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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.
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