A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC (Tec-Dara) versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants with Relapsed or Refractory Multiple Myeloma

2023-503441-55-00 Protocol 64007957MMY3001 Therapeutic exploratory (Phase II) Ongoing, recruitment ended

Start 14 Oct 2021 · Status Ongoing, recruitment ended · 10 EU/EEA countries · 72 sites · Protocol 64007957MMY3001

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruitment ended
Participants planned 529
Countries 10
Sites 72

Relapsed/Refractory Multiple Myeloma

To compare the efficacy of Tec-Dara with DPd/DVd

Key facts

Sponsor
Janssen - Cilag International
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Hemic and Lymphatic Diseases [C15]
Trial duration
14 Oct 2021 → ongoing
Decision date (initial)
2024-07-19
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2023-503441-55-00
EudraCT number
2020-004742-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

To compare the efficacy of Tec-Dara with DPd/DVd

Conditions and MedDRA coding

Relapsed/Refractory Multiple Myeloma

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes
IPD plan description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparecy. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (≥) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level ≥200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
  2. Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion
  3. Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
  4. Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment
  5. Have clinical laboratory values within the specified range

Exclusion criteria 6

  1. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include: -A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG, -A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade ≥ 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization
  2. Received any prior B cell maturation antigen (BCMA)-directed therapy
  3. Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG
  4. Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14 days before randomization
  5. Received a live, attenuated vaccine within 4 weeks before randomization
  6. Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. PFS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 16

VELCADE 3.5 mg powder for solution for injection

PRD703624 · Product

Active substance
Bortezomib
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
L01XG01 — -
Marketing authorisation
EU/1/04/274/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

DARZALEX 1800 mg solution for injection

PRD8157846 · Product

Active substance
Daratumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
L01FC01 — -
Marketing authorisation
EU/1/16/1101/004
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/13/1153
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

teclistamab

PRD9936206 · Product

Active substance
Teclistamab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 µg/Kg microgram(s)/kilogram
Max total dose
0 µg/Kg microgram(s)/kilogram
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

teclistamab

PRD9936207 · Product

Active substance
Teclistamab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 µg/Kg microgram(s)/kilogram
Max total dose
0 µg/Kg microgram(s)/kilogram
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Fortecortin® 2 mg Tabletten

PRD10324901 · Product

Active substance
Dexamethasone
Substance synonyms
DEXAMETASONE, DEXAMETHASONUM
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
9587.01.00
MA holder
MERCK HEALTHCARE GERMANY GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Imnovid 3 mg hard capsules

PRD9260806 · Product

Active substance
Pomalidomide
Substance synonyms
CC-4047
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
L04AX06 — -
Marketing authorisation
EU/1/13/850/003
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/09/672
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Imnovid 1 mg hard capsules

PRD9260804 · Product

Active substance
Pomalidomide
Substance synonyms
CC-4047
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
L04AX06 — -
Marketing authorisation
EU/1/13/850/001
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/09/672
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Imnovid 4 mg hard capsules

PRD9260808 · Product

Active substance
Pomalidomide
Substance synonyms
CC-4047
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
L04AX06 — -
Marketing authorisation
EU/1/13/850/004
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/09/672
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Imnovid 2 mg hard capsules

PRD9260805 · Product

Active substance
Pomalidomide
Substance synonyms
CC-4047
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
L04AX06 — -
Marketing authorisation
EU/1/13/850/002
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/09/672
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Dexamethasone Tablets BP 2.0mg

PRD3570594 · Product

Active substance
Dexamethasone Ph. Eur.
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
PL 39699/0056
MA holder
ASPEN PHARMA TRADING LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Pomalidomide

PRD11001953 · Product

Active substance
Pomalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Pomalidomide

PRD11001952 · Product

Active substance
Pomalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Pomalidomide

PRD11001955 · Product

Active substance
Pomalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Pomalidomide

