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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05827016




Registration number
NCT05827016
Ethics application status
Date submitted
11/04/2023
Date registered
24/04/2023

Titles & IDs
Public title
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma
Scientific title
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
Secondary ID [1] 0 0
2022-501515-14
Secondary ID [2] 0 0
IM048-022
Universal Trial Number (UTN)
Trial acronym
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 - Iberdomide
Treatment: Drugs - Lenalidomide

Experimental: Arm A1: Iberdomide Dose 1 -

Experimental: Arm A2: Iberdomide Dose 2 -

Experimental: Arm A3: Iberdomide Dose 3 -

Active comparator: Arm B: Lenalidomide -


Treatment: Drugs: Iberdomide
Specified dose on specified days

Treatment: Drugs: Lenalidomide
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
Up to 6 years
Secondary outcome [1] 0 0
Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment
Timepoint [1] 0 0
Up to 6 years
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
Up to 12 years
Secondary outcome [3] 0 0
Recommended iberdomide dose for Stage 2
Timepoint [3] 0 0
Up to 1 year
Secondary outcome [4] 0 0
Area under the iberdomide plasma concentration-time curve from time zero to tau
Timepoint [4] 0 0
Up to 1 year
Secondary outcome [5] 0 0
Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)
Timepoint [5] 0 0
Up to 1 year
Secondary outcome [6] 0 0
Maximum iberdomide concentration (Cmax)
Timepoint [6] 0 0
Up to 1 year
Secondary outcome [7] 0 0
Time to maximum iberdomide plasma concentration (Tmax)
Timepoint [7] 0 0
Up to 1 year
Secondary outcome [8] 0 0
Number of participants with adverse events (AEs)
Timepoint [8] 0 0
Up to 6 years
Secondary outcome [9] 0 0
Progression-free survival on next line of treatment (PFS2)
Timepoint [9] 0 0
Up to 6 years
Secondary outcome [10] 0 0
Achieving MRD negativity in participants with CR or better at any time after the date of randomization
Timepoint [10] 0 0
Up to 6 years
Secondary outcome [11] 0 0
Conversion from MRD positive to MRD negative in participants with CR or better
Timepoint [11] 0 0
Up to 6 years
Secondary outcome [12] 0 0
Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 6 months or 1 year apart, without any examination showing MRD positive status in between assessments
Timepoint [12] 0 0
Up to 6 years
Secondary outcome [13] 0 0
Time to progression (TTP)
Timepoint [13] 0 0
Up to 6 years
Secondary outcome [14] 0 0
Time to next treatment (TTNT)
Timepoint [14] 0 0
Up to 6 years
Secondary outcome [15] 0 0
Best response achieved prior to progressive disease (PD)
Timepoint [15] 0 0
Up to 6 years
Secondary outcome [16] 0 0
Patient-reported health-related quality of life (HRQoL) outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ-C30)
Timepoint [16] 0 0
Up to 6 years
Secondary outcome [17] 0 0
Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20)
Timepoint [17] 0 0
Up to 6 years

Eligibility
Key inclusion criteria
Inclusion Criteria

* Confirmed diagnosis of symptomatic multiple myeloma (MM).
* Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
* Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or Velcade® (bortezomib), cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
* Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
* Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
* Known central nervous system/meningeal involvement of MM.
* Prior history of malignancies, other than MM, unless the participant has been free of the disease for = 5 years.
* 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
22/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2036
Actual
Sample size
Target
1216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3800 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
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United States of America
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Florida
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United States of America
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Georgia
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Illinois
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Michigan
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Argentina
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B
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Córdoba
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Linz
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St. Pölten
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BY
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Freiburg
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Jena
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Tübingen
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Greece
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G
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I
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Athens
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Ramat Gan
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Israel
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Tel Aviv-Yafo
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Italy
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CT
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Italy
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FI
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Italy
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GE
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Italy
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MI
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Italy
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PI
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Italy
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RM
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Italy
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TO
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Italy
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Naples
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Italy
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Pavia
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Italy
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Rome
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Kanagawa
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Japan
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Kumamoto
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Chiba-shi
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Japan
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Gifu-Shi
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Japan
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Higashiibaraki-Gun
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Japan
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Hiroshima-shi
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Isehara-shi
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Coimbra
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Portugal
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B
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IS
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Taipei
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Taoyuan
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ABD
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Berkshire
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United Kingdom
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United Kingdom
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Staffordshire
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United Kingdom
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Edinburgh
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United Kingdom
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London
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United Kingdom
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
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 Myer 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/NCT05827016