A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (QUINTESSENTIAL-2)

Last updated: February 26, 2025
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Overall Status: Active - Recruiting

Phase

3

Condition

Leukemia

Platelet Disorders

Bone Diseases

Treatment

Carfilzomib

Dexamethasone

Cyclophosphamide

Clinical Study ID

NCT06615479
CA088-1007
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to compare the efficacy and safety of BMS-986393 versus standard regimens in adult participants with Relapsed or Refractory and Lanalidomide-refractory Multiple Myeloma.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Participants must have relapsed or refractory multiple myeloma (RRMM).

  • Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody, and be refractory to lenalidomide (LEN) (progression on or within 60 days of completing LEN therapy).

  • Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.

  • Participants must have measurable disease during screening.

  • Participants must have adequate organ function.

  • Participants must have an Eastern Cooperative Oncology group performance status 0 or

Exclusion Criteria

  • Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).

  • Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.

  • Participants must not need urgent treatment due to rapidly progressing MM.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 440
Treatment Group(s): 7
Primary Treatment: Carfilzomib
Phase: 3
Study Start date:
February 28, 2025
Estimated Completion Date:
July 21, 2032

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  • Local Institution - 0122

    ABB, Ciudad Autónoma De Buenos Aires C1199ABB
    Argentina

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    Buenos Aires, Ciudad Autónoma De Buenos Aires C1118AAT
    Argentina

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    Camperdown, New South Wales 2050
    Australia

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  • Local Institution - 0190

    Liverpool, New South Wales 2170
    Australia

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  • Local Institution - 0140

    Brisbane, Queensland 4102
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    Adelaide, South Australia 5000
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    Clayton, Victoria 3168
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  • Local Institution - 0138

    Melbourne, Victoria 3000
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  • Local Institution - 0191

    Melbourne, Victoria 3004
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    Murdoch, Western Australia 6150
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  • Local Institution - 0167

    Linz, Oberösterreich 4020
    Austria

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  • Local Institution - 0166

    Vienna, 1140
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  • Local Institution - 0162

    Yvoir, Namur 5530
    Belgium

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    Gent, Oost-Vlaanderen 9000
    Belgium

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    Gent, Oost-Vlaanderen 9000
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    Belo Horizonte, Minas Gerais 30180-060
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    Sao Paulo, São Paulo 01509-010
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    Kanazawa, Ishikawa 920-8641
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    Osaka, 543-8555
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    Tokyo, 150-8935
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    Yamagata, 990-9585
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    Seoul, Seoul-teukbyeolsi [Seoul] 05505
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    Los Angeles, California 90404
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    Atlanta, Georgia 30322
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