Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
398
Countries
13
Sites
49
Relapsed or Refractory Multiple Myeloma (RRMM)
To evaluate the efficacy, safety, and tolerability of etentamig administered as monotherapy in adult subjects with RRMM who have received at least 2 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 mAb.
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Jun 2024 → ongoing
- Decision date (initial)
- 2024-05-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
To evaluate the efficacy, safety, and tolerability of etentamig administered as monotherapy in adult subjects with RRMM who have received at least 2 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 mAb.
Conditions and MedDRA coding
Relapsed or Refractory Multiple Myeloma (RRMM)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Adult individuals, male or female, ≥18 years old.
- Subject must be eligible to receive the Investigator's choice SAT based on approved prescribing information, previous MM treatment history, and institutional guidelines.
- Subjects must accept to be treated with one of the pre-specified Standard Available Therapies (SAT), based on Investigator's choice of local standard of care.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Subjects must meet the laboratory parameters, as specified in the study protocol, within 2 weeks prior of the first dose of study treatment.
- Subjects must has a diagnosis of relapsed and/or refractory MM during or after the subject's last treatment
- Subjects must have measurable disease within 28 days prior to randomization, defined as at lease 1 of the following: Serum monoclonal paraprotein (M-protein) ≥0.5 g/dL (≥5 g/L); Urine M-protein ≥200 mg/24 hours; In subjects without measurable serum or urine M-protein, serum FLC ≥100 mg/L (10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio.
- Subject must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.
- Subject with known HIV will be permitted provided that the subject has an undetectable HIV viral load by standard clinical assays on antiretroviral medication (HAART) and is able to tolerate study treatment per Investigator's judgement.
- Unresolved adverse reactions or toxicities from prior anticancer therapies must have resolved to Grade 1 or baseline (NCI CTCAE Version 5.0), except for alopecia or fatigue. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss) at the discretion of the investigator.
Exclusion criteria 15
- History of significant cardiovascular or pericardial disease, including uncontrolled angina, arrhythmia, recent myocardial infarction within 6 months of first dose, Class ≥3 New York Heart Association congestive heart failure.
- Subjects have evidence of active hepatitis C infection based on screening blood testing.
- Subject has any of the following conditions: - Non-secretory MM; - Active plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 109 /L circulating plasma cells by standard differential; - Waldenstrom's macroglobulinemia; - Light chain amyloidosis; - POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes); - Major surgery within 21 days prior to first dose or during planned study participation; or Acute infections within 14 days prior to first dose of study treatment requiring therapy (antibiotic, antifungal, or antiviral).
- SAT-Specific Exclusion Criteria: Subject is not eligible to receive Kd if subject has received prior carfilzomib therapy.
- SAT-Specific Exclusion Criteria: Subject is not eligible to receive SVd if: - Subject has received prior selinexor therapy; - Prior PI treatment is allowed provided that subject achieved ≥PR with no history of discontinuation due to ≥Grade 3 toxicity.
- SAT-Specific Exclusion Criteria: Subject is not eligible to receive EloPd if subject has received prior elotuzumab or pomalidomide therapy.
- Subject have a known active SARS-CoV-2 infection. If a subject has signs/symptoms suggestive of SARS-CoV- 2 infection, the subject must have a negative molecular (e.g., PCR) test or 2 negative antigen test results at least 24 hours apart.
- History of clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the subject's participation in the study.
- History of any malignancy within the past 3 years with the following exceptions: - Adequately treated in situ carcinoma of the cervix uteri or the breast; - Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; - Prostate cancer Gleason Grade 6 or lower AND with stable PSA levels on or off treatment; - Previous malignancy with no evidence of disease confirmed and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
- Subjects have received BCMA-targeted therapy
- Subjects have known central nervous system involvement of MM.
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
- Known allergies, hypersensitivities, or intolerance to constituents of the study treatment (and its excipients) or derivatives.
- Subjects have evidence of active hepatitis B (HbsAg positive) infection based on screening blood testing (HBsAg, antiHBc, antiHBs).
