Trial Design in Motion: Choosing the Right Comparator in a Rapidly Evolving Multiple Myeloma Landscape
Multiple myeloma clinical trials are evolving faster than traditional trial design frameworks can accommodate. As CAR-T therapies, bispecific antibodies and next-generation immune targets rapidly reshape the standard of care (SoC), sponsors face increasing complexity in selecting appropriate comparator arms, aligning regulatory strategy and designing sustainable oncology clinical trials.
In this Insights Hub perspective, Syneos Health experts examine how comparator selection in multiple myeloma has become a strategic determinant of early-phase and late-phase oncology drug development success. With heterogeneous real-world treatment patterns, shifting SoC pathways and evolving regulatory expectations, static trial designs risk becoming outdated before readout.
The article explores how biotechs and pharmaceutical companies can:
- Select clinically credible and regulator-acceptable comparator arms in multiple myeloma
- Integrate regulatory intelligence with feasibility assessments across global regions
- Design adaptive oncology trials aligned with ICH E6(R3) guidance
- Incorporate modular protocol architecture, adaptive randomization and external control strategies
- Future-proof early-phase oncology programs against rapidly shifting treatment landscapes
For emerging and mid-size biotechs entering the multiple myeloma space, this perspective outlines how integrated clinical development strategy, regulatory insight and operational intelligence can reduce protocol amendments, preserve interpretability at readout and accelerate oncology drug development timelines.
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