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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04975997
Registration number
NCT04975997
Ethics application status
Date submitted
2/07/2021
Date registered
26/07/2021
Date last updated
26/06/2024
Titles & IDs
Public title
Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) 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 Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
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Secondary ID [1]
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U1111-1260-2872
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Secondary ID [2]
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CC-220-MM-002
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Universal Trial Number (UTN)
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Trial acronym
EXCALIBER-RRMM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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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 - Dexamethasone
Treatment: Drugs - Daratumumab
Treatment: Drugs - Bortezomib
Treatment: Drugs - Iberdomide
Treatment: Drugs - Iberdomide
Treatment: Drugs - Iberdomide
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1 - Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2 -
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3 -
Active comparator: Daratumumab in combination with dexamethasone and bortezomib - Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
Treatment: Drugs: Dexamethasone
Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
Treatment: Drugs: Daratumumab
Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7 of a 28-day cycle
Treatment: Drugs: Bortezomib
Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.
Treatment: Drugs: Iberdomide
Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle
Treatment: Drugs: Iberdomide
Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle
Treatment: Drugs: Iberdomide
Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle
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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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To compare the efficacy of iberdomide, daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in terms of progression-free survival (PFS) in participants with relapsed or refractory multiple myeloma (RRMM).
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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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Overall Survival (OS)
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Assessment method [1]
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To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, daratumumab, and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd).
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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Minimal Residual Disease (MRD) negativity rate
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Assessment method [2]
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Proportion of participants who achieve complete response (CR) or better and are MRD negative (defined at a sensitivity of a minimum of 1 in 105 nucleated cells by next generation flow cytometry).
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [3]
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Overall Response Rate (ORR)
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Assessment method [3]
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Calculated as percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for multiple myeloma.
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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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Time to response (TTR)
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Assessment method [4]
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Time from randomization to the first documentation of response (PR or better).
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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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Duration of Response (DoR)
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Assessment method [5]
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Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.
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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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Time to Progression (TTP)
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Assessment method [6]
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The time from randomization to the first documented disease progression.
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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 Next Treatment (TTNT)
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Assessment method [7]
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Time from randomization to the start of the next antimyeloma treatment.
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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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Progression-free Survival 2 (PFS2)
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Assessment method [8]
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Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.
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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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Safety
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Assessment method [9]
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Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.
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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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European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
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Assessment method [10]
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Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30.
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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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European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
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Assessment method [11]
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EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ- MY20.
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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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Recommended iberdomide dose for Stage 2
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Assessment method [12]
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Timepoint [12]
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Up to approximately 1 year
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Secondary outcome [13]
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Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))
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Assessment method [13]
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Timepoint [13]
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Up to approximately 1 year
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Secondary outcome [14]
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Maximum plasma concentration (Cmax)
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Assessment method [14]
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0
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Timepoint [14]
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Up to approximately 1 year
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Secondary outcome [15]
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Time to maximum plasma concentration (Tmax)
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Assessment method [15]
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Timepoint [15]
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Up to approximately 1 year
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Eligibility
Key inclusion criteria
Inclusion Criteria
* Documented diagnosis of multiple myeloma (MM) and measurable disease.
* Received 1 to 2 prior lines of anti-myeloma therapy.
* Must have documented disease progression during or after their last anti-myeloma regimen.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
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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
* Any condition that confounds the ability to interpret data from the study.
* Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
* Known central nervous system involvement with MM.
* Prior therapy with iberdomide.
* 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
23/06/2022
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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
25/06/2032
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Actual
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Sample size
Target
864
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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Sunshine Coast University Hospital - Birtinya
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The Townsville Hospital - Douglas
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Royal Adelaide Hospital - Adelaide
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Flinders Medical Centre, Dept Of Oncology - Bedford Park
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Monash Medical Centre - Clayton
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Epworth Hospital - East Melbourne
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The Alfred Hospital - Melbourne
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Fiona Stanley Hospital - Murdoch
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Perth Blood Institute - West Perth
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [11]
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St Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [12]
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The Canberra Hospital - Garran
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Recruitment postcode(s) [1]
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4575 - Birtinya
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Recruitment postcode(s) [2]
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4814 - Douglas
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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5042 - Bedford Park
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3001 - East Melbourne
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Recruitment postcode(s) [7]
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3004 - Melbourne
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Recruitment postcode(s) [8]
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6150 - Murdoch
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Recruitment postcode(s) [9]
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6005 - West Perth
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Recruitment postcode(s) [10]
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2050 - Camperdown
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Recruitment postcode(s) [11]
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3065 - Fitzroy
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Recruitment postcode(s) [12]
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ACT 2605 - Garran
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Recruitment outside Australia
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West Bengal
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India
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Cork
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Ireland
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HaZafon
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Haifa
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Israel
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
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Lazio
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Italy
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Italy
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Catania
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Italy
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Genova
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Italy
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Milano
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Italy
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Novara
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Italy
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Pavia
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Italy
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Pisa
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Italy
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Reggio Calabria
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Italy
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Italy
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Roma
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Italy
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San Giovanni Rotondo FG
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Italy
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Terni
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Italy
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Japan
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Japan
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Yamanashi
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Japan
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Kamogawa
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Japan
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Japan
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Nagoya
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Japan
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Okayama
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Japan
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Japan
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Osaka
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Japan
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Sapporo
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Japan
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Sendai
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Japan
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Shibuya-ku
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Japan
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Shinagawa-ku, Tokyo
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Japan
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Toyohashi
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Korea, Republic of
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Daegu
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Gyeonggi-do
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Korea, Republic of
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Hwasun-gun
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Den Haag
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Bergen
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Oslo
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Trondheim
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Podlaskie
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Portugal
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Coimbra
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Porto
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Boras
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Taipei
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Kayseri
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United Kingdom
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Nottinghamshire
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Birmingham
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Oxford
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Portsmouth
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United Kingdom
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Sutton
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United Kingdom
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Wolverhampton
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Funding & Sponsors
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Commercial sector/industry
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Name
Celgene
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Ethics approval
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Summary
Brief summary
This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).
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Trial website
https://clinicaltrials.gov/study/NCT04975997
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Public notes
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Contacts
Principal investigator
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0
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
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT04975997
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