TRIlogy-5: A Study Comparing JNJ-79635322 and Teclistamab in Relapsed or Refractory Multiple Myeloma

The purpose of this study is to compare the effects of JNJ-79635322 against teclistamab. Teclistamab is already used to treat adults with multiple myeloma. JNJ-79635322 is an “investigational” drug, which means that it is not approved by the U.S. Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied. Therefore, it can only be used in a research study like this, and the results may be used to gain approvals.

If you agree to participate in this study, your participation may last up to about 5 and a half years (including the study treatment phase and follow-up phase). During these visits, you will be asked to have physical exams, receive the study drug(s), complete questionnaires about how you are feeling, and have lab (blood) and imaging tests done.

There are risks to you for participating in this study, some of which may be serious, may cause death, or may not go away. In this study, there is a risk of infections, changes to your blood counts, neurological side effects (like headaches, drowsiness, and/or abnormal sensations), stomach discomfort, and more.

In order to participate you must meet the following criteria:

• Have documented diagnosis of multiple myeloma (MM) as defined by the criteria below: 
  • MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria.
  • Measurable disease at screening as assessed by central laboratory.
• Have 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.

You will be excluded from the study if any of the following criteria apply to you:

• Have had 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.
• Have suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients.
• Have the presence of any of the following:
  • Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM).
  • Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy.
  • Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM.
• Have 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.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.