Clinical trial • Phase III • Oncology|Haematology

TECLISTAMAB for Newly diagnosed multiple myeloma | Multiple myeloma

Phase III trial of TECLISTAMAB for Newly diagnosed multiple myeloma | Multiple myeloma.

Overview

Trial Therapeutic Area: Oncology|Haematology
Trial Disease: Newly diagnosed multiple myeloma | Multiple myeloma
Trial Stage: Phase III
Drug Modality: Bispecific antibody|Small molecule

Key dates

Initial CTIS Submission Date: 17-05-2024
First CTIS Authorization Date: 02-07-2024

Trial design

Randomised, open-label, arm a: teclistamab in combination with lenalidomide (tec-len) — teclistamab (subcutaneous) + lenalidomide (oral capsules); arm b: lenalidomide alone (oral capsules); arm c: teclistamab alone (subcutaneous). doses and schedules: as per protocol (not specified in ctis summary).-controlled, adaptive Phase III trial in Poland, Denmark, Austria and others.

Randomised: Yes
Open Label: Yes
Comparator: Arm A: Teclistamab in combination with lenalidomide (Tec-Len) — teclistamab (subcutaneous) + lenalidomide (oral capsules); Arm B: Lenalidomide alone (oral capsules); Arm C: Teclistamab alone (subcutaneous). Doses and schedules: as per protocol (not specified in CTIS summary).
Adaptive: True, includes safety run-ins (SRI1 and SRI2) before randomized portion; SRI2 included cohorts and a Q4W teclistamab dosing modification from Cycle 2 based on emerging data; safety evaluations performed by IDMC and Joint Steering Committee to inform proceeding to randomized portion.
Target Sample Size: 487
Trial Duration For Participant: 730

Eligibility

Recruits 487 Vulnerable population selected (isVulnerablePopulationSelected=true). Informed consent requirement: "15.1 Must sign an informed consent form (ICF) (in accordance with the local requirements) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study." Participants must be ≥18 years old (see inclusion 1.2)..

Pregnancy Exclusion: 14.1 Participant is pregnant or breast-feeding or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study drug
Vulnerable Population: Vulnerable population selected (isVulnerablePopulationSelected=true). Informed consent requirement: "15.1 Must sign an informed consent form (ICF) (in accordance with the local requirements) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study." Participants must be ≥18 years old (see inclusion 1.2).

Inclusion criteria

{"criterion_text":"- 1.2 ≥18 years of age (and the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.\n- 10.2 A woman must be: a)Not of childbearing potential, or b)Of childbearing potential practicing 2 reliable methods of contraception simultaneously including one highly effective method of contraception and one other effective method of contraception starting 4 weeks prior to dosing, throughout the study including during dose interruptions and for a minimum of 4 weeks after the last dose of lenalidomide or for a minimum of 6 months after the last dose of teclistamab, whichever occurs later. For participants who are of childbearing potential, see Section 6.11.3 for details regarding concomitant use of estrogen containing products and lenalidomide.\n- 11.1 A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for a minimum of 6 months after the last dose of teclistamab, whichever occurs later.\n- 12.2 A man must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for a minimum of 3 months after the last dose of teclistamab, whichever occurs later. If his female partner is of childbearing potential, the male participant must use condom (with or without spermicide) and the female partner of the male participant must also be practicing a highly effective method of contraception\n- 13.2 A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for a minimum of 3 months after receiving the last dose of teclistamab, whichever occurs later\n- 14 Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n- 15.1 Must sign an informed consent form (ICF) (in accordance with the local requirements) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n- 2.3 Must have a new diagnosis of symptomatic MM according to IMWG criteria and have received 4 to 6 cycles of 3 or 4 drug-induction therapy that includes a proteasome inhibitor and/or an IMiD with or without anti-CD38 monoclonal antibody and a single or tandem ASCT. Post ASCT consolidation is permitted for up to 2 cycles as long as the total number of induction plus consolidation cycles does not exceed 6. Participants must complete all previous treatment prior to screening and at least 7 days prior to randomization (C1D1 for the safety run-in) except for cytotoxic therapy, which must be completed at least 21 days prior to randomization (C1D1 for the safety run-in).. SPEP from the time of diagnosis or prior to start of induction is required.\n- 3.2 Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria based on the investigator's assessment. Participants with plasmacytomas at the time of diagnosis must meet IMWG 2016 response criteria . for ≥PR based on repeat imaging utilizing the same modality (Kumar 2016).\n- 4 Must not be intolerant to the starting dose of lenalidomide.\n- 5.3 Must have received high-dose chemotherapy and first ASCT within 12 months of the start of induction therapy and be within 6 months of the last ASCT (7 months for participants who received consolidation) at the time of randomization or at the time of Sponsor approval for participants in safety run-in.\n- 6 Must not have received any maintenance therapy.\n- 7.1 Have an ECOG performance status score of 0-2 at screening and immediately prior to the start of administration of study treatment.\n- 8.1 Have clinical laboratory values meeting the following criteria (see the protocol).\n- 9.1 A woman of childbearing potential must have a negative serum pregnancy test within 10-14 days prior to the start of study treatment and again either a serum or urine pregnancy test within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study."}