- SAT-Specific Exclusion Criteria: Subject is not eligible to receive SAT if subject has an ongoing condition or history of a condition which is an exclusion per local (or applicable) approved label, package insert, and/or institutional guidelines for any single agent from SAT regimen.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Progression Free Survival (PFS) with Progressive Disease (PD) assessed according to the IMWG (2016) response criteria, per IRC assessment
- Overall Response Rate (ORR) per IMWG (2016) response criteria (defined as PR + VGPR + CR + sCR) per IRC assessment
Secondary endpoints 13
- Overall Survival (OS)
- Rate of ≥VGPR per IRC assessment
- Rate of ≥CR per IRC assessment
- Rate of MRD negativity with ≥CR, defined as achievement of CR or better by IMWG (2016) response criteria (per IRC assessment) and MRD negative status as assessed by NGS Adaptive Clonoseq at 10- 5 threshold
- Change from baseline at 6 months in disease symptoms as measured by the disease symptoms domain of the EORTC QLQ-MY20
- Change from baseline at 6 months in physical functioning as measured by the physical functioning domain of the EORTC QLQ-C30
- Time to response (TTR) per IRC assessment
- Duration of response (DoR) per IRC assessment
- Time to Disease Progression (TTP) per IRC assessment
- Time to Next Therapy (TTNT)
- Event free survival (EFS)
- Patient Reported Outcomes (PROs): Change from baseline in the score of remaining scales and items of the EORTC QLQ-C30 and EORTC QLQ-MY20, PROMIS Fatigue SF 7a, EQ-5D-5L, PGIS; scores/frequencies of PGIS, PGIC and select items of the PRO-CTCAE
- Skeletal-related event (SREs), defined as presence of any of the following events: - spinal cord compression; - pathologic fracture; - surgery to bone; - radiation to bone
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9603555 · Product
- Active substance
- Etentamig
- Substance synonyms
- ABBV-383, Human IgG4 monoclonal antibody against BCMA and CD3, TNB-383B
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 11
SUB121695 · Substance
- Active substance
- Elotuzumab
- Pharmaceutical form
- POWDER FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB177942 · Substance
- Active substance
- Selinexor
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32911 · Substance
- Active substance
- Carfilzomib
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB33379 · Substance
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB33379 · Substance
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB33379 · Substance
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB33379 · Substance
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20020 · Substance
- Active substance
- Bortezomib
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20020 · Substance
- Active substance
- Bortezomib
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 4
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07211MIG · Substance
- Active substance
- Diphenhydramine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07211MIG · Substance
- Active substance
- Diphenhydramine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Laboratory analysis |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Abbvie Inc. ORG-100006292
|
North Chicago, United States | Laboratory analysis |
| Patient Advertising Guru Inc. ORG-100046268
|
Melville, United States | Other |
| Cytel Inc. ORG-100042560
|
Waltham, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| AbbVie Deutschland GmbH & Co. KG ORG-100001365
|
Ludwigshafen Am Rhein, Germany | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
Locations
13 EU/EEA countries · 49 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 9 | 4 |
| Belgium | Ongoing, recruitment ended | 6 | 2 |
| Czechia | Ongoing, recruitment ended | 11 | 4 |
| Denmark | Ongoing, recruitment ended | 6 | 2 |
| France | Ongoing, recruitment ended | 13 | 4 |
| Germany | Ongoing, recruitment ended | 9 | 6 |
| Greece | Ongoing, recruitment ended | 10 | 4 |
| Hungary | Ongoing, recruitment ended | 13 | 3 |
| Italy | Ongoing, recruitment ended | 13 | 5 |
| Poland | Ongoing, recruitment ended | 15 | 3 |
| Portugal | Ongoing, recruitment ended | 8 | 3 |
| Spain | Ongoing, recruitment ended | 14 | 6 |
| Sweden | Ongoing, recruitment ended | 20 | 3 |
| Rest of world
China, Canada, United States, United Kingdom, Korea, Republic of, Japan, Australia, Israel, Taiwan, South Africa, Turkey
|
— | 251 | — |
Investigational sites
Medical University Of Graz
Department of Hematology, Neue Stiftingtalstrasse 6, 8010, Graz
Universitaetsklinikum Krems
Department of Internal Medicine II, Clinical Department of Oncology and Hematology, Mitterweg 10, 3500, Krems An Der Donau
Stadt Wien Wiener Gesundheitsverbund
I. Medical Department, Montleartstrasse 37, Ottakring, Vienna
Ordensklinikum Linz GmbH
Department of Hematology and Oncology, Fadingerstrasse 1, 4020, Linz
Az St-Jan Brugge-Oostende A.V.
