N=~1594
contact details, please visit
ClinicalTrials.gov
Key eligibility criteria†:
- Newly diagnosed MM according to IMWG criteria with a history of only one line of therapy and achieving ≥PR
- ECOG PS 0–2
- No prior maintenance therapy or gene modified adoptive cell therapy
- No history of progression on MM therapy
Primary outcomes:
- PFS
- 12-month MRD-negative CR
Secondary outcomes‡:
- OS
- ≥CR and CR conversion
- MRD-negative CR, sustained MRD negativity, and MRD-negative conversion
- PFS2
- TTNT
- PK
- Safety
*Sponsored by the European Myeloma Network B. V., which is collaborating with Johnson & Johnson on this study. †Not a complete list of inclusion and exclusion criteria. ‡Not a complete list of secondary outcomes.
Ab, antibody; ASCT, autologous stem cell transplant; BCMA, B-cell maturation antigen; CD, cluster of differentiation; CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; IMWG, International Myeloma Working Group; MM, multiple myeloma; MRD, minimal residual disease; OS, overall survival; PFS, progression-free survival; PFS2, progression-free survival on next-line therapy; PK, pharmacokinetics; PO, orally; PR, partial response; PS, performance status; R, randomized; SC, subcutaneous; TTNT, time to next treatment.