Phase 3 Study to Evaluate Mezigdomide (CC-92480/BMS-986348) in Combination with Carfilzomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma: SUCCESSOR-2

Start 12 Jan 2023 · Status Ongoing, recruitment ended · 11 EU/EEA countries · 57 sites · Protocol CA057-008

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruitment ended

Participants planned 506

Countries 11

Sites 57

Relapsed or Refractory Multiple Myeloma (RRMM)

To compare the progression-free survival (PFS) of CC-92480, carfilzomib and dexamethasone (480Kd) to that of carfilzomib and dexamethasone (Kd) in participants with relapsed or refractory multiple myeloma (RRMM)

Key facts

Sponsor: Celgene Corp.
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: 12 Jan 2023 → ongoing
Decision date (initial): 2022-12-12
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Celgene corporation

External identifiers

EU CT number: 2022-500861-29-00
WHO UTN: U1111-1278-9775

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. additional Infromation regarding Bristol-Myers Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

Participant has documented diagnosis of multiple myeloma (MM) and measurable disease, defined as any of the following: a. M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or b. M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or, c. For participants without measurable disease in sPEP or uPEP: sFLC levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal κ/λ FLC ratio.
Participant has received at least 1 prior line of anti-myeloma therapy.
Participant must have received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody. For country-specific requirements, refer to Appendix12.
Participant achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.
Participant must have documented disease progression during or after their last anti-myeloma regimen.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.

Exclusion criteria 4

Participant who has had prior treatment with mezigdomide or carfilzomib.
Participant who has had any investigational agents within 28 days or 5 half-lives (whichever is shorter) of initiating study intervention.
Participant has previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of initiating study intervention.
Participant with known central nervous system (CNS) involvement with myeloma.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

PFS: Time from randomization to first documentation of progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma or death due to any cause, whichever occurs first.

Investigational products

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

Test 10

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 40 mg milligram(s)
Max total dose: 14240 mg milligram(s)
Max treatment duration: 82 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 40 mg milligram(s)
Max total dose: 14240 mg milligram(s)
Max treatment duration: 82 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 40 mg milligram(s)
Max total dose: 14240 mg milligram(s)
Max treatment duration: 82 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Kyprolis 60 mg powder for solution for infusion

PRD3374183 · Product

Active substance: Carfilzomib
Substance synonyms: PR-171
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENIOUS INFUSION
Max daily dose: 56 mg/m2 milligram(s)/sq. meter
Max total dose: 29832 mg/m2 milligram(s)/sq. meter
Max treatment duration: 82 Month(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

CC-92480

PRD9757438 · Product

Active substance: Mezigdomide
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 0.2 mg milligram(s)
Max total dose: 373.8 mg milligram(s)
Max treatment duration: 82 Month(s)
Authorisation status: Not Authorised
MA holder: CELGENE CORPORATION
Paediatric formulation: No
Orphan designation: No

CC-92480

PRD9757763 · Product

Active substance: Mezigdomide
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 1 mg milligram(s)
Max total dose: 1869 mg milligram(s)
Max treatment duration: 82 Month(s)
Authorisation status: Not Authorised
MA holder: CELGENE CORPORATION
Paediatric formulation: No
Orphan designation: No

CC-92480

PRD9852270 · Product

Active substance: Mezigdomide
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 0.4 mg milligram(s)
Max total dose: 747.6 mg milligram(s)
Max treatment duration: 82 Month(s)
Authorisation status: Not Authorised
MA holder: CELGENE CORPORATION
Paediatric formulation: No
Orphan designation: No

CC-92480

PRD9757642 · Product

Active substance: Mezigdomide
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 0.6 mg milligram(s)
Max total dose: 1121.4 mg milligram(s)
Max treatment duration: 82 Month(s)
Authorisation status: Not Authorised
MA holder: CELGENE CORPORATION
Paediatric formulation: No
Orphan designation: No

CC-92480

PRD9757716 · Product

Active substance: Mezigdomide
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 0.8 mg milligram(s)
Max total dose: 1495.2 mg milligram(s)
Max treatment duration: 82 Month(s)
Authorisation status: Not Authorised
MA holder: CELGENE CORPORATION
Paediatric formulation: No
Orphan designation: No

CC-92480

PRD9852263 · Product

Active substance: Mezigdomide
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 0.3 mg milligram(s)
Max total dose: 560.7 mg milligram(s)
Max treatment duration: 82 Month(s)
Authorisation status: Not Authorised
MA holder: CELGENE CORPORATION
Paediatric formulation: No
Orphan designation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celgene Corp.

