TRI Pro*
Multiple myeloma
A Phase 2, randomized, double-blind study evaluating the prophylactic use of tocilizumab to prevent cytokine release syndrome with ramantamig (JNJ-79635322) administration in participants with relapsed or refractory MM
Phase
Compound
Ramantamig (JNJ-79635322; BCMA × GPRC5D × CD3 trispecific Ab) ± tocilizumab
NCT identifier
NCT07589634
Enrollment
N=~230
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria†:
Relapsed or refractory MM
- ≥1 prior lines of antimyeloma therapy
- ECOG PS 0–2
- No concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent
- No known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM
Study
design
Primary outcome:
- Safety
Secondary outcomes‡:
- Safety
- ORR
- ≥CR
- ≥VGPR
- DOR
- TTR
- PFS
- TTNT
*Soon to be recruiting. †Not a complete list of inclusion and exclusion criteria. ‡Not a complete list of outcomes.
Ab, antibody; BCMA, B-cell maturation antigen; CD, cluster of differentiation; CNS, central nervous system; CR, complete response; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GPRC5D, G protein–coupled receptor class C group 5 member D; MM, multiple myeloma; ORR, overall response rate; PFS, progression-free survival; R, randomized; TTNT, time to next line of therapy; TTR, time to response; VGPR, very good partial response.