NIPH Clinical Trials Search

A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma ( TRIlogy-5 )

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Multiple Myeloma
Date of first enrollment	30/06/2026
Target sample size	700
Countries of recruitment	Australia,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,France,Japan,Germany,Japan,Greece,Japan,India,Japan,Israel,Japan,Italy,Japan,Republic Of Korea,Japan,Poland,Japan,Spain,Japan,Taiwan,Province Of China,Japan,Turkiye,Japan,United States Of America,Japan
Study type	Interventional
Intervention(s)	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). 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. Drug: Teclistamab Teclistamab will be administered as SC injection.

Outcome(s)

Primary Outcome

1. Complete Response (CR) or Better CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment. [Time Frame: Up to approximately 41 months] 2. Progression-Free Survival (PFS) PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria. [Time Frame: Up to approximately 41 months]

Secondary Outcome

See attached sheet

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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 screeningand within 1 day of the start of administration of study treatment
Exclude 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