International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Sanofi
Study ID
NCT05669989
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Plasma Cell Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Isatuximab intravenous (IV) — DRUG
    Route of administration: IV infusion; Pharmaceutical form: Vial
  • Cemiplimab (SAR439684) — DRUG
    Route of administration: IV infusion; Pharmaceutical form: Vial
  • Dexamethasone — DRUG
    Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial
  • Lenalidomide — DRUG
    Route of administration: Oral; Pharmaceutical form: Capsules
  • Pomalidomide — DRUG
    Route of administration: Oral; Pharmaceutical form: Hard capsules
  • Isatuximab subcutaneous (SC) — DRUG
    Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial
  • Carfilzomib — DRUG
    Route of administration: IV infusion; Pharmaceutical form: Vial

Study Details

* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. * The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

Key Dates

Start date
Apr 5, 2023
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Isatuximab
    Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol

Primary Outcome Measure

Number of participants with treatment-emergent adverse events [ Time Frame: Baseline to 42 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University- Site Number : 8400001St LouisMissouri63110-

Find similar trials in St Louis, MO

By research site
Washington University· St Louis, MO

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