Clinical trial • Phase III • Oncology

AZD0120 for Relapsed or refractory multiple myeloma

Phase III trial of AZD0120 for Relapsed or refractory multiple myeloma.

Overview

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

Key dates

Initial CTIS Submission Date
18-12-2025
First CTIS Authorization Date
30-04-2026

Trial design

Randomised, open-label, standard therapy regimens (dkd, dpd, pvd, or kd) as determined by investigator. comparator products listed in the dossier: darzalex (daratumumab) 1800 mg solution for injection; kyprolis (carfilzomib) powder for solution for infusion (10 mg, 30 mg, 60 mg presentations); pomalidomide zentiva (1 mg, 2 mg, 3 mg, 4 mg hard capsules); bortezomib hikma 3.5 mg powder for injection; dexamethason (0.5 mg, 1.5 mg, 4 mg, 8 mg tablets). dose schedules not specified in the ctis metadata.-controlled Phase III trial in France, Germany, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Standard therapy regimens (DKd, DPd, PVd, or Kd) as determined by Investigator. Comparator products listed in the dossier: DARZALEX (daratumumab) 1800 mg solution for injection; Kyprolis (carfilzomib) powder for solution for infusion (10 mg, 30 mg, 60 mg presentations); Pomalidomide Zentiva (1 mg, 2 mg, 3 mg, 4 mg hard capsules); Bortezomib Hikma 3.5 mg powder for injection; Dexamethason (0.5 mg, 1.5 mg, 4 mg, 8 mg tablets). Dose schedules not specified in the CTIS metadata.
Target Sample Size
355

Eligibility

Recruits 355 Participants must be 18 years or older; vulnerable population not selected (isVulnerablePopulationSelected=false). Informed consent is required from the adult participant. Country-specific subject information and informed consent forms (adult ICFs, pregnant partner ICF, optional genomics ICFs) were provided in the application documents; no paediatric assent procedures are specified..

Vulnerable Population
Participants must be 18 years or older; vulnerable population not selected (isVulnerablePopulationSelected=false). Informed consent is required from the adult participant. Country-specific subject information and informed consent forms (adult ICFs, pregnant partner ICF, optional genomics ICFs) were provided in the application documents; no paediatric assent procedures are specified.

Inclusion criteria

  • {"criterion_text":"- Arm A and B: Participants must be 18 years or older, at the time of signing the ICF."}
  • {"criterion_text":"- Arm A and B: Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Arm A and B: Participants must have an ECOG performance status score of 0 to 1."}
  • {"criterion_text":"- Arm A and B: Adequate organ and bone marrow function."}

Exclusion criteria

  • {"criterion_text":"- Arm A and B: Participant has active or prior CNS or meningeal involvement of MM."}
  • {"criterion_text":"- Arm A and B: Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome."}
  • {"criterion_text":"- Arm A and B: Participant has primary refractory MM (no minimal response to any prior therapy)."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- Arm A and B: Participant previously received any BCMA-targeted treatment."}
  • {"criterion_text":"- Arm A and B: Participant previously received CAR-T or CAR-NK therapy."}
  • {"criterion_text":"- Arm A and B: Participant previously received T-cell engager therapy."}
  • {"criterion_text":"- Arm A and B: Participant previously received allogeneic stem cell transplant at any time or ASCT within 12 weeks before randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Time from randomisation to documented disease progression per IMWG 2016 criteria as assessed by blinded independent central review (BICR) or death from any cause; whichever occurs first."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion of participants who are MRD negative and have CR or sCR per IMWG 2016 at 9 months (±3 months) from randomisation, prior to start of subsequent anti-myeloma therapy."}