Exclusion criteria

{"criterion_text":"- Criterion 1 was deleted\n- 10.2 Plasma cell leukemia, smoldering multiple myeloma, Waldenström's macroglobulinemia, POEMS syndrome or light chain amyloidosis in the absence of underlying symptomatic myeloma as defined per IMWG criteria with the presence of CRAB and/or SLiM symptoms.\n- 11 Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n- 12.1 Stroke, transient ischemic attack, or seizure within 6 months of C1D1\n- 13 Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients\n- 14.1 Participant is pregnant or breast-feeding or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study drug\n- 15.1 Participant plans to father a child while enrolled in this study or within 3 months after the last dose of study drug\n- 16.2 Presence of the following conditions: a)New York Heart Association stage III or IV congestive heart failure b)Myocardial infarction, unstable angina, or coronary artery bypass graft ≤6 months prior to C1D1 c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities\n- 17.1 Any of the following: a. HIV-positive participants with 1 or more of the following -History of AIDS-defining conditions -CD4 count <350 cells/mm3 at screening -Detectable viral load during screening or within six months prior to screening -Not receiving highly active ART -Had a change in antiretroviral therapy within 6 months of the start of screening -Receiving antiretroviral therapy that may interfere with study treatment as assessed after discussion with the Medical Monitor\n- 18.1 Hepatitis B infection: In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status\n- 19.1 Active hepatitis C infection as measured by detectable HCV- RNA Testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic HCV infection completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study\n- 2.1 Any previous therapy with a gene modified adoptive cell therapy\n- 20.3 Concurrent medical or psychiatric condition or disease, that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study\n- 21.1 Participant had major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or has not fully recovered from an earlier surgery, or has major surgery planned during the time the participant is expected to participate in the study or within 2 weeks after administration of the last dose of study treatment\n- 22.1 Have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks or 5 PK half-lives, whichever is longer, before C1D1 or is currently enrolled in an interventional investigational study except if only long term survival data is collected and after Sponsor approval is obtained\n- 3 Discontinued treatment due to any AE related to lenalidomide as determined by the investigator\n- 4.1 History of allogeneic stem cell transplantation or prior organ transplant\n- 5.1 Progressive disease as per IMWG 2016 response criteria at any time prior to randomization or C1D1 for participants in the safety run in\n- 6.1 Radiotherapy within 14 days or focal radiation within 7 days of C1D1\n- 7.2 Received a cumulative dose of corticosteroids equivalent to > 40 mg of dexamethasone within the 14 days prior to C1D1\n- 8.2 Received a live, attenuated vaccine within 4 weeks before C1D1. Non-live or non-replicating vaccines for emergency use are allowed\n- 9.3 Excluded for any of the following a) Any ongoing myelodysplastic syndrome or B cell malignancy (other than MM) b) Any history of malignancy, other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy c) Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured 1) Non-muscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, <3  cm, no CIS) 2) Non-melanoma skin cancers treated with curative therapy melanoma or localized melanoma treated with curative surgical resection alone 3) Non-invasive cervical cancer 4) Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer 5) Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only 6) Other malignancy that is considered cured with minimal risk of recurrence in consultation with the Sponsor's medical monitor"}

Endpoints

Primary endpoints

{"endpoint_text":"- PFS (per IRC) and 12-month MRD-negative CR (per IRC) are the dual primary endpoints for the study.","definition_or_measurement_approach":"PFS assessed per Independent Review Committee (IRC); 12-month MRD-negative CR assessed per IRC (MRD-negative CR definitions and NGF sensitivity described in secondary endpoint definitions)."}

Secondary endpoints

{"endpoint_text":"- OS is defined as the time from the date of randomization to the date of the participant’s death due to any cause.","definition_or_measurement_approach":"Defined as time from randomization to death from any cause."}
{"endpoint_text":"- CR or better (sCR+CR) is defined as participants who achieve a CR or better response per IMWG criteria.","definition_or_measurement_approach":"Assessed per IMWG response criteria."}
{"endpoint_text":"- CR conversion is defined as participants who were not in CR or better at the time of randomization but later went on to achieve CR or better prior to progressive disease or subsequent therapy, whichever is earlier.","definition_or_measurement_approach":"Conversion to CR prior to progression or subsequent therapy as assessed per IMWG criteria."}
{"endpoint_text":"- MRD-negative CR is defined as participants who achieve CR or better and MRD-negative status, as determined by NGF with sensitivity of 10-5, prior to progressive disease or subsequent therapy, whichever is earlier.","definition_or_measurement_approach":"MRD assessed by Next Generation Flow (NGF) with sensitivity 10^-5; must be prior to progression or subsequent therapy."}
{"endpoint_text":"- MRD-negative conversion is defined as participants who have not achieved MRD-negative status at the time of randomization and who later achieved MRD-negative, prior to progressive disease or subsequent therapy, whichever is earlier.","definition_or_measurement_approach":"Conversion to MRD-negative status prior to progression or subsequent therapy, assessed by NGF."}
{"endpoint_text":"- Sustained MRD-negative CR is defined as participants who achieve MRD-negative CR, confirmed minimum 1 year apart and without any examination showing MRD-positive status in between.","definition_or_measurement_approach":"MRD-negative CR confirmed at least 1 year apart with no intervening MRD-positive result."}
{"endpoint_text":"- PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Those who are alive and for whom a second disease progression has not been observed will be censored at the last date of follow-up.","definition_or_measurement_approach":"Time from randomization to progression on first subsequent antimyeloma therapy or death; censor at last follow-up if second progression not observed."}
{"endpoint_text":"- TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. Death due to progressive disease without start of subsequent therapy will be considered as event. Participants who withdrew full consent to study or are lost to follow-up, or die due to causes other than disease progression will be censored at the date of death or the last date known to be alive.","definition_or_measurement_approach":"Time from randomization to start of next antimyeloma therapy; death due to progression counts as event; censoring rules as stated."}
{"endpoint_text":"- Incidence and severity of AEs","definition_or_measurement_approach":"Adverse events collected and graded (incidence and severity)."}
{"endpoint_text":"- The PK of teclistamab.","definition_or_measurement_approach":"Pharmacokinetic sampling and analysis of teclistamab."}
{"endpoint_text":"- Presence and activity of ADAs to teclistamab","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADAs) presence and activity to teclistamab."}
{"endpoint_text":"- Time to worsening in overall HRQoL, symptoms, and functioning Change from baseline in overall HRQoL, symptoms, and functioning","definition_or_measurement_approach":"Patient-reported outcomes (HRQoL, symptoms, functioning) measured and changes/time-to-worsening assessed (instruments described in patient-facing documents)."}

