Akademik Veri Yönetim Sistemi
Yağcı A. M. (Yürütücü)
Diğer Ülkelerin Sanayi Kuruluşları Tarafından Desteklenmiş Proje, 2024 - 2030
The study includes:
• A screening period of up to 28 days
• A treatment period as outlined below:
oFor participants in Part 1 (Safety Run-In): Odronextamab + lenalidomide treatment will consist of 12 cycles (each cycle being of 28-day duration) until relapse, progressive disease, withdrawal of consent or unacceptable toxicity. For participants in Part 2 (Randomized Part): In Arm 1, participants will receive 12 cycles of odronextamab in combination with lenalidomide, each cycle being of 28- day duration. In Arm 2, participants will receive combination therapy with R2 for 5 cycles followed by lenalidomide monotherapy for the remaining 7 cycles .
• Clinical Follow-Up (Part 1 and Part 2): a follow-up visit at 90 days (±7 days) after the last dose of assigned study treatment, or until the start of next non-protocol anti-lymphoma therapy for safety assessments. Efficacy assessments will continue as planned, every 12 weeks (±7 days) from start of study treatment, until disease progression, withdrawal of consent, loss to follow-up, death, start
of next anti-lymphoma treatment or end of study, whichever is earliest. Participants who discontinue study treatment for reasons other than disease progression or withdrawal of consent should
continue in the clinical follow-up until discontinuation, death, withdrawal of consent, loss to follow-up, or study termination by the sponsor, whichever is earlier. Additional SAE reporting fo related events will be collected for the duration of clinical follow-up.
• Survival Follow-Up: survival status collected every 12 weeks will
apply for participants who end clinical follow-up, and it will
continue until death, withdrawal of consent, loss to follow-up (ie,
study participant can no longer be contacted or have the survival
status verified by the investigator) or study termination by the
sponsor, whichever is earlier.