Sponsor organisation: Celgene Corp.
Address: Route 206 And Province Line Road
City: Princeton
Postcode: 08543-4000
Country: United States

Scientific contact point

Organisation: Celgene Corp.
Contact name: GSM-CT

Public contact point

Organisation: Celgene Corp.
Contact name: GSM-CT

Third parties 21

Organisation	City, country	Duties
Perceptive Informatics Inc. ORG-100013171	Burlington, United States	Other
Cerba Research ORG-100042694	Gent, Belgium	Other, Laboratory analysis
Ampersand Biosciences LLC ORG-100053411	Lake Clear, United States	Other
Labcorp Central Laboratory Services S.a.r.l. ORG-100012849	Meyrin, Switzerland	Other, Laboratory analysis
Accenture Solutions Private Limited ORG-100032592	Chennai, India	Other, Data management
Frontage Laboratories (Shanghai) Co. Ltd. ORG-100047384	Shanghai, China	Other
Cellcarta Naperville LLC ORG-100042145	Naperville, United States	Other
Signant Health Global LLC ORG-100040604	Blue Bell, United States	Other
Omnitrace Corp. ORG-100045579	Palm Beach Gardens, United States	Other
Endpoint Clinical Inc. ORG-100040567	Wakefield, United States	Other, Interactive response technologies (IRT)
Cellcarta ORG-100039881	Antwerp, Belgium	Other
Labcorp Central Laboratories Services LP ORG-100032236	Indianapolis, United States	Laboratory analysis
Azenta Germany GmbH ORG-100039257	Griesheim, Germany	Other
Greenphire LLC ORG-100041621	King Of Prussia, United States	Other
LabCorp Development (Asia) Pte. Ltd. ORL-000001747	Singapore	Other
Icon (Lr) Limited ORG-100042612	Dublin 18, Ireland	Other, Laboratory analysis
Medidata Solutions Inc. ORG-100016256	New York, United States	Other, Data management
Iqvia Inc. ORG-100010622	Durham, United States	Code 10, Other
Q2 Solutions ORL-000000131	Livingston, United Kingdom	Other
Hematogenix Laboratory Services Limited ORG-100047188	Cheadle, United Kingdom	Other
Cerbact Asia Holdings Pte. Ltd. ORG-100055091	Taipei, Taiwan	Other

Locations

11 EU/EEA countries · 57 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Ongoing, recruitment ended	6	3
Bulgaria	Ongoing, recruitment ended	14	3
Denmark	Ongoing, recruitment ended	26	4
Germany	Ongoing, recruitment ended	30	13
Greece	Ongoing, recruitment ended	20	3
Hungary	Ongoing, recruitment ended	22	5
Italy	Ongoing, recruitment ended	21	8
Netherlands	Ongoing, recruitment ended	10	2
Norway	Ongoing, recruitment ended	30	3
Romania	Ongoing, recruitment ended	20	3
Spain	Ongoing, recruitment ended	39	10
Rest of world Brazil, Singapore, India, Canada, Argentina, China, Taiwan, Colombia, United States, United Kingdom, Hong Kong, Japan, Australia	—	268	—

Investigational sites

Austria

3 sites · Ongoing, recruitment ended

Ordensklinikum Linz GmbH

Interne 1 - Hämatologie mit Stammzelltransplantation, Hämostaseologie und medizinische Onkologie, Fadingerstraße 1, 4020, Linz

Medical University Of Vienna

Universitätsklinik für Innere Medizin I, Waehringer Guertel 18-20, Alsergrund, Vienna

Krankenhaus der Barmherzigen Schwestern Wien Betriebsgesellschaft mbH

Betriebsgesellschaft m.b.H., Stumpergasse 13, 1060, Vienna

Bulgaria

3 sites · Ongoing, recruitment ended

University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD

Clinic of Clinical Hematology-clinical hematology Level III, Department of Clinical Hematology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia

