Clinical trial • Phase III • Oncology

IBERDOMIDE for Relapsed or refractory multiple myeloma

Phase III trial of IBERDOMIDE for Relapsed or refractory multiple myeloma.

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Relapsed or refractory multiple myeloma
Trial Stage: Phase III
Drug Modality: Small molecule|Monoclonal antibody
Orphan Drug: Yes

Key dates

Initial CTIS Submission Date: 20-05-2024
First CTIS Authorization Date: 30-07-2024

Trial design

Randomised, open-label, treatment arm a (iberdomide, daratumumab and dexamethasone): oral iberdomide at 1, 1.3 or 1.6 mg once daily from days 1 to 21 of a 28-day cycle; daratumumab administered as 1800 mg subcutaneously; oral dexamethasone administered at a total dose of 40 mg weekly on days 1, 8, 15 and 22. | treatment arm b (daratumumab, bortezomib and dexamethasone): daratumumab 1800 mg subcutaneously; bortezomib subcutaneously at a starting dose of 1.3 mg/m2; oral dexamethasone starting dose 20 mg.-controlled, adaptive Phase III trial in Sweden, Norway, Czechia and others.

Randomised: Yes
Open Label: Yes
Comparator: Treatment Arm A (iberdomide, daratumumab and dexamethasone): Oral iberdomide at 1, 1.3 or 1.6 mg once daily from Days 1 to 21 of a 28-day cycle; Daratumumab administered as 1800 mg subcutaneously; Oral dexamethasone administered at a total dose of 40 mg weekly on Days 1, 8, 15 and 22. | Treatment Arm B (daratumumab, bortezomib and dexamethasone): Daratumumab 1800 mg subcutaneously; Bortezomib subcutaneously at a starting dose of 1.3 mg/m2; Oral dexamethasone starting dose 20 mg.
Adaptive: True, two-stage design with Stage 1 dose-finding to determine the recommended iberdomide dose (safety, PK, PD and preliminary efficacy inform dose selection for Stage 2); PK assessments and dose selection rules applied in Stage 1.
Single Multiple Or Escalation Dose Combined: Yes
Target Sample Size: 470

Eligibility

Recruits 470 Excludes vulnerable individuals: 'Vulnerable, under judicial protection, people without freedom by administrative or judicial decision, people with psychiatric conditions without their consent, people accepted in a health or social institution for other purposes than the research, adults under legal guardianship, curatorship, and people incapable of giving consent personally.' Subjects must understand and voluntarily sign an ICF prior to any study-related assessments/procedures; only adults (≥18) may consent..

Pregnancy Exclusion: 21.Subject is an individual of childbearing potential who is pregnant, nursing or breastfeeding, or who intends to become pregnant during participation in the study.
Vulnerable Population: Excludes vulnerable individuals: 'Vulnerable, under judicial protection, people without freedom by administrative or judicial decision, people with psychiatric conditions without their consent, people accepted in a health or social institution for other purposes than the research, adults under legal guardianship, curatorship, and people incapable of giving consent personally.' Subjects must understand and voluntarily sign an ICF prior to any study-related assessments/procedures; only adults (≥18) may consent.