Hematology, Ruddershove 10, 8000, Brugge
Algemeen Ziekenhuis Klina
Hematology, Augustijnslei 100, 2930, Brasschaat
Vseobecna Fakultni Nemocnice V Praze
I. Interni Klinika - Hematologie, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Hradec Kralove
IV. interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Lillebaelt Hospital
Department of Hematology, Beriderbakken 4, 7100, Vejle
Odense University Hospital
Department of Hematology, J B Winsloews Vej 4, 5000, Odense C
Centre Hospitalier Le Mans
Centre de cancérologie de la Sarthe, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Regional D'Orleans
Service d'hématologie, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Centre Hospitalier D Avignon
Service d'onco-hématologie, 305 Rue Raoul Follereau, 84000, Avignon
Centre Hospitalier De Saint-Quentin
Service d'onco-hématologie, 1 Rue Michel De L Hospital, 02100, Saint Quentin
Klinikum Chemnitz gGmbH
N/A, Flemmingstrasse 2, Altendorf, Chemnitz
Staedtisches Klinikum Karlsruhe gGmbH
N/A, Moltkestrasse 90, Weststadt, Karlsruhe
Charite Universitaetsmedizin Berlin KöR
N/A, Hindenburgdamm 30, Lichterfelde, Berlin
Medical Center - University Of Freiburg
N/A, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
University Medical Center Hamburg-Eppendorf
N/A, Martinistrasse 52, Eppendorf, Hamburg
Centrum für Hämatologie und Onkologie Bethanien
N/A, Im Prüfling 17-19, 60389, Frankfurt am Main
Evaggelismos Hospital
Haematology Department, Ipsiladou 45-47, 106 76, Athens
University General Hospital Of Thessaloniki Ahepa
1st Department of Internal Medicine, Division of Hematology, 1st St Kiriakidis Str, 546 36, Thessaloniki
Alexandra Hospital
Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
University General Hospital Attikon
2nd Department of Internal Medicine- Propaedeutic, Hematology Unit, Rimini Street 1, 124 62, Athens
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
II. Belgyogyaszat – Hematologia, Vasvari Pal Utca 2-4, 9024, Gyor
Semmelweis University
Belgyogyaszati es Hematologiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Semmelweis University
Belgyogyaszati es Hematologiai Klinika, B. epulet, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Azienda Ospedaliero Universitaria Delle Marche
Internal Medicine Department, Via Conca 71, 60126, Ancona
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department of "Biotecnologie Molecolari e Scienze per la Salute", Corso Bramante 88, 10126, Turin
Azienda Socio Sanitaria Territoriale Ovest Milanese
Oncology, Via Papa Giovanni Paolo II, 20025, Legnano
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Ematologia, dipartimento di Medicina Traslazionale e di Precisione, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
UOC di Ematologia, Via Santa Sofia 78, 95123, Catania
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Klinika Hematoonkologii, Transplantacji Szpiku i Chemioterapii, Ul. Stanislawa Staszica 11, 20-081, Lublin
Champalimaud Clinical Centre
Unidade de Hemato-Oncologia, Avenida Brasilia S/n, 1400-038, Lisbon
Hospital De Santa Maria E.P.E.
