Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of CC-95266 in participants with relapsed and/or refractory multiple myeloma (R/R MM).

Official Title

A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Keywords

Multiple Myeloma CC-95266 Relapsed and/or Refractory Neoplasms, Plasma Cell Cyclophosphamide Fludarabine Administration of CC-95266

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥ 18 years
  • Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease Participants must have documented progressive disease on or within 12 months of completing treatment with the last anti-myeloma treatment regimen, except for participants with cellular therapy (eg, Chimeric antigen receptor (CAR) T-cell therapy) as their last treatment, who may enroll beyond 12 months
  • Participants must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without hematopoietic stem cell transplant (HSCT) and with or without maintenance therapy is considered one regimen), including:
  • Autologous stem cell transplant
  • A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination
  • Anti-CD38 (eg, daratumumab), either alone or combination
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function

You CAN'T join if...

  • Known active or history of central nervous system (CNS) involvement of MM
  • Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis
  • Active autoimmune disease requiring immunosuppressive therapy
  • History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis

Other protocol-defined inclusion/exclusion criteria apply

Locations

  • University of California, San Francisco Comprehensive Cancer Center not yet accepting patients
    San Francisco California 94143 United States
  • City of Hope accepting new patients
    Duarte California 91010-301 United States
  • City Of Hope accepting new patients
    Duarte California 91010-301 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Juno Therapeutics, a Subsidiary of Celgene
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls Investigator Inquiry Form
ID
NCT04674813
Phase
Phase 1 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 77 study participants
Last Updated