Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Part of paid clinical trials in Denver, Colorado.

Sponsor
Sanofi
Study ID
NCT03194867
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Plasma Cell Myeloma

Eligibility Criteria

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

Interventions

  • Isatuximab SAR650984 — DRUG
    Pharmaceutical form: solution for infusion Route of administration: intravenous
  • Cemiplimab REGN2810 — DRUG
    Pharmaceutical form: solution for infusion Route of administration: intravenous

Study Details

Primary Objectives: * To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma. * To compare the overall response of the combination of isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria. Secondary Objectives: * To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS). * To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in combination. * To assess the immunogenicity of isatuximab and cemiplimab when given in combination.

Key Dates

Start date
Feb 21, 2018
Status verified
May 2024
Primary completion
Apr 5, 2023
Completion
Apr 5, 2023

Study Design

Enrollment
109 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Isatuximab/cemiplimab (Regimen 1)
    Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression. Cemiplimab on Days 1 and 15 in 28-day cycle up to disease progression.
  • Experimental: Isatuximab/cemiplimab (Regimen 2)
    Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression. Cemiplimab on Day 1 in 28-day cycle up to disease progression.
  • Active Comparator: Isatuximab
    Isatuximab on Days 1, 8, 15 and 22, then Day 1 and 15 in 28-day cycles up to disease progression.

Primary Outcome Measure

Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 Day 1 to Day 28 ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Colorado-Site Number:8400001DenverColorado80262-
University of Kansas Medical Center-Site Number:8400003Kansas CityKansas66160-7321-
Memorial Sloan-Kettering Cancer Center-Site Number:8400002New YorkNew York10021-
Fox Chase Cancer Center-Site Number:8400004PhiladelphiaPennsylvania19111-

Find similar trials in Denver, CO

By research site
University of Colorado· Denver, COUniversity of Kansas Medical Center· Kansas City, KSMemorial Sloan-Kettering Cancer Center· New York, NYFox Chase Cancer Center· Philadelphia, PA

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