A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
- Conditions
- Plasma Cell Myeloma
- Interventions
- Registration Number
- NCT04458831
- Lead Sponsor
- Sanofi
- Brief 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
- Detailed Description
Duration per participant is 2.5 years
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 586
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 isatuximab SAR650984 Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria Cohort 1 Dexamethasone Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria Cohort 1 Carfilzomib Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria Cohort 1 Pomalidomide Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) 12 months The proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by investigator using the IMWG response criteria
Progression free survival (PFS) up to 18 months Time from isatuximab start date to the date of first documentation of progressive disease (PD) (as determined by the investigator) or the date of death from any cause, whichever comes first.
Progression free survival rate (PFSR) up to 18 months The proportion of patients who do not progress and are alive at specific time intervals
Duration of response (DoR) 12 months Time from the date of the first response for patients achieving partial response (PR) 4 or better (PR , VGPR , CR , or sCR to the date of first documented PD (as determined by Investigator using the IMWG response criteria) or death, whichever happens first.
Time to first subsequent anti-myeloma therapy 30 months Time from the initiation of isatuximab until the start of subsequent therapy or death.
Rate of complete response (CR) or better up to 12 months Comprising CR and sCR responses within 12 months
Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20) through end of treatment (up to approximately 2 years) The EORTC QLQ-MY20 is a validated, self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item).
Time to response (TTR) 12 months Defined as the time between isatuximab start date and the onset of first response for patients achieving PR or better (sCR, CR, VGPR, or PR) assessed by investigator using the IMWG response criteria
Rate of very good partial