A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 05 Nov 2024

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At a glance

Drugs Isatuximab (Primary) ; Dexamethasone; Dexamethasone; Lenalidomide
Indications Smoldering multiple myeloma
Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
Acronyms ITHACA
Sponsors Sanofi

Most Recent Events

31 Oct 2024 Planned End Date changed from 10 Oct 2033 to 21 Oct 2033.
31 Oct 2024 Planned primary completion date changed from 11 Nov 2030 to 14 Oct 2030.
07 Mar 2024 Planned primary completion date changed from 1 Jun 2028 to 11 Nov 2030.

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