Inclusion criteria

{"criterion_text":"- 1.Subject is ≥ 18 years of age at the time of signing the ICF.\n- 2.Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.\n- 3.Subject is willing and able to adhere to the study visit schedule and other protocol requirements.\n- 4.Subject has documented diagnosis of MM and measurable disease, defined as any of the following: a.M-protein quantities ≥ 1 g/dL by sPEP or ≥ 200 mg/24-hour urine collection by uPEP; or b.Light chain MM without measurable disease in serum or urine: serum FLC levels ≥ 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio\n- 5.Subject has received one to 2 prior lines of anti-myeloma therapy.\n- 6.Subject achieved a response (PR or better) to at least 1 prior anti-myeloma regimen.\n- 7.Subject must have documented disease progression during or after their last anti-myeloma regimen.\n- 8.Prior treatment with CD38-directed therapy: In Stage 1, subjects with prior CD38-directed- containing therapy are not eligible. In Stage 2, prior treatment with CD38-directed therapy is permitted only if all the following are fulfilled: a. Best response achieved during CD38-directed-containing therapy was ≥ PR. b.Subject did not progress while receiving CD38-directed therapy or within 60 days of last dose of therapy. c.Subject did not discontinue CD38-directed therapy due to a related AE. d.Last dose of daratumumab was ≥ 3 months prior to randomization.\n- 9.Prior treatment with bortezomib therapy is permitted, if all the following are fulfilled: a.Best response achieved during bortezomib- containing therapy was at least a minimal response (MR). b.Subject did not progress while receiving bortezomib therapy or within 60 days of last dose of therapy.\n- 10.Subject has an ECOG performance status score of 0, 1 or 2.\n- 11.Individuals of childbearing potential (IOCBP) must: a.Have two negative pregnancy tests as verified by the Investigator prior to starting study treatment. They must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact. b.Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, 2 forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting study treatment, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of iberdomide, 3 months after the last dose of daratumumab or 7 months after the last dose of bortezomib, whichever is longest.\n- 12.Individuals assigned male at birth must: a. Practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to use a condom during sexual contact with a pregnant partner or an individual of childbearing potential while participating in the study, during dose interruptions and for at least 28 days after the last dose of iberdomide, 3 months after the last dose of daratumumab, or 4 months after the last dose of bortezomib, whichever is longer even if he has undergone a successful vasectomy. Contraception requirements are detailed in APPENDIX E and local PI of bortezomib and daratumumab\n- 13.Male (as assigned at birth) subjects must agree to refrain from donating sperm while receiving iberdomide, during dose interruptions and for at least 28 days following the last dose of iberdomide, 3 months after the last dose of daratumumab or 4 months after the last dose of bortezomib whichever is later.\n- 14.Subjects must agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment.\n- 15.All subjects must follow all requirements defined in the Pregnancy Prevention Program (v8.0). See APPENDIX E and local PI of bortezomib and daratumumab (see current version of PI, SmPC, or equivalent document for the specific country/region)."}

Exclusion criteria

{"criterion_text":"- 1.Subject has any significant medical condition\n- 2. Coronavirus Disease 2019 (COVID-19) within 7 days for mild or asymptomatic infections or 14 days for moderate/severe infections prior to initiating study treatment. A longer duration may be needed based on the investigator’s clinical judgment.\n- 3.Subject has any condition that confounds the ability to interpret data from the study.\n- 4.Subject has any of the following laboratory abnormalities: a.ANC <1,000 cells/µL. It is not permissible to administer GCSF to achieve minimum ANC levels. b. Platelet count: < 50,000 cells/µL. It is not permissible to transfuse subjects to achieve minimum platelet counts c.Hemoglobin <8 g/dL (<4.9 mmol/L) d.eGFR <30 mL/min or requiring dialysis. e.Corrected serum calcium >13.5 mg/dL (>3.4 mmol/L). f.Serum AST or ALT >2.5 × ULN g.Serum total bilirubin >1.5 × ULN or >3.0 mg/dL for subjects with documented Gilbert's syndrome.\n- 5.Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome, or clinically significant amyloidosis\n- 6.Subject has peripheral neuropathy Grade 3, 4 or 2 with pain.\n- 7.Subject has gastrointestinal disease that may significantly alter the absorption of iberdomide and/or other oral study treatment.\n- 8.Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥3 years with the exception of some noninvasive malignancies.\n- 9.Subject with known central nervous system involvement with MM.\n- 10.Subject has received immunosuppressive medication within the last 14 days of initiating study treatment .\n- 11.Subject has impaired cardiac function or clinically significant cardiac disease.\n- 12.Subject received prior therapy with iberdomide.\n- 13.Subject received any of the following a.Plasmapheresis within the last 28 days of initialting study treatment b.Major surgery within 28 days of initialting study treatment c.Radiation therapy, other than local palliative therapy, for myeloma associated bone lesions within 14 days of initialting study treatment d.Use of any systemic anti-myeloma drug therapy within 14 days of initialting study treatment\n- 14.Subject received any investigational agent within 28 days.\n- 15.Subject has previously received a live vaccine within 3 months of of initialting study treatment.\n- 16.Concurrent administration of a strong inhibitor or inducer of CYP450 (including within 14 days of initialting study treatment).\n- 17.Subject is unable or unwilling to undergo protocol required thromboembolism or herpes zoster prophylaxis.\n- 18.Subject has previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of initialting study treatment.\n- 19.Subject has known COPD with a FEV1 <50% of predicted normal.\n- 20.Subject has known moderate or severe persistent asthma within the last 2 years, or currently has uncontrolled asthma of any classification.\n- 21.Subject is an individual of childbearing potential who is pregnant, nursing or breastfeeding, or who intends to become pregnant during participation in the study.\n- 22.Subject is positive for human immunodeficiency virus, chronic or active hepatitis B, A or C.\n- 23.Subject has prior history of systemic or clinically significant allergies, hypersensitivity, or intolerance to boron or mannitol, hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies or human proteins, cereblon modulating agents or their excipients or known sensitivity to mammalian-derived products.\n- 24.Subject has any contraindications to daratumumab, bortezomib or dexamethasone, per local PI.\n- 25.Vulnerable, under judicial protection, people without freedom by administrative or judicial decision, people with psychiatric conditions without their consent, people accepted in a health or social institution for other purposes than the research, adults under legal guardianship, curatorship, and people incapable of giving consent personally."}

