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Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients

NCT02812706 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-04-01

Study results available
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Summary

Primary Objectives:

* Phase I: To evaluate safety and tolerability of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.
* Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.

Secondary Objectives:

* To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events were assessed.
* To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule.
* To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria.
* To assess the relationship between Baseline cluster of differentiation 38 (CD38) receptor density on multiple myeloma cells and efficacy.

Conditions

Interventions

DRUG

Isatuximab SAR650984

Pharmaceutical form: solution Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-05
Primary Completion
2018-07-31
Completion
2022-09-28

Countries

  • Japan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02812706 on ClinicalTrials.gov