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

J

Juno Therapeutics

Status and phase

Enrolling
Phase 1

Conditions

Relapsed and/or Refractory Multiple Myeloma

Treatments

Drug: Cyclophosphamide
Drug: Fludarabine
Drug: BMS-986453

Study type

Interventional

Funder types

Industry

Identifiers

NCT06153251
CA119-0002

Details and patient eligibility

About

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

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 must have received at least 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

130 participants in 1 patient group

Administration of BMS-986453
Experimental group
Treatment:
Drug: BMS-986453
Drug: Fludarabine
Drug: Cyclophosphamide

Trial contacts and locations

18

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Central trial contact

First line of the email MUST contain the NCT# and Site#; BMS Study Connect www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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