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall MRD-negative CR with a sensitivity of at least 10-5","definition_or_measurement_approach":"MRD assessed by NGS with sensitivity ≥10-5"}
- {"endpoint_text":"- Time to subsequent antimyeloma therapy","definition_or_measurement_approach":""}
- {"endpoint_text":"- PFS on next-line therapy (PFS2)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence, severity, and type of AEs, clinical laboratory results, and other safety parameters","definition_or_measurement_approach":""}
- {"endpoint_text":"- OS","definition_or_measurement_approach":""}
- {"endpoint_text":"- PK and pharmacodynamic markers by protein, DNA, or RNA analyses, including but not limited to, systemic inflammatory cytokine concentrations, markers of CAR-T cell expansion (proliferation) and persistence via monitoring of cilta-cel-positive cellular concentrations, and cilta-cel transgene levels","definition_or_measurement_approach":"PK and pharmacodynamic markers measured by protein/DNA/RNA analyses including systemic inflammatory cytokine concentrations and CAR-T expansion/persistence (cilta-cel-positive cellular concentrations and transgene levels)"}
- {"endpoint_text":"- Mean change from baseline in the EORTC-QLQ-C30, MySIm-Q, and EQ-5D-5L subscale scores and the PROCTCAE items","definition_or_measurement_approach":"PRO instruments: EORTC-QLQ-C30, MySIm-Q, EQ-5D-5L and PRO-CTCAE"}
- {"endpoint_text":"- Time to improvement or worsening of symptoms, functioning, and overall well-being","definition_or_measurement_approach":""}
- {"endpoint_text":"- Improvement or worsening in the EORTC-QLQ- C30 and MySIm-Q subscale scores using the PGIS to calculate the meaningful change threshold","definition_or_measurement_approach":"Use PGIS to calculate meaningful change thresholds for EORTC-QLQ-C30 and MySIm-Q subscales"}
- {"endpoint_text":"- Presence of RCL","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 366
- Recruitment Window Months
- 180
- Consent Approach
- Informed consent is obtained from each adult participant using subject information and informed consent forms (L1_ICF Main Adult and related L1/L2 documents). Country-specific ICFs and patient-facing information documents are provided (multiple language versions available in the public documents list, e.g., English, Dutch, French, German, Spanish, Czech, Greek, Norwegian, Swedish). Specific 'Other Pregnant Partner' information/ICF documents are also available.
Geography
- Total Number Of Sites
- 45
- Total Number Of Participants
- 440
Czechia
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 534
- Number Of Sites
- 5
- Number Of Participants
- 41
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Z97CZ10004: I. Interni klinika - klinika hematologie VFN a 1. LF UK v Praze
- Principal Investigator Name
- Ivan Spicka
- Principal Investigator Email
- spicka@cesnet.cz
- Contact Person Name
- Ivan Spicka
- Contact Person Email
- spicka@cesnet.cz
- Site Name
- Fakultni Nemocnice Plzen
- Department Name
- Z97CZ10005: Hematologicko-onkologicke odd.
