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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)
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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
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Secondary ID [1]
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0
CA057-008
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Universal Trial Number (UTN)
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Trial acronym
SUCCESSOR-2
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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 - 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
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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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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 in Combination with Carfilzomib and Dexamethasone
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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 176 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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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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0
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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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Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)
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Assessment method [5]
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VGPRR will be calculated as the percentage of participants who achieve best response of VGPR or better according to the International Myeloma Working Group (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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Complete Response (CR) Or Better (CRR)
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Assessment method [6]
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CRR will be calculated as the percentage of participants who achieve best response of CR 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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0
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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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0
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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 Rate
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Assessment method [12]
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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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0
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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 the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
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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 the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
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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 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.
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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 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.
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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
10/01/2023
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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
25/07/2029
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Actual
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Sample size
Target
525
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Gosford Hospital - Gosford
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Port Macquarie - Mid North Coast Cancer Institute - Port Macquarie
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Royal North Shore Hospital - St Leonards
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St Vincent's Hospital - Sydney
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]
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Local Institution - 0229 - Hobart
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Bendigo Health Care Group - Bendigo
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Epworth Freemasons - East Melbourne
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Recruitment hospital [10]
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Austin Health - Heidelberg
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Recruitment hospital [11]
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St Vincent's Hospital - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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2250 - Gosford
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2444 - Port Macquarie
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Recruitment postcode(s) [4]
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2065 - St Leonards
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Recruitment postcode(s) [5]
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2010 - Sydney
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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7000 - Hobart
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Recruitment postcode(s) [8]
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3550 - Bendigo
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Recruitment postcode(s) [9]
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3002 - East Melbourne
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Recruitment postcode(s) [10]
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3084 - Heidelberg
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Recruitment postcode(s) [11]
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3065 - Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Delaware
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Georgia
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Idaho
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Maryland
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Massachusetts
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New Jersey
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New York
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North Carolina
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Ohio
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Rhode Island
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South Carolina
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Washington
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Ciudad Autónoma De Buenos Aires
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Italy
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Chiba
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Fukuoka
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Tokyo
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Yamanashi
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Okayama
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Japan
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Osaka
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Korea, Republic of
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Netherlands
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Noord-Brabant
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Netherlands
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Enschede
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Oslo
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Puerto Rico
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San Juan
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Romania
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Bucure?ti
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Romania
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Timi?
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Romania
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Brasov
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Romania
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Sibiu
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Central Singapore
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Spain
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Madrid, Comunidad De
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Santa Cruz De Tenerife
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Granada
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Madrid
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Kaohsiung
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Taichung
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Tainan
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Taipei
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United Kingdom
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Devon
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United Kingdom
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England
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United Kingdom
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Birmingham
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United Kingdom
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Glasgow
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United Kingdom
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Leeds
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United Kingdom
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Taunton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.
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Trial website
https://clinicaltrials.gov/study/NCT05552976
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for public queries
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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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
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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