Multiple Myeloma Clinical Trials

Multiple Myeloma Clinical Trials: Optimizing and Harmonizing Efficacy Endpoint Evaluation
The landscape of new therapies in multiple myeloma trials is rapidly evolving, with stringent global regulations around the evaluation of efficacy endpoints.
This white paper provides direction on how to harmonize an approach for meeting regulatory expectations by answering questions on how to overcome common challenges in myeloma clinical trials, including:
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- What are the acceptable modalities for evaluating the disease extent in a multiple myeloma patient?
- Can the same imaging modality which is used to evaluate plasmacytoma be used to identify bone lesions?
- What is the contribution of PET to response evaluation? Does metabolic response noted on PET override an anatomical response noted on CT/MRI?
- Can local lab data be used for response evaluation? What are the specific challenges if you allow that?
- And more…
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