- Principal Investigator Name
- Alexandra Jungova
- Principal Investigator Email
- jungovaa@fnplzen.cz
- Contact Person Name
- Alexandra Jungova
- Contact Person Email
- jungovaa@fnplzen.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Z97CZ10001: Klinika hematoonkologie
- Principal Investigator Name
- Roman Hajek
- Principal Investigator Email
- roman.hajek@fno.cz
- Contact Person Name
- Roman Hajek
- Contact Person Email
- roman.hajek@fno.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Z97CZ10002: Int. hemat. a onkol. klinika
- Principal Investigator Name
- Ludek Pour
- Principal Investigator Email
- pour.ludek@fnbrno.cz
- Contact Person Name
- Ludek Pour
- Contact Person Email
- pour.ludek@fnbrno.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Z97CZ10003: IV. interni hematologicka klinika
- Principal Investigator Name
- Jakub Radocha
- Principal Investigator Email
- jakub.radocha@centrum.cz
- Contact Person Name
- Jakub Radocha
- Contact Person Email
- jakub.radocha@centrum.cz
Greece
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 09-10-2025
- Processing Time Days
- 535
- Number Of Sites
- 2
- Number Of Participants
- 23
Sites
- Site Name
- Geniko Nosokomeio Thessalonikis George Papanikolaou
- Department Name
- Z97GR10001:Hematology and HCT unit
- Principal Investigator Name
- Ioanna Sakellari
- Principal Investigator Email
- ioannamarilena@gmail.com
- Contact Person Name
- Ioanna Sakellari
- Contact Person Email
- ioannamarilena@gmail.com
- Site Name
- Alexandra Hospital
- Department Name
- Z97GR10002:Clinical Therapeutics
- Principal Investigator Name
- Evangelos Terpos
- Principal Investigator Email
- eterpos@med.uoa.gr
- Contact Person Name
- Evangelos Terpos
- Contact Person Email
- eterpos@med.uoa.gr
Norway
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 09-10-2025
- Processing Time Days
- 535
- Number Of Sites
- 1
- Number Of Participants
- 18
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Z97NO10001: Avdeling for blodsykdommer
- Principal Investigator Name
- Ingerid Weum Abrahamsen
- Principal Investigator Email
- inabra@ous-hf.no
- Contact Person Name
- Ingerid Weum Abrahamsen
- Contact Person Email
- inabra@ous-hf.no
Belgium
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 13-10-2025
- Processing Time Days
- 539
- Number Of Sites
- 4
- Number Of Participants
- 40
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Marie Vercruyssen
- Principal Investigator Email
- Marie.Vercruyssen@bordet.be
- Contact Person Name
- Marie Vercruyssen
- Contact Person Email
- Marie.Vercruyssen@bordet.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Z97BE10004;Hematology
- Principal Investigator Name
- Nicolas KINT
- Principal Investigator Email
- nicolas.kint@uzgent.be
- Contact Person Name
- Nicolas KINT
- Contact Person Email
- nicolas.kint@uzgent.be
- Site Name
- Antwerp University Hospital
- Department Name
- Z97BE10001;Hematology
- Principal Investigator Name
- Sebastien Anguille
- Principal Investigator Email
- sebastien.anguille@uza.be
- Contact Person Name
- Sebastien Anguille
- Contact Person Email
- sebastien.anguille@uza.be
- Site Name
- UZ Leuven
- Department Name
- Z97BE10003;Hematology
- Principal Investigator Name
- Michel Delforge
- Principal Investigator Email
- Michel.delforge@uzleuven.be
- Contact Person Name
- Michel Delforge
- Contact Person Email
- Michel.delforge@uzleuven.be
Netherlands
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 532
- Number Of Sites
- 5
- Number Of Participants
- 81
Sites
- Site Name
- Radboud universitair medisch centrum / RADBOUDUMC
- Department Name
- Z97NL10002: Hematology
- Principal Investigator Name
- Elizabeth de Kort
- Principal Investigator Email
- Elizabeth.deKort@radboudumc.nl
- Contact Person Name
- Elizabeth de Kort
- Contact Person Email
- Elizabeth.deKort@radboudumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Z97NL10003: Hematology
- Principal Investigator Name
- Monique Minnema
- Principal Investigator Email
- m.c.minnema@umcutrecht.nl
- Contact Person Name
- Monique Minnema
- Contact Person Email
- m.c.minnema@umcutrecht.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Z97NL10004: Hematology
- Principal Investigator Name
- Wilfried Roeloffzen
- Principal Investigator Email
- w.w.h.roeloffzen@umcg.nl
- Contact Person Name
- Wilfried Roeloffzen
- Contact Person Email
- w.w.h.roeloffzen@umcg.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Z97NL10001: Hematology
- Principal Investigator Name
- Annemiek Broijl
- Principal Investigator Email
- a.broyl@erasmusmc.nl