PRD11001954 · Product

Active substance
Pomalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Dexamethason 4 mg JENAPHARM®

PRD988426 · Product

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
40153.00.00
MA holder
MIBE GMBH ARZNEIMITTEL
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Dexamethason 8 mg GALEN® Tabletten

PRD808394 · Product

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
33652.01.00
MA holder
GALENPHARMA GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Auxiliary 3

Privigen 100 mg/ml solution for infusion

PRD339234 · Product

Active substance
Human Normal Immunoglobulin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
0 mg/Kg milligram(s)/kilogram
Max total dose
0 mg/Kg milligram(s)/kilogram
Max treatment duration
1 Month(s)
Authorisation status
Authorised
ATC code
J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
Marketing authorisation
EU/1/08/446/001
MA holder
CSL BEHRING GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Privigen 100 mg/ml solution for infusion

PRD339232 · Product

Active substance
Human Normal Immunoglobulin
Substance synonyms
IMMUNOGLOBULIN HUMAN NORMAL
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
0 mg/Kg milligram(s)/kilogram
Max total dose
0 mg/Kg milligram(s)/kilogram
Max treatment duration
1 Month(s)
Authorisation status
Authorised
ATC code
J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
Marketing authorisation
EU/1/08/446/003
MA holder
CSL BEHRING GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Privigen 100 mg/ml solution for infusion

PRD339233 · Product

Active substance
Human Normal Immunoglobulin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
0 mg/Kg milligram(s)/kilogram
Max total dose
0 mg/Kg milligram(s)/kilogram
Max treatment duration
1 Month(s)
Authorisation status
Authorised
ATC code
J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
Marketing authorisation
EU/1/08/446/002
MA holder
CSL BEHRING GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
repackaged and relabeled

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

109 Total trials 22 Recruiting 86 Ended
Commercial
Sponsor organisation
Janssen - Cilag International
Address
Turnhoutseweg 30
City
Beerse
Postcode
2340
Country
Belgium

Scientific contact point

Organisation
Janssen - Cilag International
Contact name
CTIS Point of Contact

Public contact point

Organisation
Janssen - Cilag International
Contact name
CTIS Point of Contact

Third parties 11

OrganisationCity, countryDuties
Hematogenix
ORG-100047219
 Cyberjaya, Malaysia Laboratory analysis
Labcorp Central Laboratory Services SARL
ORG-100011524
 Meyrin, Switzerland Laboratory analysis
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Adaptive Biotechnologies Corp.
ORG-100044428
 Seattle, United States Laboratory analysis
Labcorp Early Development Laboratories Inc.
ORG-100012865
 Indianapolis, United States Laboratory analysis
Yprime LLC
ORG-100042888
 Malvern, United States Other
Labcorp Development (Asia) Pte Ltd
ORG-100050418
 Singapore, Singapore Laboratory analysis
Hematogenix Laboratory Services LLC
ORG-100040020
 Tinley Park, United States Laboratory analysis
Hematogenix Laboratory Services Limited
ORG-100047188
 Cheadle, United Kingdom Laboratory analysis
Almac Clinical Services LLC
ORG-100041692
 Souderton, United States Interactive response technologies (IRT)
IQVIA RDS & Integrated Services Belgium
ORG-100030243
 Zaventem, Belgium On site monitoring, Code 12

Locations

10 EU/EEA countries · 72 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruitment ended 26 7
Denmark Ongoing, recruitment ended 10 5
France Ongoing, recruitment ended 37 10
Germany Ongoing, recruitment ended 34 8
Greece Ongoing, recruitment ended 18 3
Italy Ongoing, recruitment ended 30 5
Netherlands Ongoing, recruitment ended 23 5
Poland Ongoing, recruitment ended 28 7
Spain Ongoing, recruitment ended 80 15
Sweden Ongoing, recruitment ended 24 7
Rest of world
Canada, China, Turkey, Argentina, United States, Taiwan, Brazil, Japan, Korea, Republic of, United Kingdom
 — 219 —

