Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
508
Countries
6
Sites
37
Relapsed or Refractory Multiple Myeloma
Arm A and Arm B Primary Objective 1: To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM. Primary Objective 2: To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negat…
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-05-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- AstraZeneca
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacodynamic, Safety, Efficacy, Others
Arm A and Arm B
Primary Objective 1: To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM.
Primary Objective 2: To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negative CR rate at 9 months in participants with RRMM.
Secondary objectives 2
- Arm A and Arm B: Efficacy: To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, orKd) by assessment of CRR, ORR, and OS in participantswith RRMM. Also to evaluate additional efficacy parameters of AZD0120 compared with those of standard therapy (DKd, DPd, PVd, or Kd) in participants with RRMM.
- Arm A and Arm B: Safety: To evaluate the safety of AZD0120 as compared with that of standard therapy (DKd, DPd, PVd, or Kd) inparticipants with RRMM.
Conditions and MedDRA coding
Relapsed or Refractory Multiple Myeloma
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Arm A and B: Participants must be 18 years or older, at the time of signing the ICF.
- Arm A and B: Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
- Arm A and B: Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c) Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio.
- Arm A and B: Participant must have documented evidence of PD by IMWG 2016 criteria based on Investigator’s determination during or after the most recent line of therapy. Participants who have had only 1 prior line of therapy must have disease that has progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy.
- Arm A and B: Participant must have received 1 to 3 lines of prior therapy including an IMiD and either a PI or an anti-CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy.
- Arm A and B: Participant is eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.
- Arm A and B: Participants must have an ECOG performance status score of 0 to 1.
- Arm A and B: Adequate organ and bone marrow function.
Exclusion criteria 9
- Arm A and B: Participant has active or prior CNS or meningeal involvement of MM.
- Arm A and B: Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
- Arm A and B: Participant has primary refractory MM (no minimal response to any prior therapy).
- Arm A and B: Participant has significant neurological or psychiatric condition posing risk or impairing evaluation (e.g., severe brain injury, dementia, Parkinson’s, stroke, intracranial hemorrhage, or seizure within 6 months). Stable mild conditions may be eligible at Investigator discretion.
- Arm A and B: Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation, including: -Serious active or uncontrolled infection, -Requirement of supplemental oxygen, -Active autoimmune disease or history within 2 years, -Clinically significant gastrointestinal disease (including IBD requiring treatment within 5 years).
- Arm A and B: Participant previously received any BCMA-targeted treatment.
- Arm A and B: Participant previously received CAR-T or CAR-NK therapy.
- Arm A and B: Participant previously received T-cell engager therapy.
- Arm A and B: Participant previously received allogeneic stem cell transplant at any time or ASCT within 12 weeks before randomization.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Arm A and B: PFS: defined as the time from the randomisation until the date of documented disease progression according to IMWG 2016 criteria as assessed by BICR or death due to any cause, whichever occurs first.
- Arm A and B: MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
Secondary endpoints 10
- Arm A and B: OS: defined as time from randomisation until date of death due to any cause
- Arm A and B: CRR (CR/sCR rate): defined as the proportion of participants who achieved a best response of CR or better according to IMWG 2016 criteria, as assessed by BICR.
- Arm A and B: ORR: defined as the proportion of participants who achieved PR or better according to IMWG 2016 criteria, as assessed by BICR.
- Arm A and B: DoR: defined as the time from first documented confirmed response until date of documented PD per IMWG2016 criteria or death due to any cause, whichever occurs first.
- Arm A and B: TTR: defined as the time from randomisation until the date of first documented objective response, as assessed per IMWG 2016 criteria.
- Arm A and B: MRD negative CR rate: defined as the proportion of participants who have MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at any time after the date of randomisation and before initiation of subsequent therapy.
- Arm A and B: Rate of sustained MRD negative CR: defined as the proportion of participants who have achieved MRD negative status and have a response of CR or sCR, confirmed minimum 1 year apart without any examination showing MRD positive status in between status assessments.
- Arm A and B: PFS-2: defined as the time from randomisation to progression on next line of therapy, as assessed by Investigator or death due to any cause.
- Arm A and B: TFI: defined as the time from last dose of study intervention to the date of the first dose of subsequent anti-myeloma therapy.
