A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

NCT05827016
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,230
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Lead sponsor
Bristol-Myers Squibb
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Start date
2023-06-22
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Number of sites
271
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Summary
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
clinicaltrials.gov
Short title
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma
clinicaltrials.gov
Official 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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2036-01-01
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First posted
2023-04-24
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Registry last updated
2026-07-02
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Primary completion date
2029-03-15
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Start date
2023-06-22
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Actual participants
1,230
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Participants
1,230
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
271
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Bristol-Myers Squibb
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05827016
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ClinicalTrials.gov ID
NCT05827016
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Progression-free survival (PFS)

    Timeframe: Up to 6 years

  1. Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment

    Timeframe: Up to 6 years

  2. Overall Survival

    Timeframe: Up to 12 years

  3. Recommended iberdomide dose for Stage 2

    Timeframe: Up to 1 year

  4. Area under the iberdomide plasma concentration-time curve from time zero to tau

    Timeframe: Up to 1 year

  5. Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)

    Timeframe: Up to 1 year

  6. Maximum iberdomide concentration (Cmax)

    Timeframe: Up to 1 year

  7. Time to maximum iberdomide plasma concentration (Tmax)

    Timeframe: Up to 1 year

  8. Number of participants with adverse events (AEs)

    Timeframe: Up to 6 years

  9. Progression-free survival on next line of treatment (PFS2)

    Timeframe: Up to 6 years

  10. Achieving MRD negativity in participants with CR or better at any time after the date of randomization

    Timeframe: Up to 6 years

  11. Conversion from MRD positive to MRD negative in participants with CR or better

    Timeframe: Up to 6 years

  12. Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 1 year apart, without any examination showing MRD positive status in between assessments

    Timeframe: Up to 6 years

  13. Time to progression (TTP)

    Timeframe: Up to 6 years

  14. Time to next treatment (TTNT)

    Timeframe: Up to 6 years

  15. Best response achieved prior to progressive disease (PD)

    Timeframe: Up to 6 years

  16. 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)

    Timeframe: Up to 6 years

  17. Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20)

    Timeframe: Up to 6 years

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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, daratumumab + bortezomib/thalidomide/dexamethasone [D-VTd] and daratumumab + bortezomib/ lenalidomide/dexamethasone [D-VRd]), or VCd / daratumumab + bortezomib/cyclophosphamide/dexamethasone [D-VCd], and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
  • Participants within 12 months (single transplant) or 15 months (tandem transplant) 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.

  • 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.
Sources for eligibility
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  • Rocky Mountain Cancer CentersAurora, United States
  • Mayo Clinic Hospital - FloridaJacksonville, United States
  • Local Institution - 0308Tampa, United States
  • H. Lee Moffitt Cancer Center & Research InstituteTampa, United States
  • Cleveland ClinicWeston, United States
  • University Cancer & Blood CenterAthens, United States
  • The Winship Cancer Institute of Emory UniversityAtlanta, United States
  • Augusta University - Georgia Cancer CenterAugusta, United States
  • Local Institution - 0237Chicago, United States
  • University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care PavilionWestwood, United States
  • Maryland Oncology Hematology, PA- ClintonClinton, United States
  • UMass Memorial Medical CenterWorcester, United States
  • University of Michigan - Rogel Cancer CenterAnn Arbor, United States
  • Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - DetroitDetroit, United States
  • Cancer & Hematology Centers of Western Michigan (CHCWM)Grand Rapids, United States
  • Mayo Clinic Cancer Center (MCCC) - RochesterRochester, United States
  • Hattiesburg Clinic - Hematology & OncologyHattiesburg, United States
  • Morristown Medical CenterMorristown, United States
  • Perlmutter Cancer Center - Sunset ParkBrooklyn, United States
  • Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates-MineolaMineola, United States
  • NYU Langone HealthNew York, United States
  • Columbia University Medical Center - Herbert Irving Pavilion LocationNew York, United States
  • Optum Medical Care PCWestbury, United States
  • Levine Cancer InstituteCharlotte, United States
  • Novant Health Cancer Institute - ElizabethCharlotte, United States

And 246 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1280-9492
  • 2022-501515-14-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (4)