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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05519085




Registration number
NCT05519085
Ethics application status
Date submitted
25/08/2022
Date registered
29/08/2022

Titles & IDs
Public title
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Scientific title
A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1
Secondary ID [1] 0 0
2023-509859-13
Secondary ID [2] 0 0
CA057-001
Universal Trial Number (UTN)
Trial acronym
SUCCESSOR-1
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 - Pomalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone

Experimental: MeziVd (mezigdomide, bortezomib and dexamethasone) -

Experimental: PVd (pomalidomide, bortezomib and dexamethasone) -


Treatment: Drugs: mezigdomide
Specified dose on specified days

Treatment: Drugs: Pomalidomide
Specified dose on specified days

Treatment: Drugs: Bortezomib
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
From date of randomization to date of disease progression or death due to any cause (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
Timepoint [2] 0 0
Up to 134 Days
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
From date of randomization to date of death due to any cause (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
Complete Response (CR) or better
Timepoint [5] 0 0
Up to approximately 5 Years
Secondary outcome [6] 0 0
Very Good Partial Response (VGPR) or better
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
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 European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) scores
Timepoint [14] 0 0
Up to approximately 5 years
Secondary outcome [15] 0 0
Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) score
Timepoint [15] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
Inclusion Criteria

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

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

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

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

* Participants received 1 to 3 prior lines of antimyeloma therapy.
* Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.

i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.

ii) Participants who progressed while being treated with ixazomib monotherapy maintenance = 6 months prior to the time of starting study treatment are not excluded.

* For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
* Participant has had prior treatment with mezigdomide or pomalidomide.
* 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
20/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2033
Actual
Sample size
Target
810
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
Wollongong Hospital-Illawarra Cancer Care Centre - Wollongong
Recruitment hospital [4] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [8] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4575 - Birtinya
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3065 - Melbourne
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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Colorado
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Connecticut
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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New York
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Tennessee
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Utah
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Zhejiang
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Taiyuan
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Brno-mesto
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Praha
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Gard
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Limoges
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Nantes
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Tours
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Île-de-France
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Bayern
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Hessen
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Bamberg
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Hamburg
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Tuebingen
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Attikí
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Gujarat
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Haryana
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Tamil Nadu
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Uttar Pradesh
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Ludhiana
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Puducherry
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Connaught
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Ireland
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Cork
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Dublin
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HaMerkaz
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Israel
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HaTsafon
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Tall Abib
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Israel
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Yerushalayim
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Israel
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Peatch Tikva
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Italy
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Emilia-Romagna
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Italy
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Sicilia
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Bologna
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Chiba
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Hokkaido
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Iwate
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Kanagawa
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Saitama
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Tokyo
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Hiroshima
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Kumamoto
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Nagasaki
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Seoul Teugbyeolsi
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Seoul
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Bay Of Plenty
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Otago
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New Zealand
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Auckland
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Kujawsko-pomorskie
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Katowice
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Portugal
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Braga
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Lisbon
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Porto
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Puerto Rico
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San Juan
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Romania
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Bucharest
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Cluj Napoca
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Romania
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Iasi
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Gauteng
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Western Cape
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Catalunya [Cataluña]
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Illes Balears
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Murcia, Región De
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Málaga
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Cáceres
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León
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Madrid
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Turkey
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Ankara
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Istanbul
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Samsun
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Cambridgeshire
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England
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Great Britain
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Greater London
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Leicestershire
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Barnet
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Newcastle upon Tyne
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Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
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/NCT05519085