Serviço de Hematologia e Transplantação de Medula, Avenida Professor Egas Moniz Piso 3, 1649-028, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Serviço de Hematologia e Transplantação de Medula Ósses, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Institut Catala D'oncologia
Servicio de Hematologia, Carretera Canyet S/n, 08916, Badalona
Area De Salud De Leon Y El Bierzo
Servicio de Hematologia, Calle Altos De Nava S/N, 24008, Leon
Hospital Universitario Y Politecnico La Fe
Servicio de Hematologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital General Universitario Gregorio Maranon
Servicio de Hematologia, Calle Del Doctor Esquerdo 46, 28009, Madrid
Complejo Hospitalario Universitario De Ourense
Servicio de Hematologia, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital Universitario De Salamanca
Servicio de Hematologia, Paseo De San Vicente 58-182, 37007, Salamanca
Region Dalarna
Falu Lasarett Hematologimottagningen, Medicinkliniken 791 82 Falun, Vasagatan 27, Falu Kristine, Falun
NU Hospital Group-Vastra Gotalandsregionen
Uddevalla Hospital, Department of Medicine, Section of Hematology, Fjällvagen 9, 451 80 Uddevalla, Larketorpsvagen, 461 85, Trollhattan
Region Skane Helsingborg Hospital
Helsingborg Lasarett, Hematology Section Charlotte Yhlens Gata 10 252 23 Helsingborg, Charlotte Yhlens Gata 10, Helsingborgs Maria, Helsingborg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-07-03 | 2024-08-09 | 2026-02-24 | ||
| Belgium | 2024-09-19 | 2025-03-18 | 2026-02-24 | ||
| Czechia | 2024-10-31 | 2025-01-21 | 2026-02-24 | ||
| Denmark | 2024-08-29 | 2025-03-06 | 2026-02-24 | ||
| France | 2024-07-11 | 2024-08-21 | 2026-02-24 | ||
| Germany | 2024-08-29 | 2025-02-17 | 2026-02-24 | ||
| Greece | 2024-08-01 | 2024-09-04 | 2026-02-24 | ||
| Hungary | 2024-09-16 | 2024-10-21 | 2026-02-24 | ||
| Italy | 2024-09-24 | 2024-11-06 | 2026-02-24 | ||
| Poland | 2024-08-27 | 2024-08-29 | 2026-02-24 | ||
| Portugal | 2024-06-20 | 2024-10-18 | 2026-02-24 | ||
| Spain | 2024-06-17 | 2024-11-12 | 2026-02-24 | ||
| Sweden | 2024-06-19 | 2024-09-09 | 2026-02-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 155 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m22574-protocol_public_Redacted | 3.0 |
| Protocol (for publication) | D1_m22574-protocol-gr_public_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K1 M22-574 CZ Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1 M22-574 DE Recruitment and ICF Procedures_Public | 3.0 |
| Recruitment arrangements (for publication) | K1 M22-574 HU Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1 M22-574 IT Recruitment and ICF Procedures Public | 3 |
| Recruitment arrangements (for publication) | K1 M22-574 PL Recruitment and ICF Procedures Public | 3 |
| Recruitment arrangements (for publication) | K1 M22-574 SE Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1_M22-574 AT Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M22-574 BE Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M22-574 ES Recruitment and ICF Procedures Public | 1.0 |
| Recruitment arrangements (for publication) | K1_M22-574 FR Recruitment and ICF Procedures_Public | 3.0 |
| Recruitment arrangements (for publication) | K1_M22-574 PT Recruitment and ICF Procedures Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M22-574- EU CTR Recruitment and ICF Procedures | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 CZ Recruitment Poster_Public | 2.0 |
| Recruitment arrangements (for publication) | K2 M22-574 CZ ICF Flipchart_Public | 2.0 |
| Recruitment arrangements (for publication) | K2 M22-574 CZ Recruitment Brochure_Public | 2.0 |
| Recruitment arrangements (for publication) | K2 M22-574 CZ Website_Public | 2.0 |
| Recruitment arrangements (for publication) | K2 M22-574 DE Ad and Recruitment Brochure German_Public | 3 |
| Recruitment arrangements (for publication) | K2 M22-574 DE Ad and Recruitment Flipchart German_Public | 3 |
| Recruitment arrangements (for publication) | K2 M22-574 DE Ad and Recruitment Physician to Patient Letter German_Public | 3 |
| Recruitment arrangements (for publication) | K2 M22-574 DE Ad and Recruitment Poster German_Public | 3 |
| Recruitment arrangements (for publication) | K2 M22-574 DE Ad and Recruitment Website German_Public | 4 |
| Recruitment arrangements (for publication) | K2 M22-574 HU Doctor to Patient Letter_Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 HU ICF Flipchart_Hungarian_Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 HU Recruitment Brochure_Hungarian_Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 HU Recruitment Poster_Hungarian_Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 IT Digital Ads A_Public | 1 |
| Recruitment arrangements (for publication) | K2 M22-574 IT Digital Ads B_Public | 1 |
| Recruitment arrangements (for publication) | K2 M22-574 IT Digital Ads BCMA Public | 1 |
| Recruitment arrangements (for publication) | K2 M22-574 IT Digital Ads C_Public | 1 |
| Recruitment arrangements (for publication) | K2 M22-574 IT Digital Ads D_Public | 1 |
| Recruitment arrangements (for publication) | K2 M22-574 IT Digital Ads E_Public | 1 |
| Recruitment arrangements (for publication) | K2 M22-574 IT Digital Ads F_Public | 1 |