University Multiprofile Hospital For Active Treatment Saint Georgi EAD

Clinic of Clinical Hematology, Bulevard Vasil Aprilov 15a, 4002, Plovdiv

Acibadem City Clinic Tokuda University Hospital EAD

Clinic of Hematology, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya

Denmark

4 sites · Ongoing, recruitment ended

Odense University Hospital

Department of Hematology, J B Winsloews Vej 4, 5000, Odense C

Lillebaelt Hospital

Department of Hematology, Beriderbakken 4, 7100, Vejle

Zealand University Hospital

Department of Hematology, Sygehusvej 10, 4000, Roskilde

Aarhus University Hospital

Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Germany

13 sites · Ongoing, recruitment ended

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

Medizinische Klinik I, Hämatoonkologische Ambulanz, Fetscherstrasse 74, Johannstadt-Nord, Dresden

Charite Universitatsmedizin Berlin KöR

Medizinische Klinik mit Schwerpunkt Hämatologie,Onkologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin

Marien Hospital Duesseldorf GmbH

Onkologiezentrum, Rochusstrasse 2, Pempelfort, Duesseldorf

Haematologie und Onkologie Muenchen-Pasing MVZ GmbH

Hämatologie und Onkologie, Baeckerstrasse 4, Pasing-Obermenzing, Munich

Universitaetsklinikum Jena KöR

Klinik für Innere Medizin II Abt. Hämatologie / Onkologie, Am Klinikum 1, Lobeda, Jena

Onkologisches Studienzentrum am Raschplatz GbR

Studienzentrum, Rundestr. 10, 30161, Hannover

University Medical Centre Schleswig-Holstein

Klinik für Innere Medizin II, Arnold-Heller-Straße 3, Brunswik, Kiel

Universitaetsklinikum Wuerzburg AöR

Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg

Klinikum Nürnberg

Klinik für Innere Medizin 5, Schwerpunkt Onkologie / Hämatologie, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg

Heidelberg University Hospital AöR

Zentrum für Innere Medizin (Krehl Klinik), Im Neuenheimer Feld 410, Neuenheim, Heidelberg

University Of Leipzig

Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig

University Hospital Of Ulm AöR

Klinik für Innere Medizin III, Albert-Einstein-Allee 23, Eselsberg, Ulm

GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH

Hämatologie und Onkologie, Am Oelpfad 12, Hörde, Dortmund

Greece

3 sites · Ongoing, recruitment ended

Geniko Nosokomeio Thessalonikis George Papanikolaou

Department of Haematology- Haematopoietic Cell Transplantation Centre, Exochi, 570 10, Thessaloniki

General University Hospital Of Patras

Bone Marrow Transplantation Unit, Rio, 265 04, Patras

Alexandra Hospital

Plasma Cell Dyscrasias Unit Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens

Hungary

5 sites · Ongoing, recruitment ended

Semmelweis University

Department of Internal Medicine and Hematology, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII

University Of Pecs

I. Department of Internal Medicine, Ifjusag Utja 13, 7624, Pecs

University Of Debrecen

Department of Internal Medicine, Haematology, Nagyerdei Korut 98, 4032, Debrecen

Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

Haematology, Sostoi Ut 62, 4400, Nyiregyhaza

Semmelweis University

Department of Internal Medicine and Haematology, Szentkiralyi Utca 46, Kerulet, Budapest VIII

Italy

8 sites · Ongoing, recruitment ended

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

Hematology, Via Pietro Albertoni 15, 40138, Bologna

Humanitas Research Hospital

Hematology, Via Alessandro Manzoni 56, 20089, Rozzano

Azienda Ospedaliero Universitaria Pisana

Hematology, Via Roma 67, 56126, Pisa

Ospedale Vito Fazzi Lecce

Hematology, Piazza Filippo Muratore 1, 73100, Lecce

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori S.r.l.