Endpoints

Primary endpoints

{"endpoint_text":"- Progression-free survival (PFS): Time from randomization to the first documentation of progressive disease according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma 2016 or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"Time from randomization to first documented progressive disease per IMWG Uniform Response Criteria for Multiple Myeloma (2016) or death from any cause."}
{"endpoint_text":"- Minimal Residual Disease (MRD) negative CR at any time: Achievement of MRD negativity defined as less than 1 in 10^5 nucleated cells (by next generation flow cytometry) in bone marrow aspirate for subjects who achieve CR or better at any time after randomization","definition_or_measurement_approach":"MRD negativity defined as <1 in 10^5 nucleated cells by next generation flow cytometry on bone marrow aspirate in subjects achieving CR or better after randomization."}

Secondary endpoints

{"endpoint_text":"- Recommended iberdomide dose for Stage 2, based on the totality of safety, efficacy, PK and PD data","definition_or_measurement_approach":""}
{"endpoint_text":"- In Stage 1, PK of iberdomide","definition_or_measurement_approach":"Pharmacokinetic assessments of iberdomide in Stage 1 per protocol PK sampling schedule."}
{"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
{"endpoint_text":"- Sustainability of MRD negativity","definition_or_measurement_approach":""}
{"endpoint_text":"- Overall response","definition_or_measurement_approach":""}
{"endpoint_text":"- Time to response","definition_or_measurement_approach":""}
{"endpoint_text":"- Duration of response","definition_or_measurement_approach":""}
{"endpoint_text":"- Time to progression","definition_or_measurement_approach":""}
{"endpoint_text":"- Time to next treatment","definition_or_measurement_approach":""}
{"endpoint_text":"- Progression-free survival 2","definition_or_measurement_approach":""}
{"endpoint_text":"- Safety","definition_or_measurement_approach":""}
{"endpoint_text":"- EORTC QLQ-C30 and EORTC QLQ-MY20","definition_or_measurement_approach":"Health-related quality of life assessed using EORTC QLQ-C30 and EORTC QLQ-MY20 questionnaires."}

Recruitment

Planned Sample Size: 470
Recruitment Window Months: 87
Consent Approach: Subjects must understand and voluntarily sign an ICF prior to any study-related assessments/procedures. Only adults (≥18 years) may consent. Country-specific ICFs and related documents are provided (Main ICF, Pregnant Subject ICF, Pregnant Partner ICF, Optional Research ICF, addenda) in multiple languages per site (examples in the public documents: Swedish, Norwegian, Czech, Polish, French, Greek, Portuguese, German, Spanish, Italian, Dutch, Finnish, English). Vulnerable individuals who cannot provide personal consent are excluded.

Geography

Total Number Of Sites: 77
Total Number Of Participants: 394

Sweden

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 24-03-2025
Processing Time Days: 286
Number Of Sites: 2
Number Of Participants: 12

Sites

Site Name: Sodra Alvsborg Hospital-Vastra Gotalandsregionen
Department Name: Medicinmottagningen, Södra Älvsborgs Sjukhus Borås
Principal Investigator Name: Ulf Henrik Mellqvist
Principal Investigator Email: ulf-henrik.mellqvist@vgregion.se
Contact Person Name: Ulf Henrik Mellqvist
Contact Person Email: ulf-henrik.mellqvist@vgregion.se

Site Name: Region Skane Helsingborg Hospital
Department Name: Hematologimottagningen, Helsingborgs lasarett
Principal Investigator Name: Per Axelsson
Principal Investigator Email: Per.Axelsson@skane.se
Contact Person Name: Per Axelsson
Contact Person Email: Per.Axelsson@skane.se

Norway

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 23-04-2026
Processing Time Days: 681
Number Of Sites: 3
Number Of Participants: 8

Sites

Site Name: St. Olavs Hospital HF
Department Name: Department for Blood diseases
Principal Investigator Name: Tobias Slørdahl
Principal Investigator Email: tobias.s.slordahl@ntnu.no
Contact Person Name: Tobias Slørdahl
Contact Person Email: tobias.s.slordahl@ntnu.no

