Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05552976




Registration number
NCT05552976
Ethics application status
Date submitted
21/09/2022
Date registered
23/09/2022

Titles & IDs
Public title
A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2)
Scientific title
A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2
Secondary ID [1] 0 0
CA057-008
Universal Trial Number (UTN)
Trial acronym
SUCCESSOR-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mezigdomide
Treatment: Drugs - Carfilzomib
Treatment: Drugs - Dexamethasone

Experimental: MeziKd (Mezigdomide + Carfilzomib + Dexamethasone) -

Active comparator: Kd (Carfilzomib + Dexamethasone) -


Treatment: Drugs: Mezigdomide
Specified dose on specified days

Treatment: Drugs: Carfilzomib
Specified dose on specified days

Treatment: Drugs: Dexamethasone
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Recommended Mezigdomide Dose
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone
Timepoint [2] 0 0
Up to 176 days
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Overall Response (OR)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Complete Response (CR) Or Better (CRR)
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
Time To Response (TTR)
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Duration Of Response (DOR)
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Time To Progression (TTP)
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Time To Next Treatment (TTNT)
Timepoint [10] 0 0
Up to approximately 5 years
Secondary outcome [11] 0 0
Progression-free Survival 2 (PFS-2)
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
Minimal Residual Disease (MRD) Negativity Rate
Timepoint [12] 0 0
Up to approximately 5 years
Secondary outcome [13] 0 0
Number Of Participants With Adverse Events (AEs)
Timepoint [13] 0 0
Up to approximately 5 years
Secondary outcome [14] 0 0
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
Timepoint [14] 0 0
Up to approximately 5 years
Secondary outcome [15] 0 0
Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
Timepoint [15] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
Inclusion Criteria

- Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:.

i) Myeloma-protein (M-protein) = 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or.

ii) M-protein = 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,.

iii) For participants without measurable disease in sPEP or uPEP: serum free light chain levels > 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal ?/? free light chain ratio.

* Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, [with or without] hematopoietic stem cell transplant, (with or without) consolidation, and/or [with or without] maintenance therapy).
* Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received < 2 cycles are still eligible).
* Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy.
* Participant must have documented disease progression during or after their last antimyeloma regimen.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Participant who has had prior treatment with mezigdomide or carfilzomib.
* Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/07/2029
Actual
Sample size
Target
525
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
Port Macquarie - Mid North Coast Cancer Institute - Port Macquarie
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Local Institution - 0229 - Hobart
Recruitment hospital [8] 0 0
Bendigo Health Care Group - Bendigo
Recruitment hospital [9] 0 0
Epworth Freemasons - East Melbourne
Recruitment hospital [10] 0 0
Austin Health - Heidelberg
Recruitment hospital [11] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2010 - Sydney
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3550 - Bendigo
Recruitment postcode(s) [9] 0 0
3002 - East Melbourne
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
West Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad Autónoma De Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Santa Fe
Country [25] 0 0
Argentina
State/province [25] 0 0
Tucumán
Country [26] 0 0
Argentina
State/province [26] 0 0
Córdoba
Country [27] 0 0
Austria
State/province [27] 0 0
Wien
Country [28] 0 0
Austria
State/province [28] 0 0
Linz
Country [29] 0 0
Brazil
State/province [29] 0 0
Bahia
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio Grande Do Sul
Country [31] 0 0
Brazil
State/province [31] 0 0
São Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio de Janeiro
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Plovdiv
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Sofia
Country [35] 0 0
Canada
State/province [35] 0 0
Nova Scotia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
China
State/province [38] 0 0
Anhui
Country [39] 0 0
China
State/province [39] 0 0
Beijing
Country [40] 0 0
China
State/province [40] 0 0
Fujian
Country [41] 0 0
China
State/province [41] 0 0
Guangdong
Country [42] 0 0
China
State/province [42] 0 0
Henan
Country [43] 0 0
China
State/province [43] 0 0
Hubei
Country [44] 0 0
China
State/province [44] 0 0
Hunan
Country [45] 0 0
China
State/province [45] 0 0
Jiangsu
Country [46] 0 0
China
State/province [46] 0 0
Jiangxi
Country [47] 0 0
China
State/province [47] 0 0
Jilin
Country [48] 0 0
China
State/province [48] 0 0
Liaoning
Country [49] 0 0
China
State/province [49] 0 0
Shaanxi
Country [50] 0 0
China
State/province [50] 0 0
Shandong
Country [51] 0 0
China
State/province [51] 0 0
Shanghai
Country [52] 0 0
China
State/province [52] 0 0
Tianjin
Country [53] 0 0
China
State/province [53] 0 0
Yunnan
Country [54] 0 0
China
State/province [54] 0 0
Zhejiang
Country [55] 0 0
China
State/province [55] 0 0
Taiyuan
Country [56] 0 0
Colombia
State/province [56] 0 0
Antioquia
Country [57] 0 0
Colombia
State/province [57] 0 0
Cesar
Country [58] 0 0
Colombia
State/province [58] 0 0
Cundinamarca
Country [59] 0 0
Colombia
State/province [59] 0 0
Santander
Country [60] 0 0
Colombia
State/province [60] 0 0
Cali
Country [61] 0 0
Denmark
State/province [61] 0 0
Midtjylland
Country [62] 0 0
Denmark
State/province [62] 0 0
Sjælland
Country [63] 0 0
Denmark
State/province [63] 0 0
Syddanmark
Country [64] 0 0
Germany
State/province [64] 0 0
Baden-Wurttemberg
Country [65] 0 0
Germany
State/province [65] 0 0
Bayern
Country [66] 0 0
Germany
State/province [66] 0 0
Niedersachsen
Country [67] 0 0
Germany
State/province [67] 0 0
Nordrhein-Westfalen
Country [68] 0 0
Germany
State/province [68] 0 0
Schleswig-Holstein
Country [69] 0 0
Germany
State/province [69] 0 0
Thüringen
Country [70] 0 0
Germany
State/province [70] 0 0
Berlin
Country [71] 0 0
Germany
State/province [71] 0 0
Dresden
Country [72] 0 0
Germany
State/province [72] 0 0
Düsseldorf
Country [73] 0 0
Germany
State/province [73] 0 0
Heidelberg
Country [74] 0 0
Germany
State/province [74] 0 0
Köln
Country [75] 0 0
Germany
State/province [75] 0 0
Leipzig
Country [76] 0 0
Germany
State/province [76] 0 0
Wuerzburg
Country [77] 0 0
Greece
State/province [77] 0 0