Recruitment

Planned Sample Size: 487
Recruitment Window Months: 110
Consent Approach: Participants must sign an informed consent form (ICF) in accordance with local requirements ("15.1 Must sign an informed consent form (ICF) (in accordance with the local requirements) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study."). Participants are adults (≥18 years). ICF / patient information documents are provided in multiple languages (examples in CTIS documents: EN, DE, FR, IT, NL, PL, PT, EL, DA, NO, CS) and include main ICF, PP-PS versions and optional future research/re-consent materials as per country-specific documentation.

Geography

Total Number Of Sites: 98
Total Number Of Participants: 1127

Poland

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 05-07-2024
Processing Time Days: 28
Number Of Sites: 3
Number Of Participants: 20

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 Wróbel
Contact Person Email: tomasz-wrobel@wp.pl

Site Name: Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name: Oddzial Hematologii i Transplantacji Szpiku
Contact Person Name: Dominik Dytfeld
Contact Person Email: dytfeld@me.com

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

Denmark

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 02-07-2024
Processing Time Days: 25
Number Of Sites: 4
Number Of Participants: 60

Sites

Site Name: Aarhus Universitetshospital
Department Name: Department of Hematology
Contact Person Name: Maja Ølholm Vase
Contact Person Email: majavase@rm.dk

Site Name: Lillebaelt Hospital
Department Name: Department of Hematology
Contact Person Name: Sarah Farmer
Contact Person Email: sarah.farmer1@rsyd.dk

Site Name: Odense University Hospital
Department Name: Department of Hematology
Contact Person Name: Jakub Krajcik
Contact Person Email: jakub.krejcik@rsyd.dk

Site Name: Rigshospitalet
Department Name: Department of Hematology
Contact Person Name: Agoston Gyula Szabo
Contact Person Email: agoston.gyula.szabo@regionh.dk

Austria

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 08-07-2024
Processing Time Days: 31
Number Of Sites: 8
Number Of Participants: 100

Sites

Site Name: Stadt Wien Wiener Gesundheitsverbund
Department Name: Zentrum für Onkologie und Hämatologie
Principal Investigator Name: Martin Schreder
Principal Investigator Email: martin.schreder@gesundheitsverbund.at
Contact Person Name: Martin Schreder
Contact Person Email: martin.schreder@gesundheitsverbund.at

Site Name: Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name: Universitätsklinik für Innere Medizin III
Principal Investigator Name: Thomas Melchardt
Principal Investigator Email: T.melchardt@salk.at
Contact Person Name: Thomas Melchardt
Contact Person Email: T.melchardt@salk.at

Site Name: Ordensklinikum Linz GmbH
Department Name: Hämatologie und Onkologie
Principal Investigator Name: Irene Strassl
Principal Investigator Email: irene.strassl@ordensklinikum.at
Contact Person Name: Irene Strassl
Contact Person Email: irene.strassl@ordensklinikum.at

Site Name: Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name: Internal Medicine II, Interne E
Principal Investigator Name: Bernd Lorenz Hartmann
Principal Investigator Email: bernd.hartman@lkhf.at
Contact Person Name: Bernd Lorenz Hartmann
Contact Person Email: bernd.hartman@lkhf.at

Site Name: Steiermaerkische Krankenanstalten Ges.m.b.H.
Department Name: Innere Medizin, Abteilung für Hämatologie und Onkologie
Principal Investigator Name: Thamer Sliwa
Principal Investigator Email: Thamer.Sliwa@kages.at
Contact Person Name: Thamer Sliwa
Contact Person Email: Thamer.Sliwa@kages.at

Site Name: Universitaetsklinikum Krems
Department Name: Molekulare Onkologie/Hämatologie
Principal Investigator Name: Klaus Podar
Principal Investigator Email: klaus.podar@krems.lknoe.at
Contact Person Name: Klaus Podar
Contact Person Email: klaus.podar@krems.lknoe.at

Site Name: Medizinische Universitaet Innsbruck
Department Name: Universitätsklinik für Innere Medizin V
Principal Investigator Name: Wolfgang Willenbacher
Principal Investigator Email: wolfgang.willenbacher@tirol-kliniken.at
Contact Person Name: Wolfgang Willenbacher
Contact Person Email: wolfgang.willenbacher@tirol-kliniken.at

Site Name: Kepler Universitaetsklinikum GmbH
Department Name: Klinik für Innere Medizin 3 Hämatologie und Onkologie
Principal Investigator Name: Clemens Schmitt
Principal Investigator Email: c.schmitt@kepleruniklinikum.at
Contact Person Name: Clemens Schmitt
Contact Person Email: c.schmitt@kepleruniklinikum.at

Ireland

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 02-07-2024
Processing Time Days: 25
Number Of Sites: 7
Number Of Participants: 60

Sites

Site Name: St James's Hospital
Department Name: Department of Haematology
Principal Investigator Name: Patrick Hayden
Principal Investigator Email: phayden@stjames.ie
Contact Person Name: Patrick Hayden
Contact Person Email: phayden@stjames.ie