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

Site Name: Helse Bergen HF
Department Name: Department of infectious diseases
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

Czechia

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 24-04-2026
Processing Time Days: 682
Number Of Sites: 3
Number Of Participants: 10

Sites

Site Name: Vseobecna Fakultni Nemocnice V Praze
Department Name: I.Interní klinika-klinika hematologie
Principal Investigator Name: Ivan Špička
Principal Investigator Email: spicka@cesnet.cz
Contact Person Name: Ivan Špička
Contact Person Email: spicka@cesnet.cz

Site Name: Fakultni Nemocnice Ostrava
Department Name: Klinika hematoonkologie
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: Interní hematologická a onkologická klinika
Principal Investigator Name: Luděk Pour
Principal Investigator Email: pour.ludek@fnbrno.cz
Contact Person Name: Luděk Pour
Contact Person Email: pour.ludek@fnbrno.cz

Poland

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 24-04-2026
Processing Time Days: 682
Number Of Sites: 6
Number Of Participants: 28

Sites

Site Name: Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name: Klinika Hematologii z Pododdziałem Chorób Naczyń
Principal Investigator Name: Jarosław Piszcz
Principal Investigator Email: jaroslaw.piszcz@gmail.com
Contact Person Name: Jarosław Piszcz
Contact Person Email: jaroslaw.piszcz@gmail.com

Site Name: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name: Klinika Nowotworów Układu Chłonnego
Principal Investigator Name: Jan Walewski
Principal Investigator Email: jan.walewski@pib-nio.pl
Contact Person Name: Jan Walewski
Contact Person Email: jan.walewski@pib-nio.pl

Site Name: Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu
Department Name: Oddział Hematologiczny
Principal Investigator Name: Szymon Fornagiel
Principal Investigator Email: ho@szpitalnowysacz.pl
Contact Person Name: Szymon Fornagiel
Contact Person Email: ho@szpitalnowysacz.pl

Site Name: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name: Oddział Kliniczny Hematologii
Principal Investigator Name: Artur Jurszczyszyn
Principal Investigator Email: mmjurczy@cyf-kr.edu.pl
Contact Person Name: Artur Jurszczyszyn
Contact Person Email: mmjurczy@cyf-kr.edu.pl

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

Site Name: Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Department Name: Oddział Hematologii
Principal Investigator Name: Aleksandra Butrym
Principal Investigator Email: aleksandra.butrym@gmail.com
Contact Person Name: Aleksandra Butrym
Contact Person Email: aleksandra.butrym@gmail.com

France

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 23-04-2026
Processing Time Days: 681
Number Of Sites: 8
Number Of Participants: 72

Sites

Site Name: Centre Hospitalier Universitaire De Lille
Department Name: 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: Assistance Publique Hopitaux De Paris
Department Name: Service d'Hématologie Clinique
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: Assistance Publique Hopitaux De Paris
Department Name: Service d'Immuno-Hématologie
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 Victor Dupouy
Department Name: Service d’Hématologie
Principal Investigator Name: Emmanuelle LE RAY
Principal Investigator Email: emmanuelle.leray@ch-argenteuil.fr
Contact Person Name: Emmanuelle LE RAY
Contact Person Email: emmanuelle.leray@ch-argenteuil.fr

Site Name: Centre Henri Becquerel
Department Name: Service d’Hématologie
Principal Investigator Name: Pascal LENAIN
Principal Investigator Email: pascal.lenain@chb.unicancer.fr
Contact Person Name: Pascal LENAIN
Contact Person Email: pascal.lenain@chb.unicancer.fr

Site Name: Centre Hospitalier Departemental Vendee
Department Name: Service d'Hémato-Oncologie
Principal Investigator Name: Mourad TIAB
Principal Investigator Email: mourad.tiab@ght85.fr
Contact Person Name: Mourad TIAB
Contact Person Email: mourad.tiab@ght85.fr

Site Name: CHRU De Nancy
Department Name: Service d'Hématologie
Principal Investigator Name: Pierre FEUGIER
Principal Investigator Email: p.feugier@chru-nancy.fr
Contact Person Name: Pierre FEUGIER
Contact Person Email: p.feugier@chru-nancy.fr

Site Name: Centre Hospitalier Universitaire De Toulouse
Department Name: Service d'Hématologie
Principal Investigator Name: Aurore PERROT
Principal Investigator Email: perrot.aurore@iutc-oncopole.fr
Contact Person Name: Aurore PERROT
Contact Person Email: perrot.aurore@iutc-oncopole.fr