Investigational sites

Belgium

7 sites · Ongoing, recruitment ended
Ziekenhuis Aan De Stroom
Hematologie, Kempenstraat 100, 2030, Antwerp
Algemeen Ziekenhuis Groeninge
Hematologie, President Kennedylaan 4, 8500, Kortrijk
Algemeen Ziekenhuis Delta
Hematologie, Deltalaan 1, 8800, Roeselare
UZ Leuven
Hematologie, Herestraat 49, 3000, Leuven
Az St-Jan Brugge-Oostende A.V.
Hematologie, Ruddershove 10, 8000, Brugge
CHU Helora
Hematology, Rue Ferrer 159 Boite 1, 7100, La Louviere
Universitair Ziekenhuis Gent
Hematologie, Corneel Heymanslaan 10, 9000, Gent

Denmark

5 sites · Ongoing, recruitment ended
Lillebaelt Hospital
Department Of Hematology Section of Internal Medicine, Beriderbakken 4, 7100, Vejle
Rigshospitalet
Department of Haematology, Blegdamsvej 9, 2100, Copenhagen Oe
Aalborg University Hospital
Department of Haematology, Moelleparkvej 4, 9000, Aalborg
Aarhus Universitetshospital
Blodsygdomme Klinisk Forskningsenhed, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
Haematologisk Forskningsenhed HFE-X, Kloevervaenget 47, 5000, Odense C

France

10 sites · Ongoing, recruitment ended
Centre Hospitalier Et Universitaire De Limoges
Hematology Department, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire De Toulouse
Hematology Department, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Lille
Blood Diseases Department, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire De Nantes
Hematology Department, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Poitiers
Hematology Department, 2 Rue De La Miletrie, 86000, Poitiers
Institut De Cancerologie Strasbourg Europe
Hematology Department, 17 Rue Albert Calmette, 67200, Strasbourg
Assistance Publique Hopitaux De Paris
Hematology Department, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Hospices Civils De Lyon
Hematology Department, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Regional Universitaire De Tours
Hematology Department, 2 Boulevard Tonnelle, 37000, Tours
Les Hopitaux Universitaires De Strasbourg
Oncology and Hematology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2

Germany

8 sites · Ongoing, recruitment ended
St. Barbara-Klinik Hamm GmbH
Hämatologie/Onkologie, Am Heessener Wald 1, Heessen, Hamm
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik und Poliklinik I, Hämatologische Ambulanz MK1-A1, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Leipzig AöR
Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitaetsklinikum Tuebingen AöR
Medizinische Klinik II (Myelomzentrum), Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Universitaetsklinikum Heidelberg AöR
Innere Medizin V (Hämatologie, Onkologie, Rheumatologie), Im Neuenheimer Feld 410, Neuenheim, Heidelberg
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Duesseldorf AöR
Klinik für Hämatologie, Onkologie und klinische Immunologie, Moorenstrasse 5, Bilk, Duesseldorf
Medical Center - University Of Freiburg
Innere Medizin I (Hämatologie, Onkologie), Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau

Greece

3 sites · Ongoing, recruitment ended
Alexandra Hospital
Therapeutic Clinic-Oncology Department of, General Hospital of Athens, Vassilissas Sofias Avenue 80, 115 28, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Department - Bone Marrow Transplantation Unit, Exochi, 570 10, Thessaloniki
Theageneio Cancer Hospital
Hematology Department, Simeonidi Alex 2, 546 39, Thessaloniki

Italy

5 sites · Ongoing, recruitment ended
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC Ematologia, Via Pietro Albertoni 15, 40138, Bologna
University Hospital Consorziale Policlinico
U.O. Ematologia con Trapianto, Piazza Giulio Cesare 11, 70124, Bari
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia, Via Piero Maroncelli 40, 47014, Meldola
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
SC Ematologia, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Oncologia, Corso Bramante 88, 10126, Turin