Secondary endpoints

  • {"endpoint_text":"- Arm A and B: OS: defined as time from randomisation until date of death due to any cause","definition_or_measurement_approach":"Time from randomisation to death from any cause."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion achieving best response of CR or sCR per IMWG 2016 assessed by BICR."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion achieving PR or better per IMWG 2016 assessed by BICR."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Time from first documented confirmed response to documented progression per IMWG 2016 or death, whichever occurs first."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Time from randomisation to first documented objective response per IMWG 2016."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion with MRD negative status and CR or sCR at any time after randomisation and before subsequent therapy, per IMWG 2016."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion achieving MRD negative CR or sCR confirmed at least 1 year apart with no interim MRD positive assessments."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Time from randomisation to progression on next line of therapy per investigator assessment or death from any cause."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Time from last study intervention dose to first dose of subsequent anti-myeloma therapy."}
  • {"endpoint_text":"- Arm A and B: Safety will be evaluated in terms of AEs, vital signs, and clinical laboratory results.","definition_or_measurement_approach":"Safety assessed by adverse events, vital signs, and clinical laboratory results."}

Other endpoints

  • {"endpoint_text":"- immunogenicity, patient-reported outcomes, biomarkers of response&resistance,health care utilization","definition_or_measurement_approach":"Exploratory assessments including immunogenicity, patient-reported outcomes, biomarkers of response and resistance, and health-care utilisation (as listed in trial scope/secondary objectives)."}

Recruitment

Planned Sample Size
355
Recruitment Window Months
50
Consent Approach
Informed consent is required from participants (participants must be 18 years or older). Subject information and informed consent form documents were submitted (country-specific adult ICFs, pregnant partner ICFs, optional genomics ICFs). Consent is provided by the adult participant; no paediatric assent procedures are specified in the application metadata.

Geography

Total Number Of Sites
37
Total Number Of Participants
153

France

Earliest CTIS Part Ii Submission Date
25-02-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
68
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinical Hematology
Principal Investigator Name
Cyrille Touzeau
Principal Investigator Email
cyrille.touzeau@chu-nantes.fr
Contact Person Name
Cyrille Touzeau
Contact Person Email
cyrille.touzeau@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service des maladies du sang
Principal Investigator Name
Salomon Manier
Principal Investigator Email
salomon.manier@chru-lille.fr
Contact Person Name
Salomon Manier
Contact Person Email
salomon.manier@chru-lille.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hematology
Principal Investigator Name
Aurore Perrot
Principal Investigator Email
perrot.aurore@iuct-oncopole.fr
Contact Person Name
Aurore Perrot
Contact Person Email
perrot.aurore@iuct-oncopole.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Pôle régional de cancérologie
Principal Investigator Name
Xavier Leleu
Principal Investigator Email
xavier.leleu@chu-poitiers.fr
Contact Person Name
Xavier Leleu
Contact Person Email
xavier.leleu@chu-poitiers.fr
Site Name
Hospices Civils De Lyon
Department Name
Hematology
Principal Investigator Name
Lionel Karlin
Principal Investigator Email
lionel.karlin@chu-lyon.fr
Contact Person Name
Lionel Karlin
Contact Person Email
lionel.karlin@chu-lyon.fr
Site Name
Hopital Saint Louis
Department Name
Immunology - Hematology
Principal Investigator Name
Bertrand Arnulf
Principal Investigator Email
bertrand.arnulf@sls.aphp.fr
Contact Person Name
Bertrand Arnulf
Contact Person Email
bertrand.arnulf@sls.aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
13-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
21
Number Of Sites
9
Number Of Participants
29

