discover how our experts performed a randomised, 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.
During this study the sponsor had set aggressive study timelines and there were frequent changes to the protocol such as cd138+, FISH, and cell clonality added after the study start. In the same way, Japan added as a separate study later as well. The sponsor monitored the TAT closely and wanted centralized genomics testing and aggregate reporting.
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Case Study on Multiple Myeloma
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