Clinical trial • Phase III • Oncology

ISATUXIMAB for Smoldering multiple myeloma | Plasma cell myeloma

Phase III trial of ISATUXIMAB for Smoldering multiple myeloma | Plasma cell myeloma.

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Smoldering multiple myeloma | Plasma cell myeloma
Trial Stage: Phase III
Drug Modality: Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date: 17-11-2023
First CTIS Authorization Date: 14-02-2024

Trial design

Randomised, open-label, isatuximab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone (control)., adaptive Phase III trial in Poland, Lithuania, France and others.

Randomised: Yes
Open Label: Yes
Comparator: Isatuximab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone (control).
Adaptive: True: Study includes a Safety run-in Part to confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone; no additional adaptive decision rules described in provided materials.
Single Multiple Or Escalation Dose Combined: Yes
Target Sample Size: 258

Eligibility

Recruits 258 Vulnerable population flag is selected. Participants must be adults (≥18) and "Capable of giving voluntary written informed consent"; consent is obtained from the participant. Partner/pregnancy information and partner-specific consent/information documents are included in the documentation set. No paediatric assent procedures (participants must be ≥18)..

Pregnancy Exclusion: - Women of childbearing potential or male participant with women of childbearing potential who do not agree to use a highly effective method of birth control
Vulnerable Population: Vulnerable population flag is selected. Participants must be adults (≥18) and "Capable of giving voluntary written informed consent"; consent is obtained from the participant. Partner/pregnancy information and partner-specific consent/information documents are included in the documentation set. No paediatric assent procedures (participants must be ≥18).

Inclusion criteria

{"criterion_text":"-Participant must be at least 18 years of age inclusive or older"}
{"criterion_text":"-Participants who are diagnosed within 5 years with SMM (per International Myeloma Working Group [IMWG] criteria), defined as serum M-protein ≥30 g/L or urinary M- protein ≥500 mg per 24 hour or both, and/or clonal bone marrow plasma cells (BMPCs) 10% to <60%, and absence of myeloma defining events or other related conditions and with high-risk SMM"}
{"criterion_text":"-Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or 2"}
{"criterion_text":"-Capable of giving voluntary written informed consent"}
{"criterion_text":"-Absolute neutrophil count (ANC) ≥1000/µL (1 × 109/L)"}
{"criterion_text":"-Platelets ≥50,000/µL (50 × 109/L)"}
{"criterion_text":"-Total bilirubin ≤3 mg/dL (except Gilbert syndrome, in which direct bilirubin should be - ≤5 mg/dL)."}
{"criterion_text":"-Alanine aminotransferase ≤3× upper limit of normal (ULN), aspartate aminotransferase ≤ 3 × ULN."}

