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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05827016
Collaborator
(none)
1,216
274
4
150.6
4.4
0

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
Mar 15, 2029
Anticipated Study Completion Date :
Jan 1, 2036

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A1: Iberdomide Dose 1

Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
  • Experimental: Arm A2: Iberdomide Dose 2

    Drug: Iberdomide
    Specified dose on specified days
    Other Names:
  • CC-220
  • BMS-986382
  • Experimental: Arm A3: Iberdomide Dose 3

    Drug: Iberdomide
    Specified dose on specified days
    Other Names:
  • CC-220
  • BMS-986382
  • Active Comparator: Arm B: Lenalidomide

    Drug: Lenalidomide
    Specified dose on specified days
    Other Names:
  • Revlimid®
  • Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (PFS) [Up to 6 years]

    Secondary Outcome Measures

    1. Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment [Up to 6 years]

    2. Overall Survival [Up to 12 years]

    3. Recommended iberdomide dose for Stage 2 [Up to 1 year]

    4. Area under the iberdomide plasma concentration-time curve from time zero to tau [Up to 1 year]

    5. Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU) [Up to 1 year]

    6. Maximum iberdomide concentration (Cmax) [Up to 1 year]

    7. Time to maximum iberdomide plasma concentration (Tmax) [Up to 1 year]

    8. Number of participants with adverse events (AEs) [Up to 6 years]

    9. Progression-free survival on next line of treatment (PFS2) [Up to 6 years]

    10. Achieving MRD negativity in participants with CR or better at any time after the date of randomization [Up to 6 years]

    11. Conversion from MRD positive to MRD negative in participants with CR or better [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 6 months or 1 year apart, without any examination showing MRD positive status in between assessments [Up to 6 years]

    13. Time to progression (TTP) [Up to 6 years]

    14. Time to next treatment (TTNT) [Up to 6 years]

    15. Best response achieved prior to progressive disease (PD) [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) [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) [Up to 6 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center Orange California United States 92868
    2 Rocky Mountain Cancer Centers Aurora Colorado United States 80012-5405
    3 Poudre Valley Health Care Fort Collins Colorado United States 80528-3413
    4 Mayo Clinic Florida Jacksonville Florida United States 32224-1865
    5 Woodlands Medical Specialists - Pensacola Pensacola Florida United States 32503-2339
    6 H. Lee Moffitt Cancer Center & Research Institute Tampa Florida United States 33612-9416
    7 Cleveland Clinic Florida Weston Florida United States 33331-3609
    8 University Cancer & Blood Center, LLC Athens Georgia United States 30607-1465
    9 The Winship Cancer Institute of Emory University Atlanta Georgia United States 30322-1013
    10 Augusta University - Georgia Cancer Center Augusta Georgia United States 30912
    11 The University of Chicago Medical Center - Duchossois Center for Advanced Medicine Chicago Illinois United States 60637-1426
    12 University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion Westwood Kansas United States 66205-2003
    13 Maryland Oncology Hematology, PA- Clinton Clinton Maryland United States 20735-4230
    14 University of Michigan Rogel Comprehensive Cancer Center UMCCC Ann Arbor Michigan United States 48109-5000
    15 Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - Detroit Detroit Michigan United States 48202-2610
    16 St. John Hospital and Medical Center - Van Elslander Cancer Center Grosse Pointe Woods Michigan United States 48236-2858
    17 Mayo Clinic - Transplant Center - Rochester Rochester Minnesota United States 55905-0001
    18 Hattiesburg Clinic - Hematology & Oncology Hattiesburg Mississippi United States 39401
    19 Midwest Oncology Associates - Kansas City Kansas City Missouri United States 64132
    20 Dartmouth-Hitchcock Medical Center (DHMC) Lebanon New Hampshire United States 03756-1000
    21 Morristown Medical Center Morristown New Jersey United States 07960
    22 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08901-1914
    23 NYU Langone Health New York New York United States 10016-6402
    24 Memorial Sloan-Kettering Cancer Center New York New York United States 10021-0005
    25 Columbia University Medical Center - Herbert Irving Pavilion Location New York New York United States 10032-3729
    26 Novant Health Cancer Institute - Elizabeth Charlotte North Carolina United States 28803-2493
    27 Oncology Hematology Care, Inc. - Cincinnati - Galbraith Rd Cincinnati Ohio United States 45236-2725
    28 Cleveland Clinic Cleveland Ohio United States 44195
    29 Toledo Clinic Cancer Centers Toledo Ohio United States 43623
    30 Willamette Valley Cancer Institute Eugene Oregon United States 97401
    31 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    32 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111-2497
    33 University of Pittsburgh - Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
    34 Cancer Care Associates of York York Pennsylvania United States 17403-5049
    35 Tennessee Oncology - Chattanooga Oncology & Hematology Associates Chattanooga Tennessee United States 37404-1130
    36 Tennessee Oncology Nashville Tennessee United States 37203-1625
    37 Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    38 UT Southwestern-Harold C. Simmons Cancer Center Dallas Texas United States 75390-0001
    39 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    40 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792-0001
    41 Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer Center Milwaukee Wisconsin United States 53226-1222
    42 Local Institution - 0184 Buenos Aires B Argentina C1114AAN
    43 Local Institution - 0259 Mar del Plata B Argentina 7600
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    231 Local Institution - 0023 Braga Portugal 4710-243
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    247 Local Institution - 0232 Badalona Spain 08916
    248 Local Institution - 0164 Palma de Mallorca Spain 07120
    249 Local Institution - 0163 Pamplona Spain 31008
    250 Local Institution - 0157 Stockholm AB Sweden 141 86
    251 Local Institution - 0171 Luleå BD Sweden 971 80
    252 Local Institution - 0230 Goeteborg Sweden 413 46
    253 Local Institution - 0170 Helsingborg Sweden 254 37
    254 Local Institution - 0218 Linkoping Sweden 581 85
    255 Local Institution - 0168 Aarau Switzerland 5001
    256 Local Institution - 0153 Kao-Hsiung Taiwan 83301
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    267 Local Institution - 0173 Aberdeen ABD United Kingdom AB25 2ZN
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    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05827016
    Other Study ID Numbers:
    • IM048-022
    • 2022-501515-14
    • U1111-1280-9492
    First Posted:
    Apr 24, 2023
    Last Update Posted:
    May 1, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 1, 2023