Medical oncology, Via Piero Maroncelli 40, 47014, Meldola

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

U.O.C. Hematology, Via Francesco Sforza 28, 20122, Milan

Azienda Sanitaria Universitaria Friuli Centrale

Hematology, Via Pozzuolo 330, 33100, Udine

Azienda Ospedaliera Pugliese Ciaccio

Hematology, Via Vinicio Cortese 25, 88100, Catanzaro

Netherlands

2 sites · Ongoing, recruitment ended

Amphia Hospital

Haematology, Langendijk 75, 4819 EV, Breda

Medisch Spectrum Twente

Haematology, Koningsplein 1, 7512 KZ, Enschede

Norway

3 sites · Ongoing, recruitment ended

Helse Bergen HF

Department of Medicine, Jonas Lies vei 79, Jonas Lies Vei 65, 5021, Bergen

Oslo University Hospital Hf

Oslo Myeloma Center, Taarnbygget, Kirkeveien 166, Oslo

Stavanger University Hospital

Dep of blood and cancer diseases, Postboks 8100, 4068, Stavanger

Romania

3 sites · Ongoing, recruitment ended

Affidea Romania S.R.L.

Hematology, Soseaua Fundeni 258, 022328, Bucharest

Institutul Clinic Fundeni

Center for Hematology and Bone Marrow Transplantation, Soseaua Fundeni 258, 022328, Bucharest

Spitalul Clinic Judetean De Urgenta Sibiu

Hematology, Bulevardul Coposu Corneliu 2-4, 550245, Sibiu

Spain

10 sites · Ongoing, recruitment ended

Hospital Universitario Regional De Málaga

Hematology, Avenida De Carlos De Haya S/n, 29010, Malaga

Catalan Institute Of Oncology

Hematology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat

Hospital Universitari Germans Trias I Pujol

Hematology, Ctra. Canyet S/n, Edificio General 1a Planta, Badalona

Hospital Universitario La Paz

Hematology, Paseo Castellana 261, 28046, Madrid

Hospital Universitario Virgen De Las Nieves

Hematology, Avenida De Las Fuerzas Armadas 2, 18014, Granada

Hospital Universitari Vall D Hebron

Hematology, Passeig De La Vall D Hebron 119-129, 08035, Barcelona

Hospital General Universitario Gregorio Maranon

Hematology, Calle Del Doctor Esquerdo 46, 28009, Madrid

University Hospital Of Canary Islands

Hematology, Carretera De La Cuesta Taco S/n, Cuesta La, San Cristobal De La Laguna

Hospital Clinico Universitario De Valencia

Hematology, Avenida Blasco Ibanez 17, 46010, Valencia

Hospital Universitario Puerta De Hierro De Majadahonda

Hematology, Calle De Manuel De Falla 1, 28222, Majadahonda

Country notifications

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

Country	Trial start	Recruitment start	Recruitment end
Austria	2023-01-19	2023-02-13	2025-06-19
Bulgaria	2024-09-27	2024-11-19	2025-06-19
Denmark	2023-05-16	2023-07-25	2025-06-19
Germany	2023-01-16	2023-04-19	2025-11-11
Greece	2023-02-16	2023-02-22	2025-06-19
Hungary	2023-07-21	2023-07-27	2025-06-19
Italy	2023-01-12	2023-01-16	2025-06-19
Netherlands	2024-08-29	2024-09-02	2025-06-19
Norway	2023-04-13	2023-04-18	2025-06-19
Romania	2024-09-10	2024-11-02	2025-05-26
Spain	2023-01-16	2023-02-21	2025-06-19

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Unexpected event UE-64822

Event date: 2024-11-14
Date aware: 2024-11-14
Submission date: 2024-12-24
Member states affected: Austria, Denmark, Germany, Greece, Hungary, Italy, Spain, Netherlands, Norway, Bulgaria, Romania
Clinical procedures: N/A
Event description: At the Independent Data Monitoring Committee (IDMC) meeting held on 04-Nov-2024, the IDMC for Mezigdomide SUCCESSOR-1 and SUCCESSOR-2 studies reviewed the unblinded study data and recommended the 2 studies continue “as is.” Additionally, action items were received from IDMC on 14-Nov-2024; the IDMC recommended “mandated PJP prophylaxis use to prevent opportunistic infections” and “reiterated the importance of mandated use of GCSF for neutropenia as per current ASCO guidelines.”