Exclusion criteria

{"criterion_text":"-Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Increased calcium levels: Corrected serum calcium >1 mg/dL above the ULN or >11 mg/dL"}
{"criterion_text":"-Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Serum involved/uninvolved FLC ratio ≥100 and an involved FLC ≥100mg/L"}
{"criterion_text":"-Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Whole body magnetic resonance imaging (WB-MRI) or positron emission tomography computed tomography (PET-CT) with more than 1 bone focal lesion (≥5 mm in diameter by MRI)"}
{"criterion_text":"- Clinically significant cardiac or vascular disease within 3 months prior to randomization, e.g. Myocardial Infarction; Unstable Angina; Coronary (e.g. Coronary Artery Bypass Graft, Percutaneous Coronary Intervention) or peripheral artery revascularization, Left Ventricular Ejection Fraction <40%, Heart Failure NYHA III-IV, Stroke, Transient Ischemic Attack, Pulmonary Embolism, other thromboembolic event, cardiac arrhythmia (Grade 3 or higher by NCI-CTCAE Version 5.0)"}
{"criterion_text":"Primary systemic and localized amyloid light chain (AL) amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), standard risk smoldering myeloma, soft-tissue plasmacytoma, and symptomatic myeloma"}
{"criterion_text":"- Uncontrolled infection within 28 days prior to randomization in Phase 3 or first study intervention administration in safety run-in"}
{"criterion_text":"Patient can be eligible if anti-HBc Immunoglubolin G (IgG) positive (with or without positive anti-HBs) but HBsAg and HBV DNA are negative. If anti-HBV therapy in relation with prior infection was started before initiation of IMP, the anti-HBV therapy and monitoring should continue throughout the study treatment period"}
{"criterion_text":"Patients with negative HBsAg and positive HBV DNA observed during screening period will be evaluated by a specialist for start of anti-viral treatment: study treatment could be proposed if HBV DNA becomes negative and all the other study criteria are still met"}
{"criterion_text":"- Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A (defined as positive hepatitis A antigen or positive IgM). HIV serology at screening will be tested for German participants and any other country where required as per local regulations and serology hepatitis B and C at screening will be tested for all participants."}
{"criterion_text":"Uncontrolled or active hepatitis B virus (HBV) infection: Patients with positive Hepatitis B surface antigen (HBsAg) and/or HBV Deoxyribonucleic acid(DNA)"}
{"criterion_text":"Patients with antiviral therapy for HCV started before initiation of IMP and positive HCV antibodies are eligible. The antiviral therapy for HCV should continue throughout the treatment period until seroconversion"}
{"criterion_text":"-Prior exposure to approved or investigational treatments for SMM or multiple myeloma (MM) (including but not limited to conventional chemotherapies, immunomodulatory imid drugs, or Proteasome inhibitors); concurrent use of bisphosphonates or receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor denosumab is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted"}
{"criterion_text":"-Patients with positive anti-HCV and undetectable HCV ribonucleic acid (RNA) without antiviral therapy for HCV are eligible"}
{"criterion_text":"- Malabsorption syndrome or any condition that can significantly impact the absorption of lenalidomide"}
{"criterion_text":"- Any of the following within 3 months prior to randomization (or first study intervention administration in safety run-in cohort): treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis"}
{"criterion_text":"-Received treatment (eg surgery, radiotherapy, medication) for a malignancy within 3 years of randomization (or first study intervention administration in safety run-in cohort)"}
{"criterion_text":"-Active hepatitis C virus (HCV) infection: positive HCV RNA and negative anti-HCV"}
{"criterion_text":"- Ongoing treatment with corticosteroids with a dose >10 mg prednisone or equivalent per day at the time of randomization (or first study intervention administration in safety run-in cohort)"}
{"criterion_text":"-Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Renal insufficiency: Determined by glomerular filtration rate (GFR) <40 mL/min/1.73 m²(Modification of Diet in Renal Disease [MDRD] Formula) or serum creatinine >2 mg/dL"}
{"criterion_text":"- Women of childbearing potential or male participant with women of childbearing potential who do not agree to use a highly effective method of birth control"}
{"criterion_text":"- Vaccination with a live vaccine 4 weeks before the start of the study drug. Seasonal flu vaccines that do not contain live virus are permitted"}
{"criterion_text":"-Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Anemia (hemoglobin 2 g/dL below lower limit of normal or <10 g/dL or both). Transfusionsupport or concurrent treatment with erythropoietin stimulating agents is not permitted"}
{"criterion_text":"-Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): ≥ 1 bone lytic lesion of ≥5mm in size"}
{"criterion_text":"-Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): BMPCs ≥60%"}

Endpoints

Primary endpoints

{"endpoint_text":"-Number of participants with treatment-emergent: adverse events (AEs) and serious adverse events - Safety Run-in Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Plasma concentration of isatuximab during the treatment period: - Safety Run-in Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Receptor density/receptor occupancy - Safety Run-in Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Progression-free survival (PFS) - Randomized Phase 3 Part","definition_or_measurement_approach":""}

Secondary endpoints

{"endpoint_text":"-Overall response rate (ORR) - Safety Run-in Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Duration of response (DOR) - Safety Run-in Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Minimal residual disease (MRD) negativity -Safety Run-in Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Time to diagnostic (SLiM CRAB) progression or death - Safety Run-in Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Time to first-line treatment for multiple myeloma (MM) - Safety Run-in Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Number of participants with anti-drug antibodies (ADA) against isatuximab - Safety Run-in Part","definition_or_measurement_approach":""}
{"endpoint_text":"-PFS in participants with chromosomal abnormalities - Safety Run-In Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Overall Survival (OS) in participants with chromosomal abnormalities - Safety Run-In Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Minimal residual disease (MRD) negativity – Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Sustained MRD negativity - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Second PFS (PFS2) - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-OS - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Complete response (CR) rate - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Overall Response Rate (ORR) – Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Duration of response (DOR) – Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Time to diagnostic (SLiM CRAB) progression - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Time to biochemical progression - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Time to first-line treatment for MM- Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-PFS in participants with chromosomal abnormalities - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-OS in participants with chromosomal abnormalities - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Number of participants with Treatment- emergent adverse events (AEs) and serious adverse events - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Plasma concentration of isatuximab (Ctrough)- Safety Run-in and Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Concentration observed at the end of intravenous infusion.(Ceoi)- Safety Run-in Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Number of participants with Incidence of anti- drug antibodies (ADA) against isatuximab-","definition_or_measurement_approach":""}
{"endpoint_text":"-European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 - Randomized Phase 3","definition_or_measurement_approach":""}
{"endpoint_text":"-EORTC QLQ-MY20 - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-EQ-5D-5L - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Randomized Phase 3: HRUPQ - Randomized Phase 3 Part","definition_or_measurement_approach":""}
{"endpoint_text":"-Patient's Qualitative Assessment of Treatment Version 2 (PQAT-v2) - Randomized Phase 3 Part","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size: 258
Recruitment Window Months: 167
Consent Approach: Informed consent must be provided in writing by the participant ("Capable of giving voluntary written informed consent"). ICF materials and partner/pregnancy information documents are provided; subject information and consent forms are available in multiple languages (examples in documentation: English, French, Spanish, Greek, Hungarian, Polish, Czech, Italian, German, Lithuanian, Danish, Norwegian and others as per local country documents).