- Contact Person Name
- Annemiek Broijl
- Contact Person Email
- a.broyl@erasmusmc.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Z97NL10005: Hematology
- Principal Investigator Name
- Niels van de Donk
- Principal Investigator Email
- n.vandedonk@amsterdamumc.nl
- Contact Person Name
- Niels van de Donk
- Contact Person Email
- n.vandedonk@amsterdamumc.nl
France
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 10-10-2025
- Processing Time Days
- 536
- Number Of Sites
- 7
- Number Of Participants
- 29
Sites
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Z97FR10005: Service d'Hématologie Clinique
- Principal Investigator Name
- Lionel Karlin
- Principal Investigator Email
- lionel.karlin@chu-lyon.fr
- Contact Person Name
- Lionel Karlin
- Contact Person Email
- lionel.karlin@chu-lyon.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Z97FR10004: Hématologie
- Principal Investigator Name
- Aurore Perrot
- Principal Investigator Email
- perrot.aurore@iuct-oncopole.fr
- Contact Person Name
- Aurore Perrot
- Contact Person Email
- perrot.aurore@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Z97FR10002: Service des Maladies du Sang
- Principal Investigator Name
- Salomon MANIER
- Principal Investigator Email
- salomon.manier@chru-lille.fr
- Contact Person Name
- Salomon MANIER
- Contact Person Email
- salomon.manier@chru-lille.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Z97FR10001: Immunologie-Hematologie Clinique
- Principal Investigator Name
- Bertrand MANIER
- Principal Investigator Email
- bertrand.arnulf@aphp.fr
- Contact Person Name
- Bertrand MANIER
- Contact Person Email
- bertrand.arnulf@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Z97FR10006: Service d’Hématologie et Thérapie Cellulaire
- Principal Investigator Name
- Xavier Leleu
- Principal Investigator Email
- xavier.leleu@chu-poitiers.fr
- Contact Person Name
- Xavier Leleu
- Contact Person Email
- xavier.leleu@chu-poitiers.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- Z97FR10007: Service d'Hématologie Clinique et Thérapie Cellulaire
- Principal Investigator Name
- Mohamad Mohty
- Principal Investigator Email
- mohamad.mohty@inserm.fr
- Contact Person Name
- Mohamad Mohty
- Contact Person Email
- mohamad.mohty@inserm.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Z97FR10003: Hématologie Clinique
- Principal Investigator Name
- Philippe Moreau
- Principal Investigator Email
- philippe.moreau@chu-nantes.fr
- Contact Person Name
- Philippe Moreau
- Contact Person Email
- philippe.moreau@chu-nantes.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 560
- Number Of Sites
- 6
- Number Of Participants
- 51
Sites
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- Z97DE10006: University Cancer Center Dpt.
- Principal Investigator Name
- Vladan Vucinic
- Principal Investigator Email
- vladan.vucinic@medizin.uni-leipzig.de
- Contact Person Name
- Vladan Vucinic
- Contact Person Email
- vladan.vucinic@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Z97DE10002:Medizinische Klinik und Poliklinik II
- Principal Investigator Name
- Hermann Einsele
- Principal Investigator Email
- einsele_h@ukw.de
- Contact Person Name
- Hermann Einsele
- Contact Person Email
- einsele_h@ukw.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Z97DE10001: Onkologie, Hämatologie, Klinische Immunologie, Rheumatologie und Pulmologie
- Principal Investigator Name
- Britta Besemer
- Principal Investigator Email
- britta.besemer@med.uni-tuebingen
- Contact Person Name
- Britta Besemer
- Contact Person Email
- britta.besemer@med.uni-tuebingen
- Site Name
- University Hospital Cologne AöR
- Department Name
- Z97DE10004: Innere Medizin I
- Principal Investigator Name
- Christoph Scheid
- Principal Investigator Email
- c.scheid@uni-koeln.de
- Contact Person Name
- Christoph Scheid
- Contact Person Email
- c.scheid@uni-koeln.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Z97DE10003: Abteilung Innere Medizin V, Haematologie, Onkologie, Rheumatologie
- Principal Investigator Name
- Marc Steffen Raab
- Principal Investigator Email
- marc.raab@med.uni-heidelberg.de
- Contact Person Name
- Marc Steffen Raab
- Contact Person Email
- marc.raab@med.uni-heidelberg.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Z97DE10007: Innere Medizin
- Principal Investigator Name
- Katja Weisel
- Principal Investigator Email
- k.weisel@uke.de
- Contact Person Name
- Katja Weisel
- Contact Person Email
- k.weisel@uke.de
Spain
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 561
- Number Of Sites
- 11
- Number Of Participants
