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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
7/11/2024

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)
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)
Secondary ID [1] 0 0
U1111-1260-2872
Secondary ID [2] 0 0
CC-220-MM-002
Universal Trial Number (UTN)
Trial acronym
EXCALIBER-RRMM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Minimal Residual Disease (MRD) negativity rate
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Overall Response Rate (ORR)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Time to response (TTR)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Duration of Response (DoR)
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Time to Progression (TTP)
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
Time to Next Treatment (TTNT)
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Progression-free Survival 2 (PFS2)
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Safety
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
Timepoint [10] 0 0
Up to approximately 5 years
Secondary outcome [11] 0 0
European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
Recommended iberdomide dose for Stage 2
Timepoint [12] 0 0
Up to approximately 1 year
Secondary outcome [13] 0 0
Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))
Timepoint [13] 0 0
Up to approximately 1 year
Secondary outcome [14] 0 0
Maximum plasma concentration (Cmax)
Timepoint [14] 0 0
Up to approximately 1 year
Secondary outcome [15] 0 0
Time to maximum plasma concentration (Tmax)
Timepoint [15] 0 0
Up to approximately 1 year

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
23/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/06/2032
Actual
Sample size
Target
864
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Flinders Medical Centre, Dept Of Oncology - Bedford Park
Recruitment hospital [5] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [6] 0 0
Epworth Hospital - East Melbourne
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [9] 0 0
Perth Blood Institute - West Perth
Recruitment hospital [10] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [11] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [12] 0 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3001 - East Melbourne
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment postcode(s) [9] 0 0
6005 - West Perth
Recruitment postcode(s) [10] 0 0
2050 - Camperdown
Recruitment postcode(s) [11] 0 0
3065 - Fitzroy
Recruitment postcode(s) [12] 0 0
ACT 2605 - Garran
Recruitment outside Australia
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London
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Oxford
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Portsmouth
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Sutton
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT04975997
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04975997