Corrective measures 1 · Art. 77 CTR

Corrective measure CM-HU-0001

Member state: Hungary
Publication date: 2023-02-09
Type: 3
Reason: 7
Immediate action required: Yes
Justification: Minden betegbiztonságot és/vagy jogokat érintő változtatás lényeges módosításnak tekintendő. Ezeket az ETT KFEB mint ilyent kíván értékelni. A tájékoztatás utáni beleegyező nyilatkozat módosítását lényeges módosításként kell benyújtani.

Results and documents

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

Documents 119 files

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

Type	Title	Version
Protocol (for publication)	D1_Pregnancy Prevention Plan	06
Protocol (for publication)	D1_Protocol_EU CT 2022-500861-29_GR_Redacted	04
Protocol (for publication)	D4 Patient Facing Documents redacted GR	N/A
Protocol (for publication)	D4_AT_Ger_Patient facing documents_statement for licensed questionnaires	1
Protocol (for publication)	D4_DE_Ger_Patient facing documents_statement for licensed questionnaires	1
Protocol (for publication)	D4_IT_Patient facing documents_statement for licensed questionnaires	N/A
Protocol (for publication)	D4_Patient facing documents_statement for licensed questionnaires_ES	N/A
Protocol (for publication)	D4_Statement on validated questionnaires under licence_RO	1
Protocol (for publication)	D4_Statement on validated questionnaires under license_HU	1
Protocol (for publication)	IT D4_Patient facing documents_QLQ_MY20 IT	N/A
Protocol (for publication)	IT D4_Patient facing documents_QLQ-C30 ITA	N/A
Protocol (for publication)	NL D4_Patient facing documents_statement for licensed questionnaires	1
Protocol (for publication)	Protocol 2022-500861-29-00_EN Redacted	04
Protocol (for publication)	Protocol Administrative Letter Redacted	02
Recruitment arrangements (for publication)	K Recruitment arrangements IT	3
Recruitment arrangements (for publication)	K Recruitment arrangements IT_v4 Clean	4
Recruitment arrangements (for publication)	K Recruitment arrangements NL	1
Recruitment arrangements (for publication)	K1 Template recruitment arrangements	3.0
Recruitment arrangements (for publication)	K1_BMS_MMProgramLevel_PaidSearch_DEDE_Text	1
Recruitment arrangements (for publication)	K1_CA057-008 EU CTR_informedconsent_patientrecruitmentprocedure_DK	N/A
Recruitment arrangements (for publication)	K1_CA057-008_recruitment and informed consent procedure HU	1
Recruitment arrangements (for publication)	K1_CA057-008_template_recruitment arrangements AT	2
Recruitment arrangements (for publication)	K1_CA057-008_template_recruitment arrangements DE	5
Recruitment arrangements (for publication)	K1_CA057-008_template_recruitment arrangements ESP_Redacted	1
Recruitment arrangements (for publication)	K1_Multiple_Myeloma_Germany_DE _FINAL	1
Recruitment arrangements (for publication)	K1_Recruitment and IC procedure_NO_Unredacted	2
Recruitment arrangements (for publication)	K1_Recruitment arrangements	N/A
Recruitment arrangements (for publication)	K1_Recruitment Material_Patient Brochure_ESP	1
Recruitment arrangements (for publication)	K1_Reqruitment arrangements_BG	1
Recruitment arrangements (for publication)	K1_Reqruitment arrangements_BG_TC	2
Recruitment arrangements (for publication)	K2 Recruitment Material	2
Recruitment arrangements (for publication)	K2_Recruitment material_HCP Brochure_RO	3.0
Recruitment arrangements (for publication)	K2_Recruitment material_Patient Brochure_BG	3.0
Recruitment arrangements (for publication)	K2_Recruitment material_Patient Brochure_RO	3.0
Recruitment arrangements (for publication)	K2_Recruitment material_Poster_BG	1
Recruitment arrangements (for publication)	K2_Recruitment material_Poster_RO	1
Recruitment arrangements (for publication)	K2_Recruitment material_Study Visit Guide_BG	3.0
Recruitment arrangements (for publication)	K2_Recruitment material_Study Visit Guide_RO	3.0
Subject information and informed consent form (for publication)	CA057-008_Global PPP_Adult v1_05Jun2023_Italian_Redacted	2
Subject information and informed consent form (for publication)	Global PPP celmod-adult-global-pregnancy-prevention-program GR Redacted	5.0
