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Be Part of Research - Trial Details - A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

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

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Multiple Myeloma
Neoplasms, Plasma Cell


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2020 Feb 2026

OBSERVATIONAL

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: solution for infusion

Route of administration: intravenous

Intervention Arm Group : Cohort 1;

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: oral

Intervention Arm Group : Cohort 1;

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: oral

Intervention Arm Group : Cohort 1;

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: solution for infusion

Intervention Arm Group : Cohort 1;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Investigational Site Number : 8260002
    Nottingham
    Nottinghamshire
    NG5 1PB
  • Investigational Site Number : 8260005
    Sutton
    Surrey
    SM2 5PT
  • Freeman Hospital - Investigational Site Number : 8260003
    Newcastle Upon Tyne
    NE7 7DN
  • Huddersfield Royal Infirmary - Investigational Site Number : 8260004
    Huddersfield
    HD3 3EA


The study is sponsored by Sanofi




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Read full details for Trial ID: NCT04458831
Last updated 21 March 2025

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