Greece

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 22-04-2026
Processing Time Days: 680
Number Of Sites: 4
Number Of Participants: 48

Sites

Site Name: Alexandra Hospital
Department Name: Plasma cell dyscrasias unit, Department of Clinical Therapeutics
Principal Investigator Name: Maria Gavriatopoulou
Principal Investigator Email: mariagabria@gmail.com
Contact Person Name: Maria Gavriatopoulou
Contact Person Email: mariagabria@gmail.com

Site Name: Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name: Hematology Department and Bone Marrow Transplantation 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: Olympion Therapeftirio General Clinic Of Patras S.A.
Department Name: Hematology Department
Principal Investigator Name: Anargyros Symeonidis
Principal Investigator Email: argiris.symeonidis@yahoo.gr
Contact Person Name: Anargyros Symeonidis
Contact Person Email: argiris.symeonidis@yahoo.gr

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

Portugal

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 23-04-2026
Processing Time Days: 681
Number Of Sites: 3
Number Of Participants: 18

Sites

Site Name: Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name: Hematologia Clínica
Principal Investigator Name: Catarina Campos Costa
Principal Investigator Email: catarina.moreira@ipoporto.min-saude.pt
Contact Person Name: Catarina Campos Costa
Contact Person Email: catarina.moreira@ipoporto.min-saude.pt

Site Name: Champalimaud Clinical Centre
Department Name: Hemato-Oncologia
Principal Investigator Name: Paulo Lucio
Principal Investigator Email: paulo.lucio@fundacaochampalimaud.pt
Contact Person Name: Paulo Lucio
Contact Person Email: paulo.lucio@fundacaochampalimaud.pt

Site Name: Unidade Local De Saude De Coimbra E.P.E.
Department Name: Hematologia Clínica
Principal Investigator Name: Catarina Geraldes dos Santos
Principal Investigator Email: catarina.geraldes@chuc.min-saude.pt
Contact Person Name: Catarina Geraldes dos Santos
Contact Person Email: catarina.geraldes@chuc.min-saude.pt

Denmark

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 22-04-2026
Processing Time Days: 680
Number Of Sites: 3
Number Of Participants: 11

Sites

Site Name: Region Sjaelland
Department Name: Hæmatologisk afdeling
Principal Investigator Name: Trung HieuDo
Principal Investigator Email: trhd@regionsjaelland.dk
Contact Person Name: Trung HieuDo
Contact Person Email: trhd@regionsjaelland.dk

Site Name: Odense University Hospital
Department Name: Hæmatologisk afdeling
Principal Investigator Name: Charlotte Toftmann Hansen
Principal Investigator Email: Charlotte.Toftmann.Hansen2@rsyd.dk
Contact Person Name: Charlotte Toftmann Hansen
Contact Person Email: Charlotte.Toftmann.Hansen2@rsyd.dk

Site Name: Aalborg University Hospital
Department Name: Hæmatologisk afdeling
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: 11-06-2024
Latest Decision Or Authorization Date: 27-04-2026
Processing Time Days: 685
Number Of Sites: 4
Number Of Participants: 24

Sites

Site Name: Universitaetsklinikum Heidelberg AöR
Department Name: Medizinische Klinik V
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 Frankfurt AöR
Department Name: Medizinischen Klinik II (Hämatologie/ Onkologie)
Principal Investigator Name: Ivana Von Metzler
Principal Investigator Email: metzler@med.uni-frankfurt.de
Contact Person Name: Ivana Von Metzler
Contact Person Email: metzler@med.uni-frankfurt.de

Site Name: Asklepios Kliniken Hamburg GmbH
Department Name: Klinik für Innere Medizin 2Onkologie und Palliativmedizin mit Sektionen Hämatologie und Rheumatol
Principal Investigator Name: Hans-Jürgen Salwender
Principal Investigator Email: h.salwender@asklepios.com
Contact Person Name: Hans-Jürgen Salwender
Contact Person Email: h.salwender@asklepios.com

Site Name: University Medical Center Hamburg-Eppendorf
Department Name: Medizinische Klinik und Poliklinik (Onkologie, Hämatologie, Knochenmarktranspl. m. Abtlg. Pneumol
Principal Investigator Name: Katja Weisel
Principal Investigator Email: k.weisel@uke.de
Contact Person Name: Katja Weisel
Contact Person Email: k.weisel@uke.de

Austria

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 24-04-2026
Processing Time Days: 682
Number Of Sites: 6
Number Of Participants: 24

