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REGNRegeneron PharmaceuticalsFinished

First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)

Relapsed Multiple Myeloma · Refractory Multiple Myeloma

15Calmworry score, out of 100

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

Why this score

  • Main results were due May 2025, none posted yet

    Counts until it's fixed

    +10
  • 5 insiders sold shares within a month

    Since Nov 4, 2026 · was worth 5, fading over time

    +4.8
Worry score15

Score over time

Stage
Phase 1/2
Patients
43 (final count)
Started
Sep 26, 2019
Main results expected
May 1, 2025
Fully finished
May 1, 2025
Results posted
not yet

What counts as success

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

  • Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period

    Measured over: Up to 35 Days

  • Incidence and severity of treatment-emergent adverse events (TEAEs) during REGN5459 treatment period

    Measured over: Up to 12 Weeks After the Last Dose

  • Incidence and severity of adverse events of special interest (AESI) with REGN5459 treatment period

    Measured over: Up to 12 Weeks After the Last Dose

  • Objective response rate (ORR) as measured using the International Myeloma Working Group (IMWG) criteria

    Measured over: Up to Approximately 104 Weeks

Changes Tremor has spotted

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

Score inputs

  • results_overdue: base 10, now 10, since 2025-05-01, no fading
  • insider_selling_cluster: base 5, now 4.8, since 2026-11-04, fades (half-life)

Raw record changes

  • none yet

Trial ID NCT04083534 · record last updated 2026-05-04 · checked 2026-11-09 15:47 UTC

See the official record on ClinicalTrials.gov (NCT04083534) ↗