| Recruitment arrangements (for publication) | K2 M22-574 IT ICF Flipchart Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 IT Physician to Patient letter Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 IT Recruitment Brochure Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 IT Recruitment Poster Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 IT Website Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 PL Recruitment Brochure Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 PL Recruitment Poster Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 PL Website Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 SE ICF Flipchart_Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 SE Physician to Patient Letter_Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 SE Recruitment Brochure_Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 SE Recruitment Poster_Public | 2 |
| Recruitment arrangements (for publication) | K2 M22-574 SE Website_Public | 2 |
| Recruitment arrangements (for publication) | K2_M22-574 BE ICF Flipchart Dutch_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 BE ICF Flipchart French_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 BE PAG Website Dutch_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 BE PAG Website French_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 BE Physician to Patient Letter Dutch_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 BE Physician to Patient Letter French_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 BE Recruitment Brochure Dutch_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 BE Recruitment Brochure French_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 BE Recruitment Poster Dutch_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 BE Recruitment Poster French_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 FR ICF Flipchart_Public | 2 |
| Recruitment arrangements (for publication) | K2_M22-574 FR Physician to Patient Letter_Public | 2 |
| Recruitment arrangements (for publication) | K2_M22-574 FR Recruitment Brochure_Public | 2 |
| Recruitment arrangements (for publication) | K2_M22-574 FR Recruitment Poster_Public | 2 |
| Recruitment arrangements (for publication) | K2_M22-574 FR Website_Public | 2 |
| Recruitment arrangements (for publication) | K2_M22-574 PT ICF Flipchart Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 PT Physician to Patient Letter Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 PT Recruitment Brochure_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574 PT Recruitment Poster_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574_AT_ICF Flipchart_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574_AT_Physician to Patient Letter_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574_AT_Recruitment Brochure_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574_AT_Recruitment Poster_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574_AT_WebSite Text_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-574_DK_Recruitment and ICF Procedures clean_Public | 3 |
| Recruitment arrangements (for publication) | M22-574 BE ICF Flipchart German_Public | 1 |
| Recruitment arrangements (for publication) | M22-574 BE PAG Website German_Public | 1 |
| Recruitment arrangements (for publication) | M22-574 BE Physician to Patient Letter German_Public | 1 |
| Recruitment arrangements (for publication) | M22-574 BE Recruitment Brochure German_Public | 1 |
| Recruitment arrangements (for publication) | M22-574 BE Recruitment Poster German_Public | 1 |
| Recruitment arrangements (for publication) | M22-574 CZ Physician to Patient letter Czech_Public | 1 |
| Recruitment arrangements (for publication) | M22-574 PL ICF Flipchart Public | 1 |
| Subject information and informed consent form (for publication) | L1 M22-574 CZ ICF Optional_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M22-574 CZ ICF Preg Partner_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M22-574 FR ICF Addendum_Public | 1 |
| Subject information and informed consent form (for publication) | L1 M22-574 HU Optional ICF_Hungarian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M22-574 HU Optional PIS_Hungarian_Public redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1 M22-574 HU Pregnant Partner PIS and ICF_Hungarian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M22-574 IT ICF Pregnant authorization for data realease form Public | 3 |
| Subject information and informed consent form (for publication) | L1 M22-574 IT ICF Privacy Italian Public | 3 |
| Subject information and informed consent form (for publication) | L1 M22-574 PL ICF Main Public Redacted | 5 |
| Subject information and informed consent form (for publication) | L1 M22-574 PL ICF Optional Public | 3 |
| Subject information and informed consent form (for publication) | L1 M22-574 PL ICF Pregnant Partner Public | 3 |
| Subject information and informed consent form (for publication) | L1 M22-574 PT Combined Main and Optional ICF English_Public Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1 M22-574 SE ICF Pregnant Partner_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M22-574 SE Main ICF_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 AT ICF Main_public redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 BE ICF Main Dutch_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 BE ICF Main English_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 BE ICF Main French_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 BE ICF Other Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 BE ICF Other English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 BE ICF Other French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 BE ICF Preg Part Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 BE ICF Preg Part English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 BE ICF Preg Part French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 DK ICF Pregnant Partner Danish_Public | 2 |
