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Active, not recruiting

NCT Number: NCT05827016

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

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).

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Austral, Pilar, B, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, 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.

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.

Treatment and study plan

Iberdomide

Drug

Specified dose on specified days

Other names: CC-220, BMS-986382

Lenalidomide

Drug

Specified dose on specified days

Other names: Revlimid®

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: Up to 6 years

Secondary outcomes

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

    Time frame: Up to 6 years

  2. Overall Survival

    Time frame: Up to 12 years

  3. Recommended iberdomide dose for Stage 2

    Time frame: Up to 1 year

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

    Time frame: Up to 1 year

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

    Time frame: Up to 1 year

  6. Maximum iberdomide concentration (Cmax)

    Time frame: Up to 1 year

  7. Time to maximum iberdomide plasma concentration (Tmax)

    Time frame: Up to 1 year

  8. Number of participants with adverse events (AEs)

    Time frame: Up to 6 years

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

    Time frame: Up to 6 years

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

    Time frame: Up to 6 years

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

    Time frame: 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

    Time frame: Up to 6 years

  13. Time to progression (TTP)

    Time frame: Up to 6 years

  14. Time to next treatment (TTNT)

    Time frame: Up to 6 years

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

    Time frame: 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)

    Time frame: 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)

    Time frame: Up to 6 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2029
Study completion
2036
First posted
Apr 24, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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