Sites

Site Name: Ordensklinikum Linz GmbH
Department Name: I. Internal department Hematology and Oncology
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: Noe LGA Gesundheit Region Mitte GmbH
Department Name: Department of Internal Medicine 1
Principal Investigator Name: Martin Wiesholzer
Principal Investigator Email: martin.wiesholzer@stpoelten.lknoe.at
Contact Person Name: Martin Wiesholzer
Contact Person Email: martin.wiesholzer@stpoelten.lknoe.at

Site Name: SCRI CCCIT Ges.m.b.H.
Department Name: University Clinic for Internal Medicine III of the PMU
Principal Investigator Name: Alexander Egle
Principal Investigator Email: a.egle@salk.at
Contact Person Name: Alexander Egle
Contact Person Email: a.egle@salk.at

Site Name: Medical University Of Graz
Department Name: Department of Internal Medicine Division of Hematology
Principal Investigator Name: Peter Neumeister
Principal Investigator Email: peter.neumeister@medunigraz.at
Contact Person Name: Peter Neumeister
Contact Person Email: peter.neumeister@medunigraz.at

Site Name: Stadt Wien Wiener Gesundheitsverbund
Department Name: 1. Medical Department – Center of Oncology and Hematology Pavillon 23
Principal Investigator Name: Karl Mayrhofer
Principal Investigator Email: karl.mayrhofer@gesundheitsverbund.at
Contact Person Name: Karl Mayrhofer
Contact Person Email: karl.mayrhofer@gesundheitsverbund.at

Site Name: Medical University Of Vienna
Department Name: Department Internal Medicine I Division Hematology and Hemostaseology
Principal Investigator Name: Maria Krauth
Principal Investigator Email: maria.krauth@meduniwien.ac.at
Contact Person Name: Maria Krauth
Contact Person Email: maria.krauth@meduniwien.ac.at

Spain

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 24-04-2026
Processing Time Days: 682
Number Of Sites: 14
Number Of Participants: 64

Sites

Site Name: University Clinical Hospital Virgen De La Arrixaca
Department Name: Servicio de Hematologia
Principal Investigator Name: Valentin Cabañas Perianes
Principal Investigator Email: valentin.cabanas@gmail.com
Contact Person Name: Valentin Cabañas Perianes
Contact Person Email: valentin.cabanas@gmail.com

Site Name: Hospital De La Santa Creu I Sant Pau
Department Name: Servicio de Hematologia
Principal Investigator Name: Jordi Lopez Pardo
Principal Investigator Email: evilarrasa@santpau.cat
Contact Person Name: Jordi Lopez Pardo
Contact Person Email: evilarrasa@santpau.cat

Site Name: Hospital Universitario Reina Sofia
Department Name: Servicio de Hematologia
Principal Investigator Name: Miguel Angel Alvarez Rivas
Principal Investigator Email: Mangel.alvarez.sspa@juntadeandalucia.es
Contact Person Name: Miguel Angel Alvarez Rivas
Contact Person Email: Mangel.alvarez.sspa@juntadeandalucia.es

Site Name: Hospital Universitario Ramon Y Cajal
Department Name: Servicio de Hematologia
Principal Investigator Name: Maria Jesus Blanchard
Principal Investigator Email: mjesusblanchard@yahoo.es
Contact Person Name: Maria Jesus Blanchard
Contact Person Email: mjesusblanchard@yahoo.es

Site Name: Hospital Universitario Virgen De La Victoria
Department Name: Servicio de Hematologia
Principal Investigator Name: Ricarda Garcia Sanchez
Principal Investigator Email: ricarda_g@yahoo.es
Contact Person Name: Ricarda Garcia Sanchez
Contact Person Email: ricarda_g@yahoo.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: Complexo Hospitalario Universitario De Santiago
Department Name: Servicio de Hematologia
Principal Investigator Name: Marta Sonia Gonzalez Perez
Principal Investigator Email: marta.sonia.gonzalez.perez@sergas.es
Contact Person Name: Marta Sonia Gonzalez Perez
Contact Person Email: marta.sonia.gonzalez.perez@sergas.es

Site Name: Hospital Universitario Y Politecnico La Fe
Department Name: Servicio de Hematologia
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 Universitario Fundacion Jimenez Diaz
Department Name: Servicio de Hematologia
Principal Investigator Name: Elham Askari
Principal Investigator Email: easkari@quironsalud.es
Contact Person Name: Elham Askari
Contact Person Email: easkari@quironsalud.es