Netherlands

5 sites · Ongoing, recruitment ended
Universitair Medisch Centrum Groningen
Hematologie, Hanzeplein 1, 9713 GZ, Groningen
Stichting Amsterdam UMC
Hematologie, De Boelelaan 1117, 1081 HV, Amsterdam
Stichting Radboud universitair medisch centrum
Hematologie, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
St. Antonius Ziekenhuis
Hematologie, Koekoekslaan 1, 3435 CM, Nieuwegein
Isala Klinieken Stichting
Hematolgoie, Dokter Van Heesweg 2, 8025 AB, Zwolle

Poland

7 sites · Ongoing, recruitment ended
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Nowotworow 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
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworow Ukladu Chlonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Pratia Hematologia Sp. z o.o.
N/A, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddział Hematologii i Transplantacji Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Oddzial Hematologii, Ul. Alfreda Sokolowskiego 4, 58-309, Walbrzych

Spain

15 sites · Ongoing, recruitment ended
Hospital Universitario De Cabuenes
Hematology, Calle Prados 395, Cabuenes, Gijon
Hospital General Universitario Gregorio Maranon
Haematology and Hemotherapy - Bone Marrow Transplant Unit, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Quironsalud Madrid
Haematology and Hemotherapy, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Y Politecnico La Fe
Hematology and Hemotherapy, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
University Hospital Son Espases
Hematology, Carretera Valldemossa 79, 07120, Palma
Complexo Hospitalario Universitario De Santiago
Hematology, Calle Choupana Da S/n, 15706, Santiago De Compostela
University Hospital Virgen Del Rocio S.L.
Haematology and Hemotherapy, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario De Salamanca
Hematologia, Paseo De San Vicente 58-182, 37007, Salamanca
El Hospital Universitario De Gran Canaria Dr. Negrin
Hematology, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona

Sweden

7 sites · Ongoing, recruitment ended
Region Skane Skanes Universitetssjukhus
Hematologimottagning, Entregatan 7, 222 42, Lund
Region Dalarna
Medicinkliniken Hematologimottagningen, Vasagatan 27, Falu Kristine, Falun
Uppsala University Hospital
Hematologisk dagvård, Sjukhusvagen 85, 751 85, Uppsala
Region Vaesterbotten
Hematologisektionen, Koksvagen 11, Alidhem, Umea
Region Skane Helsingborg Hospital
Hematologimottagningen, Charlotte Yhlens Gata 10, Helsingborgs Maria, Helsingborg
Uppsala University Hospital
KFUE- Blod- och Tumörsjukdomar, Akademiska Sjukhuset, 751 85, Uppsala
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Hematologkliniken, Bruna Straket 16, 413 46, Gothenburg

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2021-10-14 2021-10-14 2022-11-29
Denmark 2022-03-11 2022-03-11 2022-12-09
France 2022-01-20 2022-01-20 2022-12-07
Germany 2022-04-11 2022-04-11 2022-12-07
Greece 2022-03-10 2022-03-10 2022-12-02
Italy 2022-04-13 2022-04-13 2023-01-13
Netherlands 2022-01-27 2022-01-27 2022-11-29
Poland 2022-07-05 2022-07-05 2022-12-07
Spain 2021-11-17 2021-11-17 2023-01-15
Sweden 2021-11-25 2021-11-25 2022-12-08