Site Name: Sligo University Hospital
Department Name: Haematology Department
Principal Investigator Name: Janusz Krawczyk
Principal Investigator Email: janusz.krawczyk@universityofgalway.ie
Contact Person Name: Janusz Krawczyk
Contact Person Email: janusz.krawczyk@universityofgalway.ie

Site Name: Cork University Hospital
Department Name: Haematology Department
Principal Investigator Name: Vitaliy Mykytiv
Principal Investigator Email: vitaliy.mykytiv@hse.ie
Contact Person Name: Vitaliy Mykytiv
Contact Person Email: vitaliy.mykytiv@hse.ie

Site Name: St Vincent's University Hospital
Department Name: Department of Haematology
Principal Investigator Name: Mark Coyne
Principal Investigator Email: markcoyne@svhg.ie
Contact Person Name: Mark Coyne
Contact Person Email: markcoyne@svhg.ie

Site Name: University Hospital Galway
Department Name: Haematology Department
Principal Investigator Name: Janusz Krawczyk
Principal Investigator Email: janusz.krawczyk@universityofgalway.ie
Contact Person Name: Janusz Krawczyk
Contact Person Email: janusz.krawczyk@universityofgalway.ie

Site Name: Beaumont Hospital
Department Name: Department of Haematology
Principal Investigator Name: John Quinn
Principal Investigator Email: johnquinn@beaumont.ie
Contact Person Name: John Quinn
Contact Person Email: johnquinn@beaumont.ie

Site Name: University Hospital Limerick
Department Name: Haematology Service
Principal Investigator Name: Ruth Clifford
Principal Investigator Email: ruth.clifford1@hse.ie
Contact Person Name: Ruth Clifford
Contact Person Email: ruth.clifford1@hse.ie

Greece

Earliest CTIS Part Ii Submission Date: 06-08-2024
Latest Decision Or Authorization Date: 09-09-2024
Processing Time Days: 34
Number Of Sites: 4
Number Of Participants: 80

Sites

Site Name: Evaggelismos Hospital
Department Name: Department of Haematology and Lymphomas, Bone Marrow Transplation Unit
Principal Investigator Name: Sosana Delimpasi
Principal Investigator Email: sodeli@yahoo.com
Contact Person Name: Sosana Delimpasi
Contact Person Email: sodeli@yahoo.com

Site Name: University General Hospital Of Alexandroupoli
Department Name: University Hematology Clinic
Principal Investigator Name: Emmanouil Spanoudakis
Principal Investigator Email: emmanouilspanoudakis@yahoo.com
Contact Person Name: Emmanouil Spanoudakis
Contact Person Email: emmanouilspanoudakis@yahoo.com

Site Name: Alexandra Hospital
Department Name: Deptartment of Clinical Therapeutics
Principal Investigator Name: Evangelos Terpos
Principal Investigator Email: eterpos@hotmail.com
Contact Person Name: Evangelos Terpos
Contact Person Email: eterpos@hotmail.com

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

Norway

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 02-07-2024
Processing Time Days: 25
Number Of Sites: 2
Number Of Participants: 30

Sites

Site Name: St. Olavs Hospital HF
Department Name: Department of Hematology
Principal Investigator Name: Tobias Schmidt Slordahl
Principal Investigator Email: tobias.s.slordahl@ntnu.no
Contact Person Name: Tobias Schmidt Slordahl
Contact Person Email: tobias.s.slordahl@ntnu.no

Site Name: Oslo University Hospital HF
Department Name: Oslo myelomatosesenter
Principal Investigator Name: Fredrik Schjesvold
Principal Investigator Email: fredrikschjesvold@gmail.com
Contact Person Name: Fredrik Schjesvold
Contact Person Email: fredrikschjesvold@gmail.com

France

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 05-07-2024
Processing Time Days: 28
Number Of Sites: 9
Number Of Participants: 100

Sites

Site Name: Centre Hospitalier Universitaire De Montpellier
Department Name: Department of Clinical Hematology
Principal Investigator Name: Laure Vincent
Principal Investigator Email: l-vincent@chu-montpellier.fr
Contact Person Name: Laure Vincent
Contact Person Email: l-vincent@chu-montpellier.fr

Site Name: Centre Hospitalier Universitaire De Toulouse
Department Name: Department of Hematology
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: Institut Paoli Calmettes
Department Name: Department of Hematology
Principal Investigator Name: Jean Marc Schiano de Colella
Principal Investigator Email: schianojm@ipc.unicancer.fr
Contact Person Name: Jean Marc Schiano de Colella
Contact Person Email: schianojm@ipc.unicancer.fr

Site Name: Hopital Saint Louis
Department Name: Department of Immuno-Hematology
Principal Investigator Name: Bertrand Arnulf
Principal Investigator Email: bertrand.arnulf@aphp.fr
Contact Person Name: Bertrand Arnulf
Contact Person Email: bertrand.arnulf@aphp.fr

Site Name: Centre Hospitalier Universitaire De Nantes
Department Name: Department of Hematology
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

Site Name: Hopital Saint Antoine
Department Name: Department of Hematology
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 Bordeaux
Department Name: Department of Hematology and Cellular Therapy
Principal Investigator Name: Cyrille Hulin
Principal Investigator Email: cyrille.hulin@chu-bordeaux.fr
Contact Person Name: Cyrille Hulin
Contact Person Email: cyrille.hulin@chu-bordeaux.fr

Site Name: Centre Hospitalier Universitaire De Poitiers
Department Name: Department of Clinical Hematology
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 Lille
Department Name: Department of Hematology
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

Italy

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 08-07-2024
Processing Time Days: 31
Number Of Sites: 28
Number Of Participants: 275

