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NCT Number: NCT06153251

A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease.
  • Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.
  • Participants in Part A and Part B Cohort 1 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participants must have adequate organ function.

Exclusion criteria

  • Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.
  • Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.
  • Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.
  • Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986453

Drug

Specified dose on specified days

Fludarabine

Drug

Specified dose on specified days

Other names: FludAra, Oforta

Cyclophosphamide

Drug

Specified dose on specified days

Other names: Cytoxan, Cytoxan Lyophilized, Neosar

Primary outcomes

  1. Number of participants with treatment-emergent adverse events (AEs)

    Time frame: Up to 4 years

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 4 years

  3. Number of participants with AEs leading to discontinuation

    Time frame: Up to 4 years

  4. Number of participants with AEs leading to death

    Time frame: Up to 4 years

  5. Number of participants with dose-limiting toxicities (DLTs)

    Time frame: Up to 4 years

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to 4 years

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to 4 years

  3. Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))

    Time frame: Up to 4 years

  4. Overall response rate (ORR)

    Time frame: Up to 4 years

  5. Complete response rate (CRR)

    Time frame: Up to 4 years

  6. Number of participants with very good partial response (VGPR) or better

    Time frame: Up to 4 years

  7. Progression-free survival (PFS)

    Time frame: Up to 4 years

  8. Overall survival (OS)

    Time frame: Up to 4 years

  9. Time to response (TTR)

    Time frame: Up to 4 years

  10. Time to complete response (TTCR)

    Time frame: Up to 4 years

  11. Duration of response (DOR)

    Time frame: Up to 4 years

  12. Duration of complete response (DOCR)

    Time frame: Up to 4 years

  13. Persistence of BMS-986453 in peripheral blood

    Time frame: Up to 4 years

    Defined as a transgene count greater than or equal to the lower limit of detection (LLOD)

  14. Expansion rate

    Time frame: Up to 4 years

    Defined as Cmax divided by Tmax

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Industry

Registry information

Official study title

A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Dec 1, 2023
Registry last updated
Mar 18, 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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