Acha?a
Country [78] 0 0
Greece
State/province [78] 0 0
Attikí
Country [79] 0 0
Greece
State/province [79] 0 0
Thessaloníki
Country [80] 0 0
Hong Kong
State/province [80] 0 0
Hksar
Country [81] 0 0
Hungary
State/province [81] 0 0
Baranya
Country [82] 0 0
Hungary
State/province [82] 0 0
Hajdú-Bihar
Country [83] 0 0
Hungary
State/province [83] 0 0
Szabolcs-Szatmár-Bereg
Country [84] 0 0
Hungary
State/province [84] 0 0
Budapest
Country [85] 0 0
India
State/province [85] 0 0
Delhi
Country [86] 0 0
India
State/province [86] 0 0
Haryana
Country [87] 0 0
India
State/province [87] 0 0
Karnataka
Country [88] 0 0
India
State/province [88] 0 0
Maharashtra
Country [89] 0 0
India
State/province [89] 0 0
Punjab
Country [90] 0 0
India
State/province [90] 0 0
Tamil Nadu
Country [91] 0 0
India
State/province [91] 0 0
Telangana
Country [92] 0 0
India
State/province [92] 0 0
Chandigarh
Country [93] 0 0
Israel
State/province [93] 0 0
HaMerkaz
Country [94] 0 0
Israel
State/province [94] 0 0
Jerusalem
Country [95] 0 0
Israel
State/province [95] 0 0
Zerifin
Country [96] 0 0
Italy
State/province [96] 0 0
Emilia-Romagna
Country [97] 0 0
Italy
State/province [97] 0 0
Lombardia
Country [98] 0 0
Italy
State/province [98] 0 0
Milano
Country [99] 0 0
Italy
State/province [99] 0 0
Bologna
Country [100] 0 0
Italy
State/province [100] 0 0
Catanzaro
Country [101] 0 0
Italy
State/province [101] 0 0
Lecce
Country [102] 0 0
Italy
State/province [102] 0 0
Pisa
Country [103] 0 0
Italy
State/province [103] 0 0
Udine
Country [104] 0 0
Japan
State/province [104] 0 0
Aichi
Country [105] 0 0
Japan
State/province [105] 0 0
Chiba
Country [106] 0 0
Japan
State/province [106] 0 0
Fukuoka
Country [107] 0 0
Japan
State/province [107] 0 0
Hokkaido
Country [108] 0 0
Japan
State/province [108] 0 0
Ibaraki
Country [109] 0 0
Japan
State/province [109] 0 0
Ishikawa
Country [110] 0 0
Japan
State/province [110] 0 0
Iwate
Country [111] 0 0
Japan
State/province [111] 0 0
Kanagawa
Country [112] 0 0
Japan
State/province [112] 0 0
Saitama
Country [113] 0 0
Japan
State/province [113] 0 0
Tokyo
Country [114] 0 0
Japan
State/province [114] 0 0
Yamanashi
Country [115] 0 0
Japan
State/province [115] 0 0
Kumamoto
Country [116] 0 0
Japan
State/province [116] 0 0
Kyoto
Country [117] 0 0
Japan
State/province [117] 0 0
Nagasaki
Country [118] 0 0
Japan
State/province [118] 0 0
Okayama
Country [119] 0 0
Japan
State/province [119] 0 0
Osaka
Country [120] 0 0
Korea, Republic of
State/province [120] 0 0
Seoul-teukbyeolsi [Seoul]
Country [121] 0 0
Netherlands
State/province [121] 0 0
Noord-Brabant
Country [122] 0 0
Netherlands
State/province [122] 0 0
Enschede
Country [123] 0 0
Norway
State/province [123] 0 0
Hordaland
Country [124] 0 0
Norway
State/province [124] 0 0
Rogaland
Country [125] 0 0
Norway
State/province [125] 0 0
Oslo
Country [126] 0 0
Puerto Rico
State/province [126] 0 0
San Juan
Country [127] 0 0
Romania
State/province [127] 0 0
Bucure?ti
Country [128] 0 0
Romania
State/province [128] 0 0
Timi?
Country [129] 0 0
Romania
State/province [129] 0 0
Brasov
Country [130] 0 0
Romania
State/province [130] 0 0
Sibiu
Country [131] 0 0
Singapore
State/province [131] 0 0
Central Singapore
Country [132] 0 0
Spain
State/province [132] 0 0
Barcelona [Barcelona]
Country [133] 0 0
Spain
State/province [133] 0 0
Madrid, Comunidad De
Country [134] 0 0
Spain
State/province [134] 0 0
Santa Cruz De Tenerife
Country [135] 0 0
Spain
State/province [135] 0 0
Valenciana, Comunitat
Country [136] 0 0
Spain
State/province [136] 0 0
Granada
Country [137] 0 0
Spain
State/province [137] 0 0
Madrid
Country [138] 0 0
Spain
State/province [138] 0 0
Málaga
Country [139] 0 0
Taiwan
State/province [139] 0 0
Chiayi
Country [140] 0 0
Taiwan
State/province [140] 0 0
Kaohsiung
Country [141] 0 0
Taiwan
State/province [141] 0 0
Taichung
Country [142] 0 0
Taiwan
State/province [142] 0 0
Tainan
Country [143] 0 0
Taiwan
State/province [143] 0 0
Taipei
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Devon
Country [145] 0 0
United Kingdom
State/province [145] 0 0
England
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Glasgow City
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Birmingham
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Leeds
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information 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/disclosurecommitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05552976