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A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

RecruitingPhase 2

Sponsor: Janssen Research & Development, LLC

Conditions: Multiple Myeloma

Interventions: JNJ-79635322

Countries: United States, China, Israel, Italy, Japan, Poland, South Korea, Turkey (Türkiye)

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (71)

Birmingham, Alabama, United States
Gilbert, Arizona, United States
Duarte, California, United States
Irvine, California, United States
Los Alamitos, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
O'Fallon, Illinois, United States
Iowa City, Iowa, United States
Waukee, Iowa, United States
Boston, Massachusetts, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Eugene, Oregon, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Tyler, Texas, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Tacoma, Washington, United States
+ 41 more on CT.gov