Subject information and informed consent form (for publication)	L1 - 1 SIS and ICF Main_HU_Redacted	7.1
Subject information and informed consent form (for publication)	L1 - 2 SIS and ICF Pregnant PARTNER_HU_redacted	4
Subject information and informed consent form (for publication)	L1 - 3 SIS and ICF Pregnant PATIENT_HU_redacted	4
Subject information and informed consent form (for publication)	L1 - 4 PGX ICF_HU_redacted	4.1
Subject information and informed consent form (for publication)	L1 - 4 PGX SIS_HU_Redacted	4.1
Subject information and informed consent form (for publication)	L1 Greenphire_information sheet and consent form	1
Subject information and informed consent form (for publication)	L1 ICF for Pregnant Partner_Redacted	1.2
Subject information and informed consent form (for publication)	L1 ICF Pregnant Participant	2.0
Subject information and informed consent form (for publication)	L1 Information sheet and consent form travel reimbursement_institution	1
Subject information and informed consent form (for publication)	L1 Main subject information sheet and consent form Redacted	8
Subject information and informed consent form (for publication)	L1 Main subject information sheet and consent form Redacted NL	8.0
Subject information and informed consent form (for publication)	L1 Main subject information sheet and consent form_ES_ Redacted	9
Subject information and informed consent form (for publication)	L1 Optional Retten til ikke-viden IC	1
Subject information and informed consent form (for publication)	L1 Pregnant participant information sheet and consent form	1
Subject information and informed consent form (for publication)	L1 Pregnant participant information sheet and consent form	2
Subject information and informed consent form (for publication)	L1 Pregnant Participant information sheet and consent form	3
Subject information and informed consent form (for publication)	L1 Pregnant partner information sheet and consent form	1
Subject information and informed consent form (for publication)	L1 Pregnant partner information sheet and consent form	2
Subject information and informed consent form (for publication)	L1 Pregnant Partner information sheet and consent form	3
Subject information and informed consent form (for publication)	L1 SIS and ICF Main_nor_clean_Redacted	6
Subject information and informed consent form (for publication)	L1_ ICF Main_Final_Redacted	7
Subject information and informed consent form (for publication)	L1_ ICF Pregnant Participant_DK_Final	2.0
Subject information and informed consent form (for publication)	L1_ ICF Pregnant Partner_Final	2.0
Subject information and informed consent form (for publication)	L1_CA057-001_Pregnant Participant_Tracked_Changes	2
Subject information and informed consent form (for publication)	L1_CA057-001_Pregnant Partner_Tracked_Changes	2
Subject information and informed consent form (for publication)	L1_CA057-008 ICF Main_AT_Final_Redacted	8
Subject information and informed consent form (for publication)	L1_CA057-008 ICF Main_DE_Final_Redacted	8
Subject information and informed consent form (for publication)	L1_CA057-008 ICF Pregnant Participant_AT_Final	2
Subject information and informed consent form (for publication)	L1_CA057-008 ICF Pregnant Participant_DE_Final	2
Subject information and informed consent form (for publication)	L1_CA057-008_BG_ ICF Main_2.0 dated 08 Sep 2024_bg_clean	2.0
Subject information and informed consent form (for publication)	L1_CA057-008_BG_ Main ICF_V6_0_ 04Sep2024_en_TC	8.0
Subject information and informed consent form (for publication)	L1_CA057-008_ICF Pregnant Participant_AT_TC	2
Subject information and informed consent form (for publication)	L1_CA057-008_ICF Pregnant Partner_AT_Final	2
Subject information and informed consent form (for publication)	L1_CA057-008_ICF Pregnant Partner_DE_Final	2
Subject information and informed consent form (for publication)	L1_CA057-008_ICF_PregPartner_AT_TC	2
Subject information and informed consent form (for publication)	L1_CA057-008_site contact details_AT_redacted	2