Sites

Site Name: Azienda Ospedaliera-Universitaria Di Cosenza
Department Name: UOC Ematologia
Principal Investigator Name: Massimo Gentile
Principal Investigator Email: massimo.gentile@tiscali.it
Contact Person Name: Massimo Gentile
Contact Person Email: massimo.gentile@tiscali.it

Site Name: Azienda Unita Sanitaria Locale Della Romagna
Department Name: UO Ematologia
Principal Investigator Name: Patrizia Tosi
Principal Investigator Email: patrizia.tosi@auslromagna.it
Contact Person Name: Patrizia Tosi
Contact Person Email: patrizia.tosi@auslromagna.it

Site Name: Fondazione IRCCS Policlinico San Matteo
Department Name: UOC Ematologia 1
Principal Investigator Name: Silvia Mangiacavalli
Principal Investigator Email: silvia_mangiacavalli@hotmail.com
Contact Person Name: Silvia Mangiacavalli
Contact Person Email: silvia_mangiacavalli@hotmail.com

Site Name: Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name: UOC Ematologia
Principal Investigator Name: Salvatore Palmieri
Principal Investigator Email: salvatore.palmieri@aocardarelli.it
Contact Person Name: Salvatore Palmieri
Contact Person Email: salvatore.palmieri@aocardarelli.it

Site Name: Azienda Sanitaria Locale Al Di Alessandria
Department Name: S.C. Ematologia
Principal Investigator Name: Federico Monaco
Principal Investigator Email: federico.monaco@ospedale.al.it
Contact Person Name: Federico Monaco
Contact Person Email: federico.monaco@ospedale.al.it

Site Name: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Department Name: UOC Ematologia
Principal Investigator Name: Monica Galli
Principal Investigator Email: monicagalli@asst-pg23.it
Contact Person Name: Monica Galli
Contact Person Email: monicagalli@asst-pg23.it

Site Name: Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name: UOC di Ematologia e Trapianti di Midollo
Principal Investigator Name: Fabrizio Pane
Principal Investigator Email: fabrizio.pane@unina.it
Contact Person Name: Fabrizio Pane
Contact Person Email: fabrizio.pane@unina.it

Site Name: Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name: SDCU Ematologia
Principal Investigator Name: Gloria Margiotta Casaluci
Principal Investigator Email: gloria.margiotta@med.uniupo.it
Contact Person Name: Gloria Margiotta Casaluci
Contact Person Email: gloria.margiotta@med.uniupo.it

Site Name: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Department Name: 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

Site Name: ARNAS G. Brotzu
Department Name: SC Ematologia
Principal Investigator Name: Daniele Derudas
Principal Investigator Email: daniele.derudas@aob.it
Contact Person Name: Daniele Derudas
Contact Person Email: daniele.derudas@aob.it

Site Name: Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name: Oncoematologia e Mieloma Multiplo
Principal Investigator Name: Francesca Gay
Principal Investigator Email: francesca.gay@unito.it
Contact Person Name: Francesca Gay
Contact Person Email: francesca.gay@unito.it

Site Name: Azienda Sanitaria Universitaria Giuliano Isontina
Department Name: SC (UCO) Ematologia
Principal Investigator Name: Francesco Zaja
Principal Investigator Email: francesco.zaja@asugi.sanita.fvg.it
Contact Person Name: Francesco Zaja
Contact Person Email: francesco.zaja@asugi.sanita.fvg.it

Site Name: Azienda Sanitaria Universitaria Friuli Centrale
Department Name: SOC Clinica Ematologica
Principal Investigator Name: Francesca Patriarca
Principal Investigator Email: francesca.patriarca@asufc.sanita.fvg.it
Contact Person Name: Francesca Patriarca
Contact Person Email: francesca.patriarca@asufc.sanita.fvg.it

Site Name: University Hospitals Parma Medical Center
Department Name: Department of Hematology and Bone Marrow Transplant Centre
Principal Investigator Name: Nicola Giuliani
Principal Investigator Email: nicola.giuliani@unipr.it
Contact Person Name: Nicola Giuliani
Contact Person Email: nicola.giuliani@unipr.it

Site Name: IRCCS Ospedale Policlinico San Martino
Department Name: Ematologia
Principal Investigator Name: Sara Aquino
Principal Investigator Email: sara.aquino@hsanmartino.it
Contact Person Name: Sara Aquino
Contact Person Email: sara.aquino@hsanmartino.it

Site Name: Azienda Sanitaria Universitaria Di Pescara
Department Name: Ematologia Clinica
Principal Investigator Name: Carmine Liberatore
Principal Investigator Email: carmine.liberatore@asl.pe.it
Contact Person Name: Carmine Liberatore
Contact Person Email: carmine.liberatore@asl.pe.it

Site Name: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name: UOC Ematologia
Principal Investigator Name: Niccolo Bolli
Principal Investigator Email: niccolo.bolli@policlinico.mi.it
Contact Person Name: Niccolo Bolli
Contact Person Email: niccolo.bolli@policlinico.mi.it

Site Name: Casa Sollievo Della Sofferenza
Department Name: UOC Ematologia
Principal Investigator Name: Antonietta Pia Falcone
Principal Investigator Email: a.falcone@operapadrepio.it
Contact Person Name: Antonietta Pia Falcone
Contact Person Email: a.falcone@operapadrepio.it

Site Name: Azienda Ospedaliera di Padova
Department Name: UOC Ematologia
Principal Investigator Name: Renato Zambello
Principal Investigator Email: r.zambello@unipd.it
Contact Person Name: Renato Zambello
Contact Person Email: r.zambello@unipd.it

