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Phase III Randomized Study Comparing JNJ-79635322 versus Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma who Have Received 1-3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide

UCI Specialty Area: Cancer
Principal Investigator: Kamyar Nader
A Study On:
Multiple Myeloma

Study Description

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

Eligibility

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

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
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