The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (TRIlogy-5)
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
Relapsed or refractory myeloma
All genders
18+
Recruiting now
Overview
Principal Investigator: Parva Bhatt, MD
Contact Us
Latoya Marshall
Study details
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.
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.
Study Requirements
Experimental: Arm A: JNJ-79635322
Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first).
Intervention/Treatment: Drug: JNJ-79635322. JNJ-79635322 will be administered as SC injection.
Active Comparator: Arm B: Teclistamab
Participants will receive teclistamab as a SC injection until PD or intolerable toxicity.
Intervention/Treatment: Drug: Teclistamab. Teclistamab will be administered as SC injection.