Geography

Total Number Of Sites: 41
Total Number Of Participants: 272

Poland

Earliest CTIS Part Ii Submission Date: 06-12-2023
Latest Decision Or Authorization Date: 06-10-2025
Processing Time Days: 664
Number Of Sites: 2
Number Of Participants: 18

Sites

Site Name: Uniwersyteckie Centrum Kliniczne
Department Name: Klinika Hematologii i Transplantologii
Principal Investigator Name: Agata Tyczynska
Principal Investigator Email: atyczynska@uck.gda.pl
Contact Person Name: Agata Tyczynska
Contact Person Email: atyczynska@uck.gda.pl

Site Name: Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name: Oddzial Hematologii
Principal Investigator Name: Pawel Robak
Principal Investigator Email: robaktad@onet.pl
Contact Person Name: Pawel Robak
Contact Person Email: robaktad@onet.pl

Lithuania

Earliest CTIS Part Ii Submission Date: 06-12-2023
Latest Decision Or Authorization Date: 02-10-2025
Processing Time Days: 660
Number Of Sites: 1
Number Of Participants: 10

Sites

Site Name: Vilniaus universiteto ligonine Santaros klinikos VšĮ
Department Name: Hematology, Oncology and Transfusion Medicine Center
Principal Investigator Name: Valdas Peceliunas
Principal Investigator Email: valdas.peceliunas@santa.lt
Contact Person Name: Valdas Peceliunas
Contact Person Email: valdas.peceliunas@santa.lt

France

Earliest CTIS Part Ii Submission Date: 06-12-2023
Latest Decision Or Authorization Date: 01-10-2025
Processing Time Days: 659
Number Of Sites: 9
Number Of Participants: 40

Sites

Site Name: Centre Hospitalier De La Cote Basque
Department Name: Service d'hematologie
Principal Investigator Name: Julie Gay
Principal Investigator Email: jgay@ch-cotebasque.fr
Contact Person Name: Julie Gay
Contact Person Email: jgay@ch-cotebasque.fr

Site Name: Centre Hospitalier Universitaire De Poitiers
Department Name: Service hematologie et Therapie 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: Centre Hospitalier Universitaire De Rennes
Department Name: Service Hematologie
Principal Investigator Name: Olivier DECAUX
Principal Investigator Email: olivier.decaux@chu-rennes.fr
Contact Person Name: Olivier DECAUX
Contact Person Email: olivier.decaux@chu-rennes.fr

Site Name: Centre Hospitalier Universitaire De Lille
Department Name: Département Hématologie
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 Antoine
Department Name: Service hematologie et Therapie 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: Assistance Publique Hopitaux De Paris
Department Name: Hematologie
Principal Investigator Name: Laurent Garderet
Principal Investigator Email: laurent.garderet@aphp.fr
Contact Person Name: Laurent Garderet
Contact Person Email: laurent.garderet@aphp.fr

Site Name: Centre Hospitalier Departemental Vendee
Department Name: Onco-hématologie
Principal Investigator Name: Mourad Tiab
Principal Investigator Email: mourad.tiab@chd-vendee.fr
Contact Person Name: Mourad Tiab
Contact Person Email: mourad.tiab@chd-vendee.fr

Site Name: Centre Hospital Region Metz Thionville
Department Name: Service hematologie
Principal Investigator Name: Veronique DORVAUX
Principal Investigator Email: v.dorvaux@chr-metz-thionville.fr
Contact Person Name: Veronique DORVAUX
Contact Person Email: v.dorvaux@chr-metz-thionville.fr