- Arm A and B: Safety will be evaluated in terms of AEs, vital signs, and clinical laboratory results.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12567222 · Product
- Active substance
- AZD0120
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 U unit(s)
- Max total dose
- 0 U unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 13
Pomalidomide Zentiva 2 mg hard capsules
PRD11486346 · 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 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/24/1830/007
- MA holder
- ZENTIVA, K.S.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pomalidomide Zentiva 4 mg hard capsules
PRD11486794 · 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 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/24/1830/015
- MA holder
- ZENTIVA, K.S.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pomalidomide Zentiva 3 mg hard capsules
PRD11486422 · 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 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/24/1830/011
- MA holder
- ZENTIVA, K.S.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pomalidomide Zentiva 1 mg hard capsules
PRD11486291 · 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 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/24/1830/003
- MA holder
- ZENTIVA, K.S.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DARZALEX 1800 mg solution for injection
PRD8157846 · Product
- Active substance
- Daratumumab
- Substance synonyms
- HuMax-CD38
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(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/3/18/2020
- Modified vs. Marketing Authorisation
- No
Bortezomib Hikma 3,5 mg Pulver zur Herstellung einer Injektionslösung
PRD7544921 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XX32 — -
- Marketing authorisation
- 2203180.00.00
- MA holder
- HIKMA PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethason 1,5 mg JENAPHARM®
PRD12104481 · 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 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 40153.01.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethason 0,5 mg JENAPHARM®
PRD12104038 · 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 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 3000402.00.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD12104334 · 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 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 40153.02.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD12104317 · 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 Day(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
- No
Kyprolis 30 mg powder for solution for infusion
PRD4301210 · Product
- Active substance
- Carfilzomib
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XG02 — -
- Marketing authorisation
- EU/1/15/1060/003
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/548
- Modified vs. Marketing Authorisation
- No
Kyprolis 10 mg powder for solution for infusion
PRD4301209 · Product
- Active substance
- Carfilzomib
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XG02 — -
- Marketing authorisation
- EU/1/15/1060/002
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/548
- Modified vs. Marketing Authorisation
- No
Kyprolis 60 mg powder for solution for infusion
PRD3374183 · Product
- Active substance
- Carfilzomib
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XG02 — -
- Marketing authorisation
- EU/1/15/1060/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/548
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
6 EU/EEA countries · 37 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 17 | 6 |
| Germany | Authorised, recruitment pending | 29 | 10 |
| Italy | Authorised, recruitment pending | 25 | 6 |
| Norway | Authorised, recruitment pending | 9 | 1 |
| Poland | Authorised, recruitment pending | 29 | 6 |
| Spain | Authorised, recruitment pending | 44 | 8 |
| Rest of world
Australia, Japan, Brazil, China, United States, Korea, Republic of, Taiwan, Canada, United Kingdom
|
— | 355 | — |
Investigational sites
Hospices Civils De Lyon
Hematology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Lille
Service des maladies du sang, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire De Toulouse
Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Nantes
Clinical Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Poitiers
Pôle régional de cancérologie, 2 Rue De La Miletrie, 86000, Poitiers
Hopital Saint Louis
Immunology - Hematology, 1 Avenue Claude Vellefaux, 75010, Paris
University Medical Center Hamburg-Eppendorf
Zentrum für Onkologie, II. Medizinischen Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
III. Med. Klinik u. Poliklinik Hämatologie u. Med. Onkologie, Langenbeckstrasse 1, Oberstadt, Mainz
Technische Universitaet Dresden
Med. Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Medical Center - University Of Freiburg
Klinik f. Innere Medizin I Hämatologie, Onkologie u. Stammzellentransplantation, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Wuerzburg AöR
Med. Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 5 – Hämatologie und Internistische Onkologie, Ulmenweg 18, Innenstadt, Erlangen
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CBF), Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Essen AöR
Klinik f. Hämatologie u. Stammzellentransplantation, Hufelandstrasse 55, Holsterhausen, Essen
Klinikum Nuernberg
Universitätsklinik f. Innere Medizin 5 – Onkologie und Hämatologie, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Universitaet Leipzig
Klinik u. Poliklinik f. Hämatologie, Zelltherapie, Hämostaseologie u. Infektiologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Fondazione IRCCS Istituto Nazionale Dei Tumori
Dipartimento di Oncologia ed Emato-Oncologia, Via Giacomo Venezian 1, 20133, Milan
Ospedale San Raffaele S.r.l.
U. O. di Ematologia e Trapianto Midollo Osseo (UTMO), Via Olgettina 60, 20132, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SC Ematologia Oncologica e Trapianto di Cellule Staminali, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattie Oncologiche ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Hematology U Division/Department of "Biotecnologie Molecolari e Scienze per la Salute", Corso Bramante 88, 10126, Turin
Humanitas Mirasole S.p.A.
U.O. Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Transplantacji Szpiku i Onkohematologii, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddzial Hematologii i Transplantacji Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul. Indiry Gandhi 14, 02-776, Warsaw
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddzial Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Clinica Universidad De Navarra
Hematology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
Hematology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario 12 De Octubre
Hematology, Avenida De Cordoba Sn, 28041, Madrid
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 42 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-523285-25-00_redacted | EU v1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NO | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult Participant_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult PL_Exceptional Release Product_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Exceptional Release_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Exceptional Release_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adults_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Genetic_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional genomic PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner PL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partners | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Study ICF Pregnant Partners_Clean | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Study ICF_Redacted | 2.0ES2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Study Subject Master Exceptional Release ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Apendice 1 ICF Adultos_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Birth | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Exceptional Release_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future research_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Multi-omics research_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genomics ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC _Bortezomib | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC _Carfilzomib | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC _Daratumumab | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC _Dexamethasone | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC _Pomalidomide | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2025-523285-25-00_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_LLS_ES_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_LLS_IT_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_LLS_PL_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_LLS_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NO_Norwegian_2025-523285-25-00_redacted | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-18 | Germany | Acceptable with conditions 2026-04-27
|
2026-04-30 |