Sites

Site Name
Universitaet Leipzig
Department Name
Klinik u. Poliklinik f. Hämatologie, Zelltherapie, Hämostaseologie u. Infektiologie
Principal Investigator Name
Vladan Vucinic
Principal Investigator Email
Vladan.Vucinic@medizin.uni-leipzig.de
Contact Person Name
Vladan Vucinic
Site Name
Technische Universitaet Dresden
Department Name
Med. Klinik und Poliklinik I
Principal Investigator Name
Raphael Teipel
Principal Investigator Email
raphael.teipel@ukdd.de
Contact Person Name
Raphael Teipel
Contact Person Email
raphael.teipel@ukdd.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Med. Klinik u. Poliklinik Hämatologie u. Med. Onkologie
Principal Investigator Name
Eva-Maria Wagner-Drouet
Principal Investigator Email
eva.wagner@unimedizin-mainz.de
Contact Person Name
Eva-Maria Wagner-Drouet
Contact Person Email
eva.wagner@unimedizin-mainz.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medizinische Klinik 5 – Hämatologie und Internistische Onkologie
Principal Investigator Name
Barbara Ferstl
Principal Investigator Email
barbara.ferstl@uk-erlangen.de
Contact Person Name
Barbara Ferstl
Contact Person Email
barbara.ferstl@uk-erlangen.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik f. Innere Medizin I Hämatologie, Onkologie u. Stammzellentransplantation
Principal Investigator Name
Ralph Wäsch
Principal Investigator Email
ralph.waesch@uniklinik-freiburg.de
Contact Person Name
Ralph Wäsch
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik f. Hämatologie u. Stammzellentransplantation
Principal Investigator Name
Bastian von Treschkow
Principal Investigator Email
bastian.vontresckow@uk-essen.de
Contact Person Name
Bastian von Treschkow
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Med. Klinik und Poliklinik II
Principal Investigator Name
Martin Kortüm
Principal Investigator Email
kortuem_m@ukw.de
Contact Person Name
Martin Kortüm
Contact Person Email
kortuem_m@ukw.de
Site Name
Klinikum Nuernberg
Department Name
Universitätsklinik f. Innere Medizin 5 – Onkologie und Hämatologie
Principal Investigator Name
Stefan Knop
Principal Investigator Email
stefan.knop@klinikum-nuernberg.de
Contact Person Name
Stefan Knop
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CBF)
Principal Investigator Name
Stephan Bohl
Principal Investigator Email
stephan.bohl@charite.de
Contact Person Name
Stephan Bohl
Contact Person Email
stephan.bohl@charite.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum für Onkologie, II. Medizinischen Klinik und Poliklinik
Principal Investigator Name
Katja Weisel
Principal Investigator Email
k.weisel@uke.de
Contact Person Name
Katja Weisel
Contact Person Email
k.weisel@uke.de

Italy

Earliest CTIS Part Ii Submission Date
31-03-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
34
Number Of Sites
6
Number Of Participants
25

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dipartimento di Oncologia ed Emato-Oncologia
Principal Investigator Name
Paolo Corradini
Principal Investigator Email
paolo.corradini@unimi.it
Contact Person Name
Paolo Corradini
Contact Person Email
paolo.corradini@unimi.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
SC Ematologia Oncologica e Trapianto di Cellule Staminali
Principal Investigator Name
Antonio Pinto
Principal Investigator Email
a.pinto@istitutotumori.na.it
Contact Person Name
Antonio Pinto
Contact Person Email
a.pinto@istitutotumori.na.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dipartimento Malattie Oncologiche ed Ematologiche
Principal Investigator Name
Elena Zamagni
Principal Investigator Email
e.zamagni@unibo.it
Contact Person Name
Elena Zamagni
Contact Person Email
e.zamagni@unibo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
U. O. di Ematologia e Trapianto Midollo Osseo (UTMO)
Principal Investigator Name
Fabio Ciceri
Principal Investigator Email
ciceri.clinicaltrials@hsr.it
Contact Person Name
Fabio Ciceri
Contact Person Email
ciceri.clinicaltrials@hsr.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Hematology U Division/Department of "Biotecnologie Molecolari e Scienze per la Salute"
Principal Investigator Name
Francesca Gay
Principal Investigator Email
francesca.gay@unito.it
Contact Person Name
Francesca Gay
Contact Person Email
francesca.gay@unito.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Oncologia Medica ed Ematologia
Principal Investigator Name
Armando Santoro
Principal Investigator Email
armando.santoro@cancercenter.humanitas.it
Contact Person Name
Armando Santoro

Spain

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
39
Number Of Sites
8
Number Of Participants
44