Site Name: Centre Hospitalier Universitaire Grenoble Alpes
Department Name: Hématologie Clinique
Principal Investigator Name: Clara MARIETTE
Principal Investigator Email: cmariette@chu-grenoble.fr
Contact Person Name: Clara MARIETTE
Contact Person Email: cmariette@chu-grenoble.fr

Spain

Earliest CTIS Part Ii Submission Date: 06-12-2023
Latest Decision Or Authorization Date: 02-10-2025
Processing Time Days: 660
Number Of Sites: 7
Number Of Participants: 49

Sites

Site Name: Hospital De La Santa Creu I Sant Pau
Department Name: Servicio de Hematologia
Principal Investigator Name: Miquel Granell Gorrochategui
Principal Investigator Email: mgranell@santpau.cat
Contact Person Name: Miquel Granell Gorrochategui
Contact Person Email: mgranell@santpau.cat

Site Name: Hospital Clinico Universitario Lozano Blesa
Department Name: Servicio de Hematologia
Principal Investigator Name: Luis Ignacio Sancho
Principal Investigator Email: lisancho@salud.aragon.es
Contact Person Name: Luis Ignacio Sancho
Contact Person Email: lisancho@salud.aragon.es

Site Name: Clinica Universidad De Navarra
Department Name: Servicio de Hematologia
Principal Investigator Name: Paula Rodriguez Otero
Principal Investigator Email: paurodriguez@unav.es
Contact Person Name: Paula Rodriguez Otero
Contact Person Email: paurodriguez@unav.es

Site Name: Hospital Universitario De Salamanca
Department Name: Servicio de Hematologia
Principal Investigator Name: Victoria Mateos
Principal Investigator Email: mvmateos@usal.es
Contact Person Name: Victoria Mateos
Contact Person Email: mvmateos@usal.es

Site Name: Hospital Universitario 12 De Octubre
Department Name: Servicio de Hematologia
Principal Investigator Name: Joaquin Martinez
Principal Investigator Email: jmarti01@med.ucm.es
Contact Person Name: Joaquin Martinez
Contact Person Email: jmarti01@med.ucm.es

Site Name: Hospital Clinic De Barcelona
Department Name: Servicio de Hematologia
Principal Investigator Name: Laura Rosinol Dachs
Principal Investigator Email: lrosinol@clinic.cat
Contact Person Name: Laura Rosinol Dachs
Contact Person Email: lrosinol@clinic.cat

Site Name: Hospital Universitario Dr Peset Aleixandre
Department Name: Servicio de Hematologia
Principal Investigator Name: M Paz Ribas
Principal Investigator Email: ribas_paz@gva.es
Contact Person Name: M Paz Ribas
Contact Person Email: ribas_paz@gva.es

Czechia

Earliest CTIS Part Ii Submission Date: 06-12-2023
Latest Decision Or Authorization Date: 01-10-2025
Processing Time Days: 659
Number Of Sites: 5
Number Of Participants: 20

Sites

Site Name: Vseobecna Fakultni Nemocnice V Praze
Department Name: I. interni klinika
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 Hradec Kralove
Department Name: IV. interni hematologicka klinika
Principal Investigator Name: Vladimir Maisnar
Principal Investigator Email: vladimir.maisnar@fnhk.cz
Contact Person Name: Vladimir Maisnar
Contact Person Email: vladimir.maisnar@fnhk.cz

Site Name: Fakultni Nemocnice Ostrava
Department Name: 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: Interni hematoonkologicka 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: University Hospital Olomouc
Department Name: Hemato-onkologicka klinika
Principal Investigator Name: Jiri Minarik
Principal Investigator Email: abretina@email.cz
Contact Person Name: Jiri Minarik
Contact Person Email: abretina@email.cz

Denmark

Earliest CTIS Part Ii Submission Date: 06-12-2023
Latest Decision Or Authorization Date: 01-10-2025
Processing Time Days: 659
Number Of Sites: 3
Number Of Participants: 11

Sites

Site Name: Rigshospitalet
Department Name: Clinical Trial Unit 2081
Principal Investigator Name: N. Emil Hermansen
Principal Investigator Email: trhd@regionsjaelland.dk
Contact Person Name: N. Emil Hermansen
Contact Person Email: trhd@regionsjaelland.dk