Site Name: Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name: Ematologia
Principal Investigator Name: Elena Zamagni
Principal Investigator Email: e.zamagni@unibo.it
Contact Person Name: Elena Zamagni
Contact Person Email: e.zamagni@unibo.it

Site Name: Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name: Ematologia
Principal Investigator Name: Maurizio Martelli
Principal Investigator Email: principalinvestigatormartelli.dmtp@uniroma1.it
Contact Person Name: Maurizio Martelli
Contact Person Email: principalinvestigatormartelli.dmtp@uniroma1.it

Site Name: Azienda Unita Sanitaria Locale Della Romagna (Ravenna)
Department Name: Dipartimento di Oncologia ed Ematologia
Principal Investigator Name: Claudia Cellini
Principal Investigator Email: claudia.cellini@auslromagna.it
Contact Person Name: Claudia Cellini
Contact Person Email: claudia.cellini@auslromagna.it

Site Name: Careggi University Hospital
Department Name: SOD Ematologia
Principal Investigator Name: Elisabetta Antoniioli
Principal Investigator Email: antoniolie@aou-careggi.toscana.it
Contact Person Name: Elisabetta Antoniioli
Contact Person Email: antoniolie@aou-careggi.toscana.it

Site Name: Azienda Ospedaliero Universitaria Di Modena
Department Name: Dip.Scienze Mediche e Chirurgiche, Materno-Infantili e dell’Adulto -Univ. di Modena e Reggio Emilia
Principal Investigator Name: Mario Luppi
Principal Investigator Email: mario.luppi@unimore.it
Contact Person Name: Mario Luppi
Contact Person Email: mario.luppi@unimore.it

Site Name: Azienda USL IRCCS Di Reggio Emilia
Department Name: UO Ematologia
Principal Investigator Name: Barbara Gamberi
Principal Investigator Email: Barbara.Gamberi@ausl.re.it
Contact Person Name: Barbara Gamberi
Contact Person Email: Barbara.Gamberi@ausl.re.it

Site Name: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name: UOC Ematologia
Principal Investigator Name: Angelo Belotti
Principal Investigator Email: ange.belotti@gmail.com
Contact Person Name: Angelo Belotti
Contact Person Email: ange.belotti@gmail.com

Site Name: University Of Bari Aldo Moro (two sites listed)
Department Name: U.O.C. Medicina Interna Universitaria "G. Baccelli" / UO Ematologia con Trapianto
Principal Investigator Name: Roberto Ria / Pellegrino Musto
Principal Investigator Email: roberto.ria@uniba.it / Pellegrino.musto@uniba.it
Contact Person Name: Roberto Ria / Pellegrino Musto
Contact Person Email: roberto.ria@uniba.it / Pellegrino.musto@uniba.it

Germany

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 05-07-2024
Processing Time Days: 28
Number Of Sites: 8
Number Of Participants: 80

Sites

Site Name: Klinikum rechts der Isar der TU Muenchen AöR
Department Name: Innere Medizin III-Haematologie/Onkologie
Principal Investigator Name: Florian Bassermann
Principal Investigator Email: florian.bassermann@tum.de
Contact Person Name: Florian Bassermann
Contact Person Email: florian.bassermann@tum.de

Site Name: Universitaetsklinikum Tuebingen AöR
Department Name: Innere Medizin II - Hämatologie, Onkologie, klinische Immunologie und Rheumatologie
Principal Investigator Name: Britta Besemer
Principal Investigator Email: britta.besemer@med.uni-tuebingen.de
Contact Person Name: Britta Besemer
Contact Person Email: britta.besemer@med.uni-tuebingen.de

Site Name: Universitaetsklinikum Schleswig-Holstein AöR
Department Name: Klinik für Hämatologie und Onkologie
Principal Investigator Name: Cyrus Khandanpour
Principal Investigator Email: Cyrus.Khandanpour@uksh.de
Contact Person Name: Cyrus Khandanpour
Contact Person Email: Cyrus.Khandanpour@uksh.de

Site Name: Universitaetsklinikum Jena KöR
Department Name: Klinik für Innere Medizin II Abt. Hämatologie und Internistische Omkologie
Principal Investigator Name: Olaposi Yomade
Principal Investigator Email: olaposi.yomade@med.uni-jena.de
Contact Person Name: Olaposi Yomade
Contact Person Email: olaposi.yomade@med.uni-jena.de

Site Name: Universitaetsklinikum Heidelberg AöR
Department Name: Myeloma Center, Dept of Internal Medicine V, Hematology, Oncology and Rheumatology
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: Universitaetsklinikum Wuerzburg AöR
Department Name: Med. Klinik II, Hämatologie/Onkologie
Principal Investigator Name: Leo Rasche
Principal Investigator Email: Rasche_L@ukw.de
Contact Person Name: Leo Rasche
Contact Person Email: Rasche_L@ukw.de

Site Name: Klinikum Nuernberg
Department Name: Einheit fuer Knochenmarktransplantation
Principal Investigator Name: Knut Wendelin
Principal Investigator Email: Knut.Wendelin@klinikum-nuernberg.de
Contact Person Name: Knut Wendelin
Contact Person Email: Knut.Wendelin@klinikum-nuernberg.de

Site Name: University Medical Center Hamburg-Eppendorf
Department Name: Medizinische Klinik und Polikllinik Onkologie und Knochenmarktransplantation, Haematologie
Principal Investigator Name: Katja Weisel
Principal Investigator Email: k.weisel@uke.de
Contact Person Name: Katja Weisel
Contact Person Email: k.weisel@uke.de

Belgium

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 02-07-2024
Processing Time Days: 25
Number Of Sites: 5
Number Of Participants: 50

