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

Purpose

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.

Condition

  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
JNJ-79635322
Participants will receive JNJ-79635322 as an injection under the skin.
  • Drug: JNJ-79635322
    JNJ-79635322 will be administered as an injection under the skin.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com