MMRC Horizon Two: A Phase II Randomized Adaptive Platform Trial Integrating Novel Therapies in High-Risk-Newly Diagnosed Multiple Myeloma (MMRC-100)

The master protocol has broad scope and substantial flexibility, allowing each investigational arm within the platform to have its own design. The master protocol specifies general principles but the analysis plan for each investigational arm will be specified in its appendix. Details outlined in each investigational arm's appendix will include any co-primary endpoints (if applicable), the comparator arm, sample size and justification, inclusion of a safety run-in (if required), and any potential adaptations within the appendix. Accrual to an investigational arm will terminate in accord with i…