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A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

NCT04458831 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 583

Last updated 2025-06-27

No results posted yet for this study

Summary

Primary Objective:

To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months

To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice

To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice

To describe safety of isatuximab in routine clinical practice (based on adverse event \[AE\] reporting)

To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20)

Secondary Objective:

Not applicable

Conditions

  • Plasma Cell Myeloma

Interventions

DRUG

isatuximab SAR650984

Pharmaceutical form: solution for infusion Route of administration: intravenous

DRUG

Pomalidomide

Pharmaceutical form: oral

DRUG

Dexamethasone

Pharmaceutical form: oral

DRUG

Carfilzomib

Pharmaceutical form: solution for infusion

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2026-02-23
Completion
2026-02-23

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • China
  • France
  • Germany
  • Greece
  • Hong Kong
  • Italy
  • Japan
  • Kuwait
  • Netherlands
  • Puerto Rico
  • Russia
  • Saudi Arabia
  • Spain
  • Switzerland
  • Taiwan
  • United Arab Emirates
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT04458831 on ClinicalTrials.gov