NCT04458831Completed
A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 583 (actual)
- First submitted
- 25 Jun 2020
- Start date
- 13 Aug 2020
- Primary completion date
- 23 Feb 2026
- Lead sponsor
- Sanofi
- Diseases
- Multiple myeloma
- NCT number
- NCT04458831
What you commit to
- Study type: Observational
- Participants enrolled: 583
- From 13 Aug 2020 to the primary completion date, 23 Feb 2026
- 129 sites in 21 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Age ≥18 years or country's legal age of majority if the legal age is \>18 years old at the time of enrollment
- Patients with RRMM who have at least one prior line of therapy
- Patients for whom the treating physician has made the decision to initiate isatuximab per routine practice and independently of the purpose of the study; for retrospectively enrolled patients, exposure to isatuximab treatment for a maximum of three months prior to study enrollment
- Able to understand and complete the study-related questionnaires
- Patient must have given signed informed consent prior to study start. For retrospectively enrolled patients who are deceased at the date of enrollment into the study, a waiver of consent will be required; patients who have started and stopped treatment or whose treatment is still ongoing at ICF are eligible
- Most important exclusion criteria for potential participants:
- Patients who are receiving isatuximab for an indication other than RRMM
- Patients who have received any other investigational drug or prohibited therapy for this study within 28 days or five half-lives from randomization, whichever is longer
- Patients having contraindication to the isatuximab summary of product characteristics (SMPC) or package insert (PI)
- Patients having contraindications as noted in the drug-specific local isatuximab SMPC/PI of combination drugs
- Any country-related specific regulation that would prevent the patient from entering the study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Further eligibility criteria might apply.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (129)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Unknown status |
| - Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Unknown status |
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Pilar | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Steyr | Austria | Unknown status |
| Institut Jules Bordet - Investigational Site Number : 0560001 Coordinator of this site? Confirm its status | Anderlecht | Belgium | Unknown status |
| - Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Unknown status |
| Kantonsspital Baden AG - Investigational Site Number : 5760003 Coordinator of this site? Confirm its status | Baden | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Stadtspital Triemli - Investigational Site Number : 5760002 Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| - Coordinator of this site? Confirm its status | Aschaffenburg | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Bamberg | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Bayreuth | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Praxis am Volkspark - Investigational Site Number : 2760009 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| MV Zentrum für Onkologie und Hämatologie - Investigational Site Number : 2760034 Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Donauwörth | Germany | Unknown status |
| GEFOS Gesellschaft f. onkologische Studien -Investigational Site Number : 2760001 Coordinator of this site? Confirm its status | Dortmund | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus - Investigational Site Number : 2760010 Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Herrsching am Ammersee | Germany | Unknown status |
| Klinikum Kulmbach mit Fachklinik Stadtsteinach - Investigational Site Number : 2760026 Coordinator of this site? Confirm its status | Kulmbach | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Philipps-Universitat Marburg, Klinic fur Innere Medizin -Investigational Site Number : 2760038 Coordinator of this site? Confirm its status | Marburg | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042 Coordinator of this site? Confirm its status | Mutlangen | Germany | Unknown status |
| Dietrich-Bonhoeffer-Klinikum - Investigational Site Number : 2760044 Coordinator of this site? Confirm its status | Neubrandenburg | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Oldenburg | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Oldenburg | Germany | Unknown status |
| Klinikum Ernst von Bergmann gGmbH -Investigational Site Number : 2760039 Coordinator of this site? Confirm its status | Potsdam | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Stolberg | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Weilheim | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Hospital Universitario Virgen de la Nieves - Investigational Site Number : 7240010 Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Complejo Asistencial Universitario de Leon Altos de Nava s/n. -Investigational Site Number : 7240005 Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hospital Regional Universitario de Malaga Hospital Regional Universitario de Malaga - Investigational Site Number : 7240006 Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitari Son Espases - Investigational Site Number : 7240003 Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Hospital Universitario de Navarra - Investigational Site Number : 7240009 Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Complejo Hospitalario Universitario de Pontevedra - Investigational Site Number : 7240011 Coordinator of this site? Confirm its status | Pontevedra | Spain | Unknown status |
| omplejo Hospitalario Universitario de Canarias - Investigational Site Number : 7240007 Coordinator of this site? Confirm its status | San Cristóbal de La Laguna | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Toledo | Spain | Unknown status |
| Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007 Coordinator of this site? Confirm its status | Argenteuil | France | Unknown status |
| - Coordinator of this site? Confirm its status | Cahors | France | Unknown status |
| Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006 Coordinator of this site? Confirm its status | Chambéry | France | Unknown status |
| Clinique Louis Pasteur, Maison Médicale - Investigational Site Number : 2500012 Coordinator of this site? Confirm its status | Essey-lès-Nancy | France | Unknown status |
| Centre Hospitalier Le Mans - Investigational Site Number : 2500015 Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| - Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| - Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| - Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| CHU Poitiers - Hôpital la Milétrie - Investigational Site Number : 2500008 Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| CHU Reims - Hôpital Robert Debré - Investigational Site Number : 2500010 Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| - Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| - Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| - Coordinator of this site? Confirm its status | Saint-Quentin | France | Unknown status |
| - Coordinator of this site? Confirm its status | Tarbes | France | Unknown status |
| - Coordinator of this site? Confirm its status | Vannes | France | Unknown status |
| - Coordinator of this site? Confirm its status | Huddersfield | United Kingdom | Unknown status |
| Freeman Hospital - Investigational Site Number : 8260003 Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Piraeus | Greece | Unknown status |
| - Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Unknown status |
| - Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Istituto di Ematologia e Oncologia Medica - Investigational Site Number : 3800005 Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800007 Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliera Universitaria "Federico II"-Investigational Site Number : 3800001 Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Policlinico Umberto I - Investigational Site Number : 3800002 Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800009 Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Trento | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Treviso | Italy | Unknown status |
| - Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Minatoku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Osakasayama-shi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Shibukawa-shi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Sunto-gun | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Suwa-shi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Yamagata | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kuwait City | Kuwait | Unknown status |
| Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001 Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Unknown status |
| Puerto Rico Medical Research Center, LLC Site Number : 8400001 Coordinator of this site? Confirm its status | Hato Rey | Puerto Rico | Unknown status |
| Auxilio Mutuo Cancer Center Site Number : 8400029 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| - Coordinator of this site? Confirm its status | Volgograd | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Unknown status |
| - Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Unknown status |
| - Coordinator of this site? Confirm its status | Khobar | Saudi Arabia | Unknown status |
| - Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| - Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Hematology & Oncology Associates Site Number : 8400015 Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Charleston Hematology Oncology Associates, PA Site Number : 8400020 Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Michigan Center of Medical Research Site Number : 8400010 Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| Holy Cross Hospital Site Number : 8400030 Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017 Coordinator of this site? Confirm its status | Freehold | United States | Unknown status |
| St. Joseph Heritage Healthcare Site Number : 8400008 Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Central Care Cancer Center Site Number : 8400006 Coordinator of this site? Confirm its status | Garden City | United States | Unknown status |
| Central Care Cancer Center Site Number : 8400019 Coordinator of this site? Confirm its status | Garden City | United States | Unknown status |
| Prisma Health - Eastside Office Site Number : 8400011 Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| MD Anderson Cancer Center Site Number : 8400013 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Regional Cancer Care Associates Site Number : 8400024 Coordinator of this site? Confirm its status | Howell Township | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Watson Clinic Cancer and Research Center Site Number : 8400023 Coordinator of this site? Confirm its status | Lakeland | United States | Unknown status |
| Central Maine Medical Center Site Number : 8400031 Coordinator of this site? Confirm its status | Lewiston | United States | Unknown status |
| University of Arkansas Medical Sciences Site Number : 8400021 Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Regional Cancer Care Associates - Little Silver Division Site Number : 8400018 Coordinator of this site? Confirm its status | Little Silver | United States | Unknown status |
| Tri County Hematology & Oncology Associates, Inc Site Number : 8400012 Coordinator of this site? Confirm its status | Massillon | United States | Unknown status |
| Millennium Oncology Site Number : 8400025 Coordinator of this site? Confirm its status | Pembroke Pines | United States | Unknown status |
| University of California San Francisco (PARENT) Site Number : 8400009 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Comprehensive Hematology Oncology Site Number : 8400026 Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| - Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Prairie Lakes Health Care System, Inc Site Number : 8400002 Coordinator of this site? Confirm its status | Watertown | United States | Unknown status |
| Novant Health Forsyth Medical Center Site Number : 8400028 Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.