Sites

Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Maria Victoria Mateos
Principal Investigator Email
mvmateos@usal.es
Contact Person Name
Maria Victoria Mateos
Contact Person Email
mvmateos@usal.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Hematology
Principal Investigator Name
Paula Rodriguez Otero
Principal Investigator Email
paurodriguez@unav.es
Contact Person Name
Paula Rodriguez Otero
Contact Person Email
paurodriguez@unav.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Javier de la Rubia Comos
Principal Investigator Email
delarubia_jav@gva.es
Contact Person Name
Javier de la Rubia Comos
Contact Person Email
delarubia_jav@gva.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Hematology
Principal Investigator Name
Paula Rodriguez Otero
Principal Investigator Email
paurodriguez@unav.es
Contact Person Name
Paula Rodriguez Otero
Contact Person Email
paurodriguez@unav.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Principal Investigator Name
Joaquin Martinez Lopez
Principal Investigator Email
jmarti01@med.ucm.es
Contact Person Name
Joaquin Martinez Lopez
Contact Person Email
jmarti01@med.ucm.es
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Principal Investigator Name
Carlos Fernandez de Larrea
Principal Investigator Email
CFERNAN1@clinic.cat
Contact Person Name
Carlos Fernandez de Larrea
Contact Person Email
CFERNAN1@clinic.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Principal Investigator Name
Enrique Ocio San Miguel
Principal Investigator Email
ocioem@unican.es
Contact Person Name
Enrique Ocio San Miguel
Contact Person Email
ocioem@unican.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Mercedes Gironella Mesa
Principal Investigator Email
mgironella@vhio.net
Contact Person Name
Mercedes Gironella Mesa
Contact Person Email
mgironella@vhio.net

Norway

Earliest CTIS Part Ii Submission Date
17-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
13
Number Of Sites
1
Number Of Participants
9

Sites

Site Name
Oslo Universitetssykehus HF
Department Name
Department of Hematology
Principal Investigator Name
Ingerid Abrahamsen
Principal Investigator Email
inabra@ous-hf.no
Contact Person Name
Ingerid Abrahamsen
Contact Person Email
inabra@ous-hf.no

Poland

Earliest CTIS Part Ii Submission Date
14-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
16
Number Of Sites
7
Number Of Participants
29

Sites

Site Name
Instytut Hematologii I Transfuzjologii
Department Name
Klinika Hematologii
Principal Investigator Name
Ewa Lech-Maranda
Principal Investigator Email
emaranda@ihit.waw.pl
Contact Person Name
Ewa Lech-Maranda
Contact Person Email
emaranda@ihit.waw.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddzial Hematologii i Transplantacji Szpiku
Principal Investigator Name
Dominik Dytfeld
Principal Investigator Email
dytfeld@me.com
Contact Person Name
Dominik Dytfeld
Contact Person Email
dytfeld@me.com
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych
Principal Investigator Name
Tomasz Wrobel
Principal Investigator Email
tomasz.wrobel@umed.wroc.pl
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz.wrobel@umed.wroc.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Transplantacji Szpiku i Onkohematologii
Principal Investigator Name
Sebastian Giebel
Principal Investigator Email
sebastian.giebel@gliwice.nio.gov.pl
Contact Person Name
Sebastian Giebel
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Jan Zaucha
Principal Investigator Email
hematologia@uck.gda.pl
Contact Person Name
Jan Zaucha
Contact Person Email
hematologia@uck.gda.pl
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
Oddzial Hematologii i Transplantacji Szpiku
Principal Investigator Name
Wojciech Legiec
Principal Investigator Email
legiec.wojciech@gmail.com
Contact Person Name
Wojciech Legiec
Contact Person Email
legiec.wojciech@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne (additional site entry)

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
AZD0120
Active Substance
AZD0120
Modality
Cell therapy
Routes Of Administration
Intravenous use
Route
Intravenous
Authorisation Status
prodAuthStatus 1 (as recorded in product dictionary)

Related trials

Other published trials that may interest you.