- 141
Sites
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Z97ES10010: Hematología
- Principal Investigator Name
- Paula Rodríguez Otero
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodríguez Otero
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Z97ES10007: Hematología
- Principal Investigator Name
- María Mateos Manteca
- Principal Investigator Email
- mvmateos@usal.es
- Contact Person Name
- María Mateos Manteca
- Contact Person Email
- mvmateos@usal.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Z97ES10005: Hematología
- Principal Investigator Name
- Maria Jesus Blanchard Rodriguez
- Principal Investigator Email
- mariajesus.blanchard@salud.madrid.org
- Contact Person Name
- Maria Jesus Blanchard Rodriguez
- Contact Person Email
- mariajesus.blanchard@salud.madrid.org
- Site Name
- Institut Catala D'oncologia
- Department Name
- Z97ES10011: Hematologia
- Principal Investigator Name
- Anna Sureda Balari
- Principal Investigator Email
- asureda@iconcologia.net
- Contact Person Name
- Anna Sureda Balari
- Contact Person Email
- asureda@iconcologia.net
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Z97ES10004: Hematología
- Principal Investigator Name
- Marta González Pérez
- Principal Investigator Email
- marta.sonia.gonzalez.perez@sergas.es
- Contact Person Name
- Marta González Pérez
- Contact Person Email
- marta.sonia.gonzalez.perez@sergas.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Z97ES10006: Hematología y Hemoterápia
- Principal Investigator Name
- Joaquin Martinez Lopez
- Principal Investigator Email
- jmarti01@med.ucm.es
- Contact Person Name
- Joaquin Martinez Lopez
- Contact Person Email
- jmarti01@med.ucm.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Z97ES10009: Hematologia y Hemoterapia
- Principal Investigator Name
- Juan Reguera Ortega
- Principal Investigator Email
- juanl.reguera.sspa@juntadeandalucia.es
- Contact Person Name
- Juan Reguera Ortega
- Contact Person Email
- juanl.reguera.sspa@juntadeandalucia.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Z97ES10002: Hematología
- Principal Investigator Name
- Carlos Fernández De Larrea Rodríguez
- Principal Investigator Email
- cfernan1@clinic.cat
- Contact Person Name
- Carlos Fernández De Larrea Rodríguez
- Contact Person Email
- cfernan1@clinic.cat
- Site Name
- Institut Catala D'oncologia (Badalona)
- Department Name
- Z97ES10008: Hematología
- Principal Investigator Name
- Albert Oriol-Rocafiguera
- Principal Investigator Email
- aoriol@iconcologia.net
- Contact Person Name
- Albert Oriol-Rocafiguera
- Contact Person Email
- aoriol@iconcologia.net
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Z97ES10001: Hematología
- Principal Investigator Name
- Javier De la Rubia Comos
- Principal Investigator Email
- delarubia_jav@gva.es
- Contact Person Name
- Javier De la Rubia Comos
- Contact Person Email
- delarubia_jav@gva.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Z97ES10003: Hematologia
- Principal Investigator Name
- Cristina Encinas Rodriguez
- Principal Investigator Email
- cristina.encinas@salud.madrid.org
- Contact Person Name
- Cristina Encinas Rodriguez
- Contact Person Email
- cristina.encinas@salud.madrid.org
Sweden
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 13-01-2026
- Processing Time Days
- 631
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Z97SE10002:Sektionen för Hematologi och K
- Principal Investigator Name
- Markus Hansson
- Principal Investigator Email
- markus.hansson.2@gu.se
- Contact Person Name
- Markus Hansson
- Contact Person Email
- markus.hansson.2@gu.se
- Site Name
- University Of Skane
- Department Name
- Z97SE10001:Outpatient department
- Principal Investigator Name
- Stina Wichert
- Principal Investigator Email
- stina.wichert@skane.se
- Contact Person Name
- Stina Wichert
- Contact Person Email
- stina.wichert@skane.se
- Site Name
- Linkoping University Hospital Region Ostergotland
- Department Name
- Z97SE10003:Hematologiska Kliniken
- Principal Investigator Name
- Love Tätting
- Principal Investigator Email
- Love.Tatting@regionostergotland.se
- Contact Person Name
- Love Tätting
- Contact Person Email
- Love.Tatting@regionostergotland.se
- Site Name
- Uppsala University Hospital
- Department Name
- Z97SE10004:Oncology
- Principal Investigator Name
- Kristina Carlson
- Principal Investigator Email
- Kristina.Carlson@akademiska.se
- Contact Person Name
- Kristina Carlson
- Contact Person Email
- Kristina.Carlson@akademiska.se
Sponsor
Primary sponsor
- Full Name
- European Myeloma Network B.V.