Subject information and informed consent form (for publication)	L1_Global Protocol Informed Consent CA057-008 IC Main 16 Aug 2024 v7_en	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_BG_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_EN_Redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_GR_Redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF main_Redacted	4.1
Subject information and informed consent form (for publication)	L1_SIS and ICF pregnant participant	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Participant_BG	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Participant_EN	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF pregnant partner	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Partner_BG	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Partner_EN	2.0
Subject information and informed consent form (for publication)	L1-2 SIS and ICF Pregnant PARTNER_NO_Unredacted	2
Subject information and informed consent form (for publication)	L1-3 SIS and ICF Pregnant PATIENT_NO_Unredacted	2
Subject information and informed consent form (for publication)	L2 Other subject information material Successor-2 Study_Patient Brochure	2.0
Subject information and informed consent form (for publication)	L2 Other subject information Pregnancy Prevention Plan_clean_Redacted	6.0
Subject information and informed consent form (for publication)	L2 Patient Alert Card_HU_Redacted	2
Subject information and informed consent form (for publication)	L2_AT_Eng_Ger_Other subject information material description_PPP_Redacted	6
Subject information and informed consent form (for publication)	L2_DE_Eng_Ger_Other subject information material description_PPP_Redacted	6
Subject information and informed consent form (for publication)	L2_Other subject info material _PPP	6
Subject information and informed consent form (for publication)	L2_Other subject info material _PPP_HU_Redacted	6
Subject information and informed consent form (for publication)	L2_Other subject information material description_PPP_NL Redacted	6
Subject information and informed consent form (for publication)	L2_Other subject information material PPP_ES	6
Subject information and informed consent form (for publication)	L2_Other subject information material_Mezigdomide Global PPP Adult_BG	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Mezigdomide Global PPP Adult_EN	6.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Mezigdomide Global PPP Adult_RO	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC Carfilzomib	20
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC Dexamethasone Aspen IE	1
Summary of Product Characteristics (SmPC) (for publication)	SmPC Carfilzomib	20
Summary of Product Characteristics (SmPC) (for publication)	SmPC Carfilzomib	Rev21
Summary of Product Characteristics (SmPC) (for publication)	SmPC Dexamethasone Aspen IE	1
Summary of Product Characteristics (SmPC) (for publication)	SmPC Dexamethasone Aspen IE	1
Synopsis of the protocol (for publication)	D1 Protocol synopsis AT EU CT 2022-500861-29-00_Clean	5
Synopsis of the protocol (for publication)	D1 Protocol synopsis DE EU CT 2022-500861-29-00	5
Synopsis of the protocol (for publication)	D1 Protocol synopsis ES EU CT 2022-500861-29-00	5
Synopsis of the protocol (for publication)	D1 Protocol synopsis HU EU CT 2022-500861-29-00	5
Synopsis of the protocol (for publication)	D1 Protocol synopsis IT EU CT 2022-500861-29-00_Clean	5
Synopsis of the protocol (for publication)	D1 Protocol synopsis NL EU CT 2022-500861-29-00 Redacted	5.0
Synopsis of the protocol (for publication)	D1 Protocol synopsis NO EU CT 2022-500861-29-00	5
Synopsis of the protocol (for publication)	D1 Protocol synopsis_ENG 2022-500861-29-00_Clean	5.0
Synopsis of the protocol (for publication)	D1 Protocol synopsis_GR_EU CT 2022-500861-29-00	5
Synopsis of the protocol (for publication)	D1_Protocol synopsis NL EU CT number 2022-500861-29-00_NLD_TC	3
Synopsis of the protocol (for publication)	D1_Protocol synopsis_BG_EU CT 2022-500861-29_BG_clean	5.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_RO_EU CT 2022-500861-29	5