Site Name: Region Sjaelland
Department Name: Hematologisk afd
Principal Investigator Name: Trung Hieu Do
Principal Investigator Email: trhd@regionsjaelland.dk
Contact Person Name: Trung Hieu Do
Contact Person Email: trhd@regionsjaelland.dk

Site Name: Aalborg University Hospital
Department Name: Department of Haematology
Principal Investigator Name: Henrik Gregersen
Principal Investigator Email: henrik.gregersen@rn.dk
Contact Person Name: Henrik Gregersen
Contact Person Email: henrik.gregersen@rn.dk

Germany

Earliest CTIS Part Ii Submission Date: 06-12-2023
Latest Decision Or Authorization Date: 30-09-2025
Processing Time Days: 658
Number Of Sites: 2
Number Of Participants: 7

Sites

Site Name: University Medical Center Hamburg-Eppendorf
Department Name: Universitatsklinikum Hamburg-Eppendorf (#1)
Principal Investigator Name: Katja Weisel
Principal Investigator Email: k.weisel@uke.de
Contact Person Name: Katja Weisel
Contact Person Email: k.weisel@uke.de

Site Name: Universitaetsklinikum Heidelberg AöR
Department Name: Universitatsklinikum Heidelberg( #1)
Principal Investigator Name: Elias Karl Mai
Principal Investigator Email: elias.mai@med.uni-heidelberg.de
Contact Person Name: Elias Karl Mai
Contact Person Email: elias.mai@med.uni-heidelberg.de

Greece

Earliest CTIS Part Ii Submission Date: 06-12-2023
Latest Decision Or Authorization Date: 03-10-2025
Processing Time Days: 661
Number Of Sites: 3
Number Of Participants: 36

Sites

Site Name: Evangelismos S.A.
Department Name: Hematology Clinic
Principal Investigator Name: Sosana Delimpasi
Principal Investigator Email: sodeli@yahoo.com
Contact Person Name: Sosana Delimpasi
Contact Person Email: sodeli@yahoo.com

Site Name: Theageneio Cancer Hospital
Department Name: Hematology Department
Principal Investigator Name: Eirini Katodritou
Principal Investigator Email: eirinikatodritou@gmail.com
Contact Person Name: Eirini Katodritou
Contact Person Email: eirinikatodritou@gmail.com

Site Name: Alexandra Hospital
Department Name: Oncology-Hematology Department
Principal Investigator Name: Meletios-Athanasios Dimopoulos
Principal Investigator Email: mdimop@med.uoa.gr
Contact Person Name: Meletios-Athanasios Dimopoulos
Contact Person Email: mdimop@med.uoa.gr

Hungary

Earliest CTIS Part Ii Submission Date: 06-12-2023
Latest Decision Or Authorization Date: 03-10-2025
Processing Time Days: 661
Number Of Sites: 3
Number Of Participants: 12

Sites

Site Name: Semmelweis University
Department Name: Belgyogyaszati es Hematologiai Klinika
Principal Investigator Name: Zsolt Nagy
Principal Investigator Email: nagy.zsolt@med.semmelweis-univ.hu
Contact Person Name: Zsolt Nagy
Contact Person Email: nagy.zsolt@med.semmelweis-univ.hu

Site Name: Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name: Hematologia Osztaly
Principal Investigator Name: Miklos Egyed
Principal Investigator Email: dregyedmiklos@yahoo.com
Contact Person Name: Miklos Egyed
Contact Person Email: dregyedmiklos@yahoo.com

Site Name: Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name: Hematologiai es Ossejt-transzplantacios Osztaly
Principal Investigator Name: Gabor Mikala
Principal Investigator Email: gmikala@laszlokorhaz.hu
Contact Person Name: Gabor Mikala
Contact Person Email: gmikala@laszlokorhaz.hu

Italy

Earliest CTIS Part Ii Submission Date: 06-12-2023
Latest Decision Or Authorization Date: 03-10-2025
Processing Time Days: 661
Number Of Sites: 4
Number Of Participants: 41

Sites

Site Name: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name: Oncologia
Principal Investigator Name: Claudio Cerchione
Principal Investigator Email: claudio.cerchione@irst.emr.it
Contact Person Name: Claudio Cerchione
Contact Person Email: claudio.cerchione@irst.emr.it

Site Name: Humanitas Research Hospital
Department Name: Oncologia ed Ematologia
Principal Investigator Name: Carmelo Carlo-Stella
Principal Investigator Email: carmelo.carlostella@hunimed.eu
Contact Person Name: Carmelo Carlo-Stella
Contact Person Email: carmelo.carlostella@hunimed.eu