Site Name: Hospital Universitario Miguel Servet
Department Name: Servicio de Hematologia
Principal Investigator Name: Araceli Rubio Martinez
Principal Investigator Email: arubiom@salud.aragon.es
Contact Person Name: Araceli Rubio Martinez
Contact Person Email: arubiom@salud.aragon.es

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

Site Name: Hospital Universitario De La Princesa
Department Name: Servicio de Hematologia
Principal Investigator Name: Adrian Alegre Amor
Principal Investigator Email: adrian.alegre@telefonica.net
Contact Person Name: Adrian Alegre Amor
Contact Person Email: adrian.alegre@telefonica.net

Site Name: Hospital Universitario Central De Asturias
Department Name: Servicio de Hematologia
Principal Investigator Name: Angel Ramirez Payer
Principal Investigator Email: apayer.angel@gmail.com
Contact Person Name: Angel Ramirez Payer
Contact Person Email: apayer.angel@gmail.com

Site Name: Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Department Name: Servicio de Hematologia
Principal Investigator Name: Mercedes Gironella Mesa
Principal Investigator Email: merce.gironella@vallhebron.cat
Contact Person Name: Mercedes Gironella Mesa
Contact Person Email: merce.gironella@vallhebron.cat

Ireland

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 22-04-2026
Processing Time Days: 680
Number Of Sites: 3
Number Of Participants: 10

Sites

Site Name: Cork University Hospital
Department Name: Haematology
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: Beaumont Hospital
Department Name: Cancer Clinical Trials and Research Unit
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 Galway
Department Name: Haematology
Principal Investigator Name: Janusz Krawczyk
Principal Investigator Email: Janusz.Krawczyk@nuigalway.ie
Contact Person Name: Janusz Krawczyk
Contact Person Email: Janusz.Krawczyk@nuigalway.ie

Netherlands

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 23-04-2026
Processing Time Days: 681
Number Of Sites: 3
Number Of Participants: 12

Sites

Site Name: Albert Schweitzer Ziekenhuis
Department Name: Hematology
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

Site Name: Amsterdam UMC Stichting
Department Name: 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

Site Name: Haga Hospital
Department Name: Hematology
Principal Investigator Name: Paula Ypma
Principal Investigator Email: p.ypma@hagaziekenhuis.nl
Contact Person Name: Paula Ypma
Contact Person Email: p.ypma@hagaziekenhuis.nl

Finland

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 23-04-2026
Processing Time Days: 681
Number Of Sites: 3
Number Of Participants: 10

Sites

Site Name: Turku University Hospital
Department Name: Turku University Hospital, TE6, Clinical Haematology and Stem cell Transplant unit
Principal Investigator Name: Mervi Putkonen
Principal Investigator Email: mervi.putkonen@varha.fi
Contact Person Name: Mervi Putkonen
Contact Person Email: mervi.putkonen@varha.fi

Site Name: HUS-Yhtymae
Department Name: Helsinki University Hospital, Comprehensive Cancer Centre
Principal Investigator Name: Sini Luoma
Principal Investigator Email: sini.luoma@hus.fi
Contact Person Name: Sini Luoma
Contact Person Email: sini.luoma@hus.fi

Site Name: Oulu University Hospital
Department Name: Olulu University Hospital,Cancer center Department of Haematology
Principal Investigator Name: Marjaana Saily
Principal Investigator Email: marjaana.saily@pohde.fi
Contact Person Name: Marjaana Saily
Contact Person Email: marjaana.saily@pohde.fi

Belgium

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 22-04-2026
Processing Time Days: 680
Number Of Sites: 1
Number Of Participants: 11

Sites

Site Name: Az St-Jan Brugge-Oostende A.V.
Department Name: Hematology
Principal Investigator Name: Jan Van Droogenbroeck
Principal Investigator Email: jan.vandroogenbroeck@azsintjan.be
Contact Person Name: Jan Van Droogenbroeck
Contact Person Email: jan.vandroogenbroeck@azsintjan.be

Italy

Earliest CTIS Part Ii Submission Date: 11-06-2024
Latest Decision Or Authorization Date: 24-04-2026
Processing Time Days: 682
Number Of Sites: 11
Number Of Participants: 32

Sites

Site Name: Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name: UO 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: IRCCS Ospedale Policlinico San Martino
Department Name: Clinica Ematologica
Principal Investigator Name: Michele Cea
Principal Investigator Email: michele.cea@unige.it
Contact Person Name: Michele Cea
Contact Person Email: michele.cea@unige.it

Site Name: Azienda Ospedaliero-Universitaria Sant Andre
Department Name: UO Ematologia
Principal Investigator Name: Giacinto La Verde
Principal Investigator Email: giacintolaverde@gmail.com
Contact Person Name: Giacinto La Verde
Contact Person Email: giacintolaverde@gmail.com