| Subject information and informed consent form (for publication) | L1_M22-574 DK_ICF Main_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M22-574 DK_Optional Research ICF Danish_Public | 2 |
| Subject information and informed consent form (for publication) | L1_M22-574 ES ICF CTE Spanish Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_M22-574 ES ICF Main_ Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 ES ICF Optional_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 ES ICF Pregnant Partner Spanish Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_M22-574 FR Main ICF_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 FR Preg Part ICF_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 GR Main ICF_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M22-574 GR Optional ICF_Public | 3 |
| Subject information and informed consent form (for publication) | L1_M22-574 GR Preg Part ICF_Public | 2 |
| Subject information and informed consent form (for publication) | L1_M22-574 HU Main PIS and ICF_Hungarian_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 IT ICF Combined Main and Optional Public | 4 |
| Subject information and informed consent form (for publication) | L1_M22-574 PT Combined Main and Optional ICF English_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 PT Combined Main and Optional ICF Portuguese_Public Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 PT Pregnant Subject Data Release_Arm 1 English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 PT Pregnant Subject Data Release_Arm 1 Portuguese_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 PT Pregnant Subject Data Release_Arm 2 English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 PT Pregnant Subject Data Release_Arm 2 Portuguese_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 PT Pregnant Subject Data Release_Arm A English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M22-574 PT Pregnant Subject Data Release_Arm B English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M22-574_AT_Blank document-ICF Site Contact Details_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-574_AT_ICF Main German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-574_AT_ICF Pregnant Partner_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-574_CZ_ICF GDPR Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-574_CZ_ICF Main Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-574_DE_ICF Main_German_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-574_DE_ICF Pregnancy_German_public | 4.0 |
| Subject information and informed consent form (for publication) | L2 M22-574 HU Patient ID Card_Public | 2.0 |
| Subject information and informed consent form (for publication) | M22-574 DK_Rights of Subject before consent | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_smpc-bortezomib-3.5mg-powder-for-solution-for-injection_public | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_smpc-dexamethasone-2mg-tablets_public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_smpc-dexamethasone-3.3mg-ml-solutionforinjection_public | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_smpc-elotuzumab-400mg-powder-for-concentrate-for-solution-for-infusion_public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_smpc-imnovid-capsules_public | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_smpc-kyprolis-60mg-powder-for-solution-for-infusion_public | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_smpc-nexpovio-20mg-film-coated-tablets_public | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-CS-CZ | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-DE-AT | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-DE-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-EL-GR | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-EN-EN | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-ES-ES | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-FR-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-FR-FR | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-HU-HU | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-IT-IT | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-NL-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-PL-PL | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-PT-PT | 1 |
| Synopsis of the protocol (for publication) | D1_m22574-euctr-synopsis-SV-SE | 1 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-02 | France | Acceptable 2024-05-24
|
2024-05-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-31 | Acceptable 2024-05-24
|
2024-05-31 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-04 | Acceptable | 2024-08-05 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-04 | Acceptable | 2024-07-10 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-02 | France | Acceptable 2024-12-02
|
2024-12-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-07 | France | Acceptable 2025-05-19
|
2025-05-20 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-06 | France | Acceptable 2025-11-04
|
2025-11-04 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-11-28 | France | Acceptable 2026-01-27
|
2026-01-28 |