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 117 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_REDACTED Protocol 2023-503441-55 AM9
Protocol (for publication) D4_REDACTED PF Temperature Diary IT 2
Protocol (for publication) D4_REDACTED PF_EORTC QLQ-C30_EN 2
Protocol (for publication) D4_REDACTED PF_EQ-5D-5L_EN 2
Protocol (for publication) D4_REDACTED PF_MySlm-Q_MULTILINGUAL 2
Protocol (for publication) D4_REDACTED PF_PGI-S_MULTILINGUAL 2
Protocol (for publication) D4_REDACTED PF_PRO-CTCAE_MULTILINGUAL 2
Protocol (for publication) D4_REDACTED PF_PROMIS_EN 2
Protocol (for publication) D4_REDACTED PF_Temperature Diary_EN 1
Protocol (for publication) REDACTED_D4_PF Temperature Diary_BE_Dut_2023-503441-55 2
Protocol (for publication) REDACTED_D4_PF Temperature Diary_BE_Fre_2023-503441-55 2
Protocol (for publication) REDACTED_D4_PF Temperature Diary_DE_ger_64007957MMY3001 2
Protocol (for publication) REDACTED_D4_PF Temperature Diary_ES_SPA_2023-503441-55-00 1
Protocol (for publication) REDACTED_D4_PF Temperature Diary_NL_Dut_2023-503441-55 2
Protocol (for publication) REDACTED_D4_PF Temperature Diary_SE_swe_2023-503441-55 2
Protocol (for publication) REDACTED_D4_Temperature Diary_FR_fre_2023-503441-55 2
Protocol (for publication) REDACTED_D4_Temperature Diary_GR_GRE_64007957MMY3001 2
Recruitment arrangements (for publication) K1_Placeholder Recruitment arrangements_NL_Eng_2023-503441-55 1
Recruitment arrangements (for publication) K1_Placeholder_Recruitment Arrangements_DE_eng_64007957MMY3001 1
Recruitment arrangements (for publication) K1_PLACEHOLDER_Recruitment Arrangements_DK_eng_64007957MMY3001 1
Recruitment arrangements (for publication) K1_Placeholder_Recruitment arrangements_GR_EN_64007957MMY3001 1
Recruitment arrangements (for publication) K1_Placeholder_Recruitment Arrangements_IT_ENG_64007957MMY3001 1
Recruitment arrangements (for publication) K1_PLACEHOLDER_Recruitment Arrangements_SE_eng_64007957MMY3001 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_BE_Eng_2023-503441-55 1
Recruitment arrangements (for publication) Placeholder_K1_Recruitment Arrangements _FR_eng_2023-503441-55 1
Recruitment arrangements (for publication) PLACEHOLDER_K1_Recruitment Arrangements_ES_ENG_2023-503441-55 1
Recruitment arrangements (for publication) PLACEHOLDER_K1_Recruitment Arrangements_PL_ENG_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum 1_BE_Dut_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum 1_BE_Fre_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum 2_BE_Dut_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum 2_BE_Fre_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum 2_PL_POL_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum 3_BE_Dut_2023-503441-55 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum 3_BE_Fre_2023-503441-55 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum 4_BE_Dut_2023-503441-55 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum 4_BE_Fre_2023-503441-55 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF addendum_ES_SPA_2023-503441-55 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum_GR_GRE_2023-503441-55 6.1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum_PL_POL_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Addendum_SE_swe_2023-503441-55 6
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Clinical_DE_ger_2023-503441-55 11
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Clinical_DK_dan_2023-503441-55 11
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Clinical_PL_POL_2023-503441-55 6
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Competent Adult_DK_dan_64007957MMY3001 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Main Addendum_BE_Dut_2023-503441-55 5
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Main Addendum_BE_Fre_2023-503441-55 5
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Main Addendum_NL_Dut_2023-503441-55 5
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Main Tec-Dara Cohort_GR_GRE_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master 7_SE_Swe_64007957MMY3001 7
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master Addendum 1_ES_SPA_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master Addendum 2_ES_SPA_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master Addendum 3_ES_SPA_2023-503441-55 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master_ES_SPA_2023-503441-55 5
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Optional Future Research_DK_dan_64007957MMY3001 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_DE_ger_64007957MMY3001 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_DK_dan_64007957MMY3001 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_ES_SPA_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_PL_POL_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Pregnant Partner_SE_swe_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Privacy_IT_ita_2023-503441-55 8