Site Name: Azienda Ospedaliero Universitaria Pisana
Department Name: UO Ematologia
Principal Investigator Name: Gabriele Buda
Principal Investigator Email: ga.buda@libero.it
Contact Person Name: Gabriele Buda
Contact Person Email: ga.buda@libero.it

Site Name: Azienda Ospedaliero-Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name: U.O di Ematologia con Trapianto di Midollo Osseo
Principal Investigator Name: Concetta Conticello
Principal Investigator Email: ettaconticello@gmail.com
Contact Person Name: Concetta Conticello
Contact Person Email: ettaconticello@gmail.com

Site Name: Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Department Name: UO Ematologia
Principal Investigator Name: Iolanda Donatella Vincelli
Principal Investigator Email: donatella.vincelli@gmail.com
Contact Person Name: Iolanda Donatella Vincelli
Contact Person Email: donatella.vincelli@gmail.com

Site Name: Casa Sollievo Della Sofferenza
Department Name: U.O.C. 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 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: Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name: SCDU 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: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name: UOC Ematologia
Principal Investigator Name: Niccolò Bolli
Principal Investigator Email: niccolo.bolli@policlinico.mi.it
Contact Person Name: Niccolò Bolli
Contact Person Email: niccolo.bolli@policlinico.mi.it

Site Name: Azienda Ospedaliero-Universitaria Policlinico G Rodolico San Marco Di Catania (duplicate listing if present)

Sponsor

Primary sponsor

Full Name: Celgene Corp.
Organisation Type: Pharmaceutical company
Country Of Registered Address: United States

Contract research organisations

Name: Frontage Laboratories Inc.
Responsibilities: PK analyses

Name: PPD Development LP

Name: PPD Global Ltd.
Responsibilities: Project management duties and monitoring/regulatory

Name: Quintiles Laboratories Ltd.
Responsibilities: Flow Cytometry

Name: Endpoint Clinical Inc.
Responsibilities: IVRS30 – treatment randomisation

Third parties

{"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"PK analyses","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Clinical chemistry, Clinical haematology","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Flow Cytometry","organisation_type":"Non-Pharmaceutical company"}
{"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Quintiles Laboratories Ltd.","duties_or_roles":"Flow Cytometry","organisation_type":"Pharmaceutical company"}
{"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
{"country":"Malaysia","full_name":"Hematogenix","duties_or_roles":"Logistic Support of samples, kit management, Flow Cytometry, Morphological Assessment","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"Logistic Support of samples, kit management, Flow Cytometry, Morphological Assessment","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Project management duties and monitoring/regulatory","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Hematogenix Laboratory Services Limited","duties_or_roles":"Logistic Support of samples, kit management, Flow Cytometry, Morphological Assessment","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Providing Dara ancillary supplies","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS30 – treatment randomisation","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: Iberdomide
Active Substance: IBERDOMIDE
Modality: Small molecule
Routes Of Administration: Oral
Route: Oral
Starting Dose: 1 mg
Dose Levels: 1 mg, 1.3 mg, 1.6 mg
Frequency: Once daily on Days 1–21 of a 28-day cycle
Maximum Dose: 1.6 mg
Dose Escalation Increase: 1 mg -> 1.3 mg -> 1.6 mg

Investigational Product Name: Dexamethasone
Active Substance: DEXAMETHASONE
Modality: Small molecule
Routes Of Administration: Oral
Route: Oral
Authorisation Status: Authorised
Starting Dose: Arm A: total 40 mg weekly (Days 1, 8, 15, 22); Arm B: starting dose 20 mg
Frequency: Weekly (per arm schedule)
Maximum Dose: 40 mg (weekly total)

Investigational Product Name: Bortezomib
Active Substance: BORTEZOMIB
Modality: Small molecule
Routes Of Administration: Subcutaneous
Route: Subcutaneous
Starting Dose: 1.3 mg/m2 (subcutaneous, starting dose)
Maximum Dose: 1.3 mg/m2

Investigational Product Name: Daratumumab (DARZALEX 1800 mg solution for injection)
Active Substance: DARATUMUMAB
Modality: Monoclonal antibody
Routes Of Administration: Subcutaneous
Route: Subcutaneous
Authorisation Status: Authorised (EU)
Orphan Designation: Yes
Starting Dose: 1800 mg subcutaneously
Maximum Dose: 1800 mg

Combination Treatment: Yes

Related trials

Other published trials that may interest you.