Recent CAR-T trials in multiple myeloma primarily evaluate overall response rate (ORR) and duration of response (DOR) as primary endpoints. [1]
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The primary safety concerns include cytokine release syndrome (CRS) and neurological toxicities. Grade 3+ CRS occurred in 8–12% of patients across trials.[1]

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Phase 3 enrollment completed in Q3. Primary endpoint data expected Q1 2025. [1]
Regulatory submission planned for late 2027
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Latest FDA guidance on accelerated approval pathways emphasizes surrogate endpoints validation. [1] Page 12
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Analysis of health economic models across payers.
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