Case Study – Hemato-Oncology Multiple Myeloma

Discover how our experts helped our sponsor set up a randomized, open-label, multicentre Phase 3 study to compare progression-free survival upon two different combination therapies (with a targeted MoA) in patients with relapsed or refractory multiple myeloma. 

See how we were able to handle: 

• aggressive study timelines
• frequent changes to the protocol
• the adding CD138+, FISH, and cell clonality added after the study started
• Japan added as a separate study later as well
• the sponsor monitored TAT closely and wanted centralized genomics testing and aggregate reporting.