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SNYSanofiRunning, no new patients

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

Plasma Cell Myeloma

0Calmworry score, out of 100

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

No warning signs right now. That's why the score is 0.

Score over time

Stage
Phase 3
Patients
337 (final count)
Started
Jun 16, 2020
Main results expected
Oct 14, 2030
Fully finished
Oct 21, 2033
Results posted
not yet

What counts as success

The trial's main goal(s), called the “primary outcome.”

  • Number of participants with Treatment-emergent adverse events (AEs) and serious adverse events- Safety Run-in Part

    Measured over: Up to approximately 63 months

  • Plasma concentration of isatuximab during the treatment period - Safety Run-in Part

    Measured over: After first infusion from Cycle 1 Day 1 to Day 28 in safety run-in part

  • Receptor density/receptor occupancy Safety Run-in Part

    Measured over: Baseline to Cycle 2 Day 1 (each cycle is 28 days)

  • Progression-free survival (PFS) Randomized Phase 3 Part

    Measured over: Up to approximately 114 months

Changes Tremor has spotted

No changes since Tremor started watching this trial.
Show details (technical version)

Score inputs

  • none

Raw record changes

  • none yet

Trial ID NCT04270409 · record last updated 2025-12-12 · checked 2026-11-09 15:47 UTC

See the official record on ClinicalTrials.gov (NCT04270409) ↗