Sites

Site Name: CHU Helora
Department Name: Department of Hematology
Principal Investigator Name: Alain Kentos
Principal Investigator Email: alain.kentos@helora.be
Contact Person Name: Alain Kentos
Contact Person Email: alain.kentos@helora.be

Site Name: Algemeen Ziekenhuis Delta
Department Name: Department of Hematology
Principal Investigator Name: Lien Deleu
Principal Investigator Email: lien.deleu@azdelta.be
Contact Person Name: Lien Deleu
Contact Person Email: lien.deleu@azdelta.be

Site Name: Centre hospitalier universitaire de Liege
Department Name: Department of Hematology
Principal Investigator Name: Jo Caers
Principal Investigator Email: jo.caers@chuliege.be
Contact Person Name: Jo Caers
Contact Person Email: jo.caers@chuliege.be

Site Name: Jessa Ziekenhuis
Department Name: Department of Hematology
Principal Investigator Name: Koen Theunissen
Principal Investigator Email: koen.theunissen@jessazh.be
Contact Person Name: Koen Theunissen
Contact Person Email: koen.theunissen@jessazh.be

Site Name: UZ Leuven
Department Name: Department of 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

Czechia

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 04-07-2024
Processing Time Days: 27
Number Of Sites: 6
Number Of Participants: 100

Sites

Site Name: Fakultni Nemocnice Plzen
Department Name: Department of Hematology and Oncology
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 Hradec Kralove
Department Name: 4th Department of Internal Medicine
Principal Investigator Name: Jakub Radocha
Principal Investigator Email: RadochaJ@lfhk.cuni.cz
Contact Person Name: Jakub Radocha
Contact Person Email: RadochaJ@lfhk.cuni.cz

Site Name: University Hospital Olomouc
Department Name: Department of Haemato-Oncology
Principal Investigator Name: Jiří Minařík
Principal Investigator Email: abretina@email.cz
Contact Person Name: Jiří Minařík
Contact Person Email: abretina@email.cz

Site Name: Fakultni Nemocnice Ostrava
Department Name: Department of Haematooncology
Principal Investigator Name: Roman Hájek
Principal Investigator Email: roman.hajek@fno.cz
Contact Person Name: Roman Hájek
Contact Person Email: roman.hajek@fno.cz

Site Name: Fakultni Nemocnice Brno
Department Name: Internal Hematology and Oncology Clinic
Principal Investigator Name: Luděk Pour
Principal Investigator Email: pour.ludek@fnbrno.cz
Contact Person Name: Luděk Pour
Contact Person Email: pour.ludek@fnbrno.cz

Site Name: Vseobecna Fakultni Nemocnice V Praze
Department Name: Department of Internal Medicine - Hematology
Principal Investigator Name: Ivan Špička
Principal Investigator Email: spicka@cesnet.cz
Contact Person Name: Ivan Špička
Contact Person Email: spicka@cesnet.cz

Netherlands

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 03-07-2024
Processing Time Days: 26
Number Of Sites: 9
Number Of Participants: 120

Sites

Site Name: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name: Department of Hematology
Principal Investigator Name: Ruth Wester
Principal Investigator Email: r.wester@erasmusmc.nl
Contact Person Name: Ruth Wester
Contact Person Email: r.wester@erasmusmc.nl

Site Name: Universitair Medisch Centrum Groningen
Department Name: Department of Heamatology
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: Dijklander Ziekenhuis
Department Name: Interne Geneeskunde
Principal Investigator Name: Clara P.W. Klerk
Principal Investigator Email: c.p.w.klerk@dijklander.nl
Contact Person Name: Clara P.W. Klerk
Contact Person Email: c.p.w.klerk@dijklander.nl

Site Name: St. Antonius Ziekenhuis
Department Name: Interne Geneeskunde
Principal Investigator Name: Inger Nijhof
Principal Investigator Email: i.nijhof@antoniusziekenhuis.nl
Contact Person Name: Inger Nijhof
Contact Person Email: i.nijhof@antoniusziekenhuis.nl

Site Name: Noordwest Ziekenhuisgroep Stichting
Department Name: Interne geneeskunde
Principal Investigator Name: Matthijs Westerman
Principal Investigator Email: M.Westerman@nwz.nl
Contact Person Name: Matthijs Westerman
Contact Person Email: M.Westerman@nwz.nl

Site Name: Amsterdam UMC Stichting
Department Name: Department of Hematology
Principal Investigator Name: Niels Van der Donk
Principal Investigator Email: n.vandedonk@amsterdamumc.nl
Contact Person Name: Niels Van der Donk
Contact Person Email: n.vandedonk@amsterdamumc.nl

Site Name: Maxima Medisch Centrum
Department Name: Maxima Oncologisch Centrum
Principal Investigator Name: Laurens Nieuwenhuizen
Principal Investigator Email: Laurens.nieuwenhuizen@mmc.nl
Contact Person Name: Laurens Nieuwenhuizen
Contact Person Email: Laurens.nieuwenhuizen@mmc.nl

Site Name: Maasstad Ziekenhuis Stichting
Department Name: Interne Geneeskunde
Principal Investigator Name: Renier Sprenger
Principal Investigator Email: SpijkerH@maasstadziekenhuis.nl
Contact Person Name: Renier Sprenger
Contact Person Email: SpijkerH@maasstadziekenhuis.nl

Site Name: Albert Schweitzer Ziekenhuis
Department Name: Internal Medicine Department
Principal Investigator Name: Mark-David Levin
Principal Investigator Email: m-d.levin@asz.nl
Contact Person Name: Mark-David Levin
Contact Person Email: m-d.levin@asz.nl