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Netherlands
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- Codes listed in sponsorDuties (1,12,6,7,8) - contact: clinicaltrial.enquiries@parexel.com
- Name
- Excelya Greece CRO Single Member S.A.
- Responsibilities
- Codes listed in sponsorDuties (1,12) - contact: clinicalRa-greece@excelya.com
Third parties
- {"country":"United States","full_name":"Charles River Laboratories International Inc.","duties_or_roles":"SPM (Second Primary Malignancy)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"Cytokines (serum)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eurofins Pharma Bioanalytics Services US Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"Immunogenicity","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":": PK Daratumumab, Immunogenicity Daratumumab, Sample storage time: until end of study.","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Amsterdam UMC Stichting","duties_or_roles":"Clinical haematology, Histopathology","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"Immunophenotyping, Flowcytometry (bone marrow aspirate)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Ospedale San Raffaele S.r.l.","duties_or_roles":"scRNAseq (single cell RNA sequencing), TCR (T Cell receptor) sequencing, cfMeDIP (Cell-free methylated DNA immunoprecipitation) sequencing, LiBIS (liquid biopsy integration site) seqencing, IS (Integration Site) sequencing","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Netherlands","full_name":"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","duties_or_roles":"Clinical haematology, Histopathology","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"MRD negativity status","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"New (Second) primary malignancy, Biopsy, Fish testing, PBMC processing, BMMC processing.","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"RCL Testing","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central labs","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Julius-Maximilians-Universitaet Wuerzburg","duties_or_roles":"Clinical haematology, Histopathology","organisation_type":"Educational Institution"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Buccal Swab scRNAseq, WES, CyTOF, plasma and BM","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Italy","full_name":"Universita' Degli Studi Di Torino","duties_or_roles":"Clinical haematology, Histopathology","organisation_type":"Educational Institution"}
- {"country":"United States","full_name":"Phenopath Laboratories PLLC","duties_or_roles":": BIOPSY KIT : New malignancies (SPM), Plasmacytoma, Neurotoxicity event or any other time a biopsy","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"IVRS30 – treatment randomisation","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Biomarkers","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Spain","full_name":"Complexo Hospitalario Universitario De Santiago","duties_or_roles":"Laboratory analysis: GrHeCo-Xen","organisation_type":"Hospital/Clinic/Other health care facility"}
Co-sponsors
- Emn Trial Office S.r.l. Impresa Sociale
Investigational products
- Investigational Product Name
- Lenalidomide Accord (multiple strengths)
- Active Substance
- Lenalidomide
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- 2.5 mg | 5 mg | 15 mg | 20 mg | 25 mg
- Maximum Dose
- 25 mg per day
- Investigational Product Name
- DARZALEX 1800 mg solution for injection
- Active Substance
- Daratumumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Dose Levels
- 1800 mg
- Maximum Dose
- 1800 mg
- Investigational Product Name
- CARVYKTI (ciltacabtagene autoleucel)
- Active Substance
- Ciltacabtagene autoleucel
- Modality
- Cell therapy
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Dose Levels
- 3.2 × 10^6 – 1.0 × 10^8 cells dispersion for infusion
- 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 (dose expressed in mg/m2)
- Authorisation Status
- Authorised
- Dose Levels
- 3.5 mg (powder for solution)
- Maximum Dose
- 1.3 mg/m2
- Investigational Product Name
- Dexamethasone (2 mg / 4 mg tablets)
- Active Substance
- Dexamethasone
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- 2 mg | 4 mg
- Maximum Dose
- 40 mg per day
- Combination Treatment
- Yes
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