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Withdrawal_DE_ger_64007957MMY3001 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Withdrawal_ES_SPA_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Withdrawal_PL_POL_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Addendum 1_NL_Dut_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Addendum 2_NL_Dut_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Addendum 3_1_NL_Dut_2023-503441-55 3.1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Addendum 4_NL_Dut_2023-503441-55 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_BE_Dut_2023-503441-55 4.1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_BE_Fre_2023-503441-55 4.1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Clinical ICF_IT_ITA_64007957MMY3001 8
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Main_FR_fre_2023-503441-55 16
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Main_NL_Dut_2023-503441-55 4.2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Pregnant Partner_FR_fre_2023-503441-55 3
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Pregnant Partner_IT_ITA_64007957MMY3001 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Withdrawal_FR_fre_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF_Withdrawal_IT_ITA_64007957MMY3001 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and Main Addendum ICF_GR_GRE_64007957MMY3001 5
Subject information and informed consent form (for publication) REDACTED_L1_SIS and Main ICF_GR_GRE_64007957MMY3001 8.1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and Pregnant Partner ICF_GR_GRE_64007957MMY3001 1.1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and Withdrawal ICF_GR_GRE_64007957MMY3001 1.2
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card Arm A_BE_Dut_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card Arm A_BE_Fre_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card Arm A_DE_ger_64007957MMY3001 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card Arm A_DK_Dan_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card Arm A_PL_POL_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card Arm B_BE_Dut_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card Arm B_BE_Fre_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card Arm B_DE_ger_64007957MMY3001 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card Arm B_DK_Dan_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card Arm B_PL_POL_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card ArmA_GR_gre_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card ArmB_GR_gre_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_Arm A_SE_swe_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_Arm A_TeC-DARA_FR_fre_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_Arm A&B_FR_FRE_2023-503441-55 3
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_Arm B DPd_SE_swe_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_Arm B DVd_SE_swe_2023-503441-55 2
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_Arm B_DPd-DVd_FR_fre_2023-503441-55 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_Group A_IT_ITA_64007957MMY3001 2
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_Group B_IT_ITA_64007957MMY3001 2
Summary of Product Characteristics (SmPC) (for publication) E2_AuPI pomalidomide 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC bortezomib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC dexamethasone 2mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC dexamethasone 4mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC dexamethasone 8mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC dexamethasone Merck 2mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC pomalidomide 1
Synopsis of the protocol (for publication) REDACTED_D1_ Protocol Synopsis_PL_POL_2023-503441-55 Am9
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis SE_swe_2023-503441-55 Am9
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis_BE_Dut_2023-503441-55 Am9
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis_BE_Fre_2023-503441-55 Am9
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis_BE_Ger_2023-503441-55 Am9
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_ES_SPA_2023-503441-55 Am9
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_FR_FRE_2023-503441-55 Am9
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_GR_GRE_2023-503441-55 Am9
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_IT_ITA_2023-503441-55 Am9
Synopsis of the protocol (for publication) REDACTED_D1_Protocol synopsis_NL_Dut_2023-503441-55 Am9

Application history

7 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-05-30 France Acceptable
2024-07-15
 2024-07-16
2 SUBSTANTIAL MODIFICATION SM-1 2024-09-25 Acceptable 2024-11-06
3 SUBSTANTIAL MODIFICATION SM-2 2024-11-26 France Acceptable
2025-02-05
 2025-02-06
4 SUBSTANTIAL MODIFICATION SM-3 2025-03-25 France Acceptable
2025-05-26
 2025-05-27
5 NON SUBSTANTIAL MODIFICATION NSM-1 2025-07-09 Acceptable
2025-05-26
 2025-07-09
6 SUBSTANTIAL MODIFICATION SM-4 2025-07-21 France Acceptable
2025-09-22
 2025-09-22
7 SUBSTANTIAL MODIFICATION SM-5 2025-11-11 France Acceptable
2026-03-02
 2026-03-02

Related clinical trials