Portugal

Earliest CTIS Part Ii Submission Date: 30-01-2025
Latest Decision Or Authorization Date: 10-04-2025
Processing Time Days: 70
Number Of Sites: 5
Number Of Participants: 52

Sites

Site Name: Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name: Serviço de Hematologia Clínica
Principal Investigator Name: Marta Gomes
Principal Investigator Email: marta.aguiar.gomes@ulsge.min-saude.pt
Contact Person Name: Marta Gomes
Contact Person Email: marta.aguiar.gomes@ulsge.min-saude.pt

Site Name: Champalimaud Clinical Centre
Department Name: Unidade de Hemato-oncologia
Principal Investigator Name: Cristina João
Principal Investigator Email: cristina.joao@fundacaochampalimaud.pt
Contact Person Name: Cristina João
Contact Person Email: cristina.joao@fundacaochampalimaud.pt

Site Name: Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Department Name: Hematologia Clínica
Principal Investigator Name: Patrícia Alexandra Morais Ferraz
Principal Investigator Email: geral@chtmad.min-saude.pt
Contact Person Name: Patrícia Alexandra Morais Ferraz
Contact Person Email: geral@chtmad.min-saude.pt

Site Name: Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name: Serviço de Onco-Hematologia
Principal Investigator Name: Mario Mariz
Principal Investigator Email: mariz@ipoporto.min-saude.pt
Contact Person Name: Mario Mariz
Contact Person Email: mariz@ipoporto.min-saude.pt

Site Name: Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name: Clinical Hematology Unit - Hematology Department
Principal Investigator Name: Paulo Bernardo
Principal Investigator Email: pbernardo@ipolisboa.min-saude.pt
Contact Person Name: Paulo Bernardo
Contact Person Email: pbernardo@ipolisboa.min-saude.pt

Sponsor

Primary sponsor

Full Name: European Myeloma Network B.V.
Organisation Type: Patient organisation/association
Country Of Registered Address: Netherlands

Contract research organisations

Name: Health Data Specialists Consulting Services Organization And Conduct Of Studies Single Member S.A.
Responsibilities: Contracts with the investigators & payments; operational study conduct responsibilities (codes include 1,12,15 and others as listed in CTIS)

Name: Health Data Specialists Ireland Limited
Responsibilities: Contracts with the investigators & payments; IVRS treatment randomisation; operational study functions

Name: Medidata Solutions Inc.
Responsibilities: Clinical trial technology/vendor services (code 7)

Third parties

{"country":"Netherlands","full_name":"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","duties_or_roles":"Immunophenotyping & molecular markers Circulating proteins","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"Italy","full_name":"Octapharma Italy S.p.A.","duties_or_roles":"Duties code 14 (per sponsor thirdParties entry)","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"Julius-Maximilians-Universitaet Wuerzburg","duties_or_roles":"Whole genome sequencing, metabololism analyses","organisation_type":"Educational Institution"}
{"country":"Greece","full_name":"Health Data Specialists Consulting Services Organization And Conduct Of Studies Single Member S.A.","duties_or_roles":"Contracts with the investigators & payments; multiple operational duties (codes 1,12,15 and others)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Duties code 7 (clinical trial technology/vendor responsibilities)","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"MRD-NGS","organisation_type":"Pharmaceutical company"}
{"country":"Netherlands","full_name":"Amsterdam UMC Stichting","duties_or_roles":"Phenotypic & molecular characterization of immune cells Circulating extracellular vesicles","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"United States","full_name":"Phenopath Laboratories PLLC","duties_or_roles":"biomarker analysis (soft tissue plasmacytoma biopsy)","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"China","full_name":"Frontage Laboratories (Shanghai) Co. Ltd.","duties_or_roles":"PK, Immunogenicity","organisation_type":"Pharmaceutical company"}
{"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"Efficacy assessments (serum &urine test), MRD-NGF","organisation_type":"Pharmaceutical company"}
{"country":"Denmark","full_name":"Cts Scandinavia ApS","duties_or_roles":"Duties code 1","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Efficacy assessments(serum &urine test), MRD-NGF","organisation_type":"Pharmaceutical company"}
{"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"Efficacy assessments(serum &urine test), MRD-NGF","organisation_type":"Pharmaceutical company"}
{"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"Packaging & Labelling, Distribution to the sites, receipt, storage and destruction","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Efficacy assessments (serum & urine test), MRD-NGF","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Janssen Research And Development LLC","duties_or_roles":"Maintenance of global Safety Database; Direct submission of teclistamab IMPD where this is requested; other sponsor support duties","organisation_type":"Pharmaceutical company"}
{"country":"Ireland","full_name":"Health Data Specialists Ireland Limited","duties_or_roles":"Contracts with the investigators & payments; IVRS – treatment randomisation; other operational duties","organisation_type":"Pharmaceutical company"}

Co-sponsors

Emn Trial Office S.r.l. Impresa Sociale

Investigational products

Investigational Product Name: teclistamab (SOLUTION FOR INJECTION, subcutaneous)
Active Substance: TECLISTAMAB
Modality: Bispecific antibody
Routes Of Administration: Subcutaneous use
Route: Subcutaneous
Authorisation Status: Investigational/IMP (no EU marketing authorisation in productDictionaryInfo)

Investigational Product Name: Lenalidomide (Lenalidomide Accord 2.5 mg / 5 mg / 10 mg / 15 mg hard capsules)
Active Substance: LENALIDOMIDE
Modality: Small molecule
Routes Of Administration: Oral
Route: Oral
Authorisation Status: Authorised (marketing authorisations listed in productDictionaryInfo EU/1/18/1316 ...)
Dose Levels: 2.5 mg; 5 mg; 10 mg; 15 mg (product strengths available)

Combination Treatment: Yes

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