Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

The purpose of this study is to evaluate how well JNJ-79635322 works (efficacy) in participants with Relapsed or Refractory Multiple Myeloma (RRMM; a cancer that forms in a type of white blood cells called a plasma cell. Cancer is called relapsed if it comes back after treatment and is called 'refractory' if does not respond to treatment) who have received at least 3 prior lines of therapy.

Official Title

A Phase 2, Open-label Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody

Keywords

Multiple Myeloma, JNJ-79635322

Eligibility

For people ages 18 years and up

Inclusion:

  • Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:
    1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
    2. Measurable disease at screening as assessed by central laboratory
  • Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD) 38 monoclonal antibody (mAb)
  • Documented evidence of progressive disease(PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by the IMWG criteria
  • Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent
  • Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 to 2 at screening and immediately before the start of study treatment administration

Exclusion:

  • Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322
  • Had major surgery within 2 weeks before first dose or has planned major surgery during study treatment phase
  • Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
  • Participant has leptomeningeal disease
  • Participant has a prior or concurrent second malignancy the natural history or treatment of which could likely interfere with any study endpoints of safety or the efficacy of the study treatment

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • City of Hope Orange County Lennar Foundation Cancer Center accepting new patients
    Irvine California 92618 United States
  • Cancer and Blood Specialty Clinic accepting new patients
    Los Alamitos California 90720 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT07266441
Phase
Phase 2 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 157 study participants
Last Updated