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2022-08-11	Germany	Acceptable 2022-12-05	2022-12-06
2	NON SUBSTANTIAL MODIFICATION	NSM-2	2022-12-20	Germany	Acceptable 2022-12-05	2022-12-20
3	SUBSEQUENT ADDITION OF MSC	APP-3	2022-12-21		Acceptable 2022-12-05	2023-03-01
4	SUBSTANTIAL MODIFICATION	SM-1	2023-03-16	Germany	Acceptable 2023-05-22	2023-05-22
5	SUBSTANTIAL MODIFICATION	SM-2	2023-10-18	Germany	Acceptable with conditions 2024-02-02	2024-02-05
6	SUBSTANTIAL MODIFICATION	SM-4	2024-03-01	Germany	Acceptable 2024-05-02	2024-05-02
7	NON SUBSTANTIAL MODIFICATION	NSM-3	2024-06-10	Germany		2024-06-10
8	NON SUBSTANTIAL MODIFICATION	NSM-5	2024-06-12			2024-06-12
9	NON SUBSTANTIAL MODIFICATION	NSM-6	2024-06-13	Germany		2024-06-13
10	SUBSEQUENT ADDITION OF MSC	APP-10	2024-06-14		Acceptable 2024-05-02	2024-09-09
11	SUBSEQUENT ADDITION OF MSC	APP-11	2024-06-14		Acceptable 2024-05-02	2024-09-09
12	NON SUBSTANTIAL MODIFICATION	NSM-7	2024-09-09		Acceptable 2024-05-02	2024-09-09
13	NON SUBSTANTIAL MODIFICATION	NSM-8	2024-09-09		Acceptable 2024-05-02	2024-09-09
14	NON SUBSTANTIAL MODIFICATION	NSM-9	2024-09-09	Germany	Acceptable 2024-05-02	2024-09-09
15	NON SUBSTANTIAL MODIFICATION	NSM-10	2024-09-09		Acceptable 2024-05-02	2024-09-09
16	SUBSTANTIAL MODIFICATION	SM-7	2024-09-18	Germany	Acceptable 2024-11-18	2024-11-18
17	NON SUBSTANTIAL MODIFICATION	NSM-11	2025-01-13		Acceptable 2024-11-18	2025-01-13
18	NON SUBSTANTIAL MODIFICATION	NSM-12	2025-01-16		Acceptable 2024-11-18	2025-01-16
19	NON SUBSTANTIAL MODIFICATION	NSM-13	2025-01-16		Acceptable 2024-11-18	2025-01-16
20	NON SUBSTANTIAL MODIFICATION	NSM-14	2025-01-21		Acceptable 2024-11-18	2025-01-21
21	NON SUBSTANTIAL MODIFICATION	NSM-15	2025-01-21		Acceptable 2024-11-18	2025-01-21
22	NON SUBSTANTIAL MODIFICATION	NSM-16	2025-01-24		Acceptable 2024-11-18	2025-01-24
23	NON SUBSTANTIAL MODIFICATION	NSM-17	2025-01-30		Acceptable 2024-11-18	2025-01-30
24	SUBSTANTIAL MODIFICATION	SM-8	2025-03-20	Germany	Acceptable 2025-05-19	2025-05-20
25	NON SUBSTANTIAL MODIFICATION	NSM-18	2025-08-21		Acceptable 2025-05-19	2025-08-21
26	SUBSTANTIAL MODIFICATION	SM-9	2025-09-23		Acceptable	2025-10-29
27	SUBSTANTIAL MODIFICATION	SM-10	2025-10-24		Acceptable	2025-11-17
28	SUBSTANTIAL MODIFICATION	SM-11	2025-12-16	Germany	Acceptable 2026-02-27	2026-02-27

Phase 3 Study to Evaluate Mezigdomide (CC-92480/BMS-986348) in Combination with Carfilzomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma: SUCCESSOR-2

Overview

Key facts

External identifiers

Trial design

Main objective

Conditions and MedDRA coding

Regulatory references

Eligibility criteria

Inclusion criteria 6

Exclusion criteria 4

Endpoints

Primary endpoints 1

Investigational products

Test 10

Sponsors and contacts

Celgene Corp.

Scientific contact point

Public contact point

Third parties 21

Locations

By country

Investigational sites

Country notifications

Oversight and notifications

Unexpected events 1 · Art. 53 CTR

Corrective measures 1 · Art. 77 CTR

Results and documents

Documents 119 files

Application history

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