Site Name: Azienda Ospedaliera S Maria Di Terni
Department Name: S. C. Oncoematologia
Principal Investigator Name: Arcangelo Liso
Principal Investigator Email: arcangelo.liso@unipg.it
Contact Person Name: Arcangelo Liso
Contact Person Email: arcangelo.liso@unipg.it

Site Name: Azienda Ospedaliero Universitaria Delle Marche
Department Name: SOD Clinica Ematologica
Principal Investigator Name: Massimo Offidani
Principal Investigator Email: massimo.offidani@ospedaliriuniti.marche.it
Contact Person Name: Massimo Offidani
Contact Person Email: massimo.offidani@ospedaliriuniti.marche.it

Norway

Earliest CTIS Part Ii Submission Date: 06-12-2023
Latest Decision Or Authorization Date: 30-09-2025
Processing Time Days: 658
Number Of Sites: 2
Number Of Participants: 28

Sites

Site Name: Helse Bergen HF
Department Name: Haukeland Universitetssykehus HF( #1)
Principal Investigator Name: Galina Tsykunova
Principal Investigator Email: galina.tsykunova@helse-bergen.no
Contact Person Name: Galina Tsykunova
Contact Person Email: galina.tsykunova@helse-bergen.no

Site Name: Oslo University Hospital HF
Department Name: Poliklinikk, Blodsykdommer bygn 20
Principal Investigator Name: Fredrik Schjesvold
Principal Investigator Email: fredrikschjesvold@gmail.com
Contact Person Name: Fredrik Schjesvold
Contact Person Email: fredrikschjesvold@gmail.com

Sponsor

Primary sponsor

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

Third parties

{"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"LAB LOGISTICS AND ANALYSIS","organisation_type":"Pharmaceutical company"}
{"country":"Hungary","full_name":"SYNLAB Hungary Kft.","duties_or_roles":"LAB LOGISTICS AND ANALYSIS","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Central Medical Reading or Imaging Reading","organisation_type":"Pharmaceutical company"}
{"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"LAB LOGISTICS AND ANALYSIS","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"LAB LOGISTICS AND ANALYSIS","organisation_type":"Pharmaceutical company"}
{"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
{"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"Hungary","full_name":"Somogy Varmegyei Kaposi Mor Oktato Korhaz","duties_or_roles":"Imaging management","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
{"country":"Hungary","full_name":"Affidea Magyarorszag Kft.","duties_or_roles":"Imaging management","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"Hungary","full_name":"Medicopus Nonprofit Kft.","duties_or_roles":"Imaging management","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"LAB LOGISTICS AND ANALYSIS","organisation_type":"Pharmaceutical company"}
{"country":"Hungary","full_name":"Orszagos Verellato Szolgalat","duties_or_roles":"LAB LOGISTICS AND ANALYSIS","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"Hungary","full_name":"Semmelweis Egyetem","duties_or_roles":"LAB LOGISTICS AND ANALYSIS","organisation_type":"Educational Institution"}
{"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"LAB LOGISTICS AND ANALYSIS","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
{"country":"Belgium","full_name":"CellCarta Biosciences","duties_or_roles":"LAB LOGISTICS AND ANALYSIS","organisation_type":"Pharmaceutical company"}
{"country":"Hungary","full_name":"Scanomed Kft.","duties_or_roles":"Imaging management","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"Imaging management","organisation_type":"Pharmaceutical company"}
{"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
{"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: Isatuximab
Active Substance: ISATUXIMAB
Modality: Monoclonal antibody
Routes Of Administration: INTRAVENOUS USE
Route: INTRAVENOUS
Authorisation Status: prodAuthStatus=1
Maximum Dose: 10 mg/kg

Investigational Product Name: Lenalidomide (Zelvina / Revlimid formulations)
Active Substance: LENALIDOMIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL
Authorisation Status: prodAuthStatus=2 (various MA numbers listed)
Maximum Dose: 25 mg

Investigational Product Name: Dexamethasone (various formulations listed)
Active Substance: DEXAMETHASONE / DEXAMETHASONE SODIUM PHOSPHATE
Modality: Small molecule
Routes Of Administration: ORAL USE / INTRAVENOUS USE (formulation dependent)
Route: ORAL / INTRAVENOUS
Authorisation Status: prodAuthStatus=2 (various MA numbers listed)
Maximum Dose: 40 mg

Combination Treatment: Yes

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