A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide TRILOGY-5

What's the purpose of this trial?

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.

This trial is currently open and accepting patients.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion criteria:

* Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory
* Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication
* Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment

Exclusion criteria:

* Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
* Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients
* Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM
* Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

Additional Trial Information

Phase 3

Enrollment: 700 patients (estimated)

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Trial Locations

All Trial Locations

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Alabama

Alabama Oncology

Birmingham, AL

Open and Accepting

Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

Arkansas

Highlands Oncology Group (North Hills)

Fayetteville, AR

Open and Accepting

Highlands Oncology Group

Springdale, AR

Open and Accepting

California

Beverly Hills Cancer Center

Beverly Hills, CA

Open and Accepting

Valkyrie Clinical Trials

Los Angeles, CA

Open and Accepting

Florida

Memorial Cancer Institute Memorial Regional Hospital

Hollywood, FL

Open and Accepting

Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting

Memorial Cancer Institute Memorial Hospital West

Pembroke Pines, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Indiana

Franciscan Health Cancer Center Indianapolis

Indianapolis, IN

Open and Accepting

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and Accepting

Louisiana

Ochsner LSU Health Shreveport Ochsner Louisiana State University

Shreveport, LA

Open and Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

Karmanos Cancer Institute McLaren Greater Lansing

Lansing, MI

Open and Accepting

Minnesota

University of Minnesota - Masonic Cancer Center

Minneapolis, MN

Open and Accepting

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

Nebraska

Nebraska Cancer Specialists - Midwest Cancer Center Legacy Nebraska Cancer Specialists

Omaha, NE

Open and Accepting

New Jersey

Astera Cancer Care

East Brunswick, NJ

Open and Accepting

New Mexico

Christus St. Vincent Regional Medical Center

Santa Fe, NM

Open and Accepting

New York

New York Oncology Hematology - Albany Cancer Center

Albany, NY

Open and Accepting

New York Cancer and Blood Specialists

New York, NY

Open and Accepting

New York University Langone Medical Center Laura and Isaac Perlmutter Cancer Center

New York, NY

Open and Accepting

Perlmutter Cancer Center at NYU Langone Arena Oncology

North New Hyde Park, NY

Open and Accepting

New York Cancer and Blood Specialists

Riverhead, NY

Open and Accepting

Ohio

Gabrail Cancer Center Research

Canton, OH

Open and Accepting

The Christ Hospital

Cincinnati, OH

Open and Accepting

South Carolina

Saint Francis Hospital Cancer Center

Greenville, SC

Open and Accepting

Texas

Joe Arrington Cancer Research and Treatment Center Covenant Health

Lubbock, TX

Open and Accepting

Utah

Utah Cancer Specialists Cancer Center

Salt Lake City, UT

Open and Accepting
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