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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)
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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
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Secondary ID [1]
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2021-001957-30
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Secondary ID [2]
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CA057-001
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Universal Trial Number (UTN)
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Trial acronym
SUCCESSOR-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma
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Condition category
Condition code
Cancer
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0
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Other cancer types
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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Timepoint [1]
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From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years)
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Secondary outcome [1]
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Recommended mezigdomide dose
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Assessment method [1]
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Stage 1 only
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Timepoint [1]
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Up to 12 Months
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Secondary outcome [2]
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Plasma concentrations of mezigdomide
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Assessment method [2]
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Stage 1 only
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Timepoint [2]
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Up to 134 Days
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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Timepoint [3]
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From date of randomization to date of death due to any cause (Up to approximately 5 years)
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Secondary outcome [4]
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Overall Response (OR)
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Assessment method [4]
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OR is defined as the number of participants who achieve best response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma
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Timepoint [4]
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Up to approximately 5 years
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Secondary outcome [5]
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Complete Response (CR) or better
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Assessment method [5]
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Defined as the number of participants who achieve best response of complete response (CR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma
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Timepoint [5]
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Up to approximately 5 Years
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Secondary outcome [6]
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Very Good Partial Response (VGPR) or better
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Assessment method [6]
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Defined as the number of participants who achieve best response of very good partial response (VGPR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma
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Timepoint [6]
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Up to approximately 5 years
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Secondary outcome [7]
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Time to Response (TTR)
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Assessment method [7]
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Timepoint [7]
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Up to approximately 5 years
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Secondary outcome [8]
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Duration of Response (DOR)
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Assessment method [8]
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Timepoint [8]
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Up to approximately 5 years
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Secondary outcome [9]
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Time to Progression (TTP)
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Assessment method [9]
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Timepoint [9]
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Up to approximately 5 years
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Secondary outcome [10]
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Time to Next Treatment (TTNT)
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Assessment method [10]
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0
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Timepoint [10]
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Up to approximately 5 years
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Secondary outcome [11]
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Progression-free Survival 2 (PFS-2)
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Assessment method [11]
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Timepoint [11]
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Up to approximately 5 years
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Secondary outcome [12]
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Minimal Residual Disease (MRD) negativity
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Assessment method [12]
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Defined as the number of participants who achieve complete response (CR) or better and MRD negative (defined at a sensitivity of a minimum of 1 in 105 nucleated cells)
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Timepoint [12]
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Up to approximately 5 years
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Secondary outcome [13]
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Number of participants with Adverse Events (AEs)
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Assessment method [13]
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Timepoint [13]
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Up to approximately 5 years
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Secondary outcome [14]
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Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) scores
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Assessment method [14]
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The EORTC QLQ-C30 is the most commonly used quality of life instrument in oncology trials. The QLQ-C30 consists of 30 questions incorporated into 5 functional domains physical, role, cognitive, emotional, and social), 9 symptom/other scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a single global Quality of Life (QoL)/global health status score. Items in the functional and symptom scale use raw participant response of 1 to 4, where 1 = "not at all" and 4 = "very much." The 2 global items contain responses ranging from 1 "very poor" to 7 "excellent." The recall period is 1 week. All domain scores are transformed in a range from 0 to 100, where a higher functional score indicates more favorable outcomes and a higher score on the symptom domains indicates a less favorable participant outcome. Stage 2 only.
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Timepoint [14]
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Up to approximately 5 years
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Secondary outcome [15]
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Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) score
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Assessment method [15]
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The EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Participants rate symptoms or problems on a scale from 1 to 4 where 1 = "not at all" and 4 = "very much." Stage 2 only.
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Timepoint [15]
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Up to approximately 5 years
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/11/2033
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Actual
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Sample size
Target
810
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Calvary Mater Newcastle - Waratah
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Wollongong Hospital-Illawarra Cancer Care Centre - Wollongong
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Sunshine Coast University Hospital - Birtinya
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Box Hill Hospital - Box Hill
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The Alfred Hospital - Melbourne
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St Vincent's Hospital - Melbourne
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Recruitment hospital [8]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2298 - Waratah
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2500 - Wollongong
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4575 - Birtinya
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3004 - Melbourne
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Recruitment postcode(s) [7]
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3065 - Melbourne
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
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Sicilia
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Italy
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Bologna
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Italy
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Pavia
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Italy
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Roma
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Chiba
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Iwate
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Japan
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Kanagawa
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Japan
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Saitama
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Shizuoka
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Japan
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Tokyo
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Hiroshima
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Japan
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Kumamoto
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Japan
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Nagasaki
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Korea, Republic of
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Seoul
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New Zealand
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Bay Of Plenty
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Otago
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Auckland
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Poland
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Pomorskie
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Poland
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Wielkopolskie
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Poland
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Katowice
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Portugal
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Braga
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Portugal
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Lisbon
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Portugal
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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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Romania
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Cluj Napoca
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Romania
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Iasi
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Spain
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Balears [Baleares]
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Catalunya [Cataluña]
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Illes Balears
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Spain
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Murcia, Región De
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Spain
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Málaga
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Spain
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Cáceres
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Spain
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León
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Spain
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Madrid
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Turkey
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Ankara
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Istanbul
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Izmir
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Kayseri
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Turkey
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Samsun
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United Kingdom
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Cambridgeshire
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United Kingdom
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England
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United Kingdom
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Great Britain
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United Kingdom
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Greater London
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United Kingdom
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Leicestershire
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United Kingdom
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London, City Of
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United Kingdom
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Barnet
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Stoke-on-Trent
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Celgene
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.
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Trial website
https://clinicaltrials.gov/study/NCT05519085
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for public queries
Name
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Phone
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855-907-3286
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
See Plan Description
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Available to whom?
See Plan Description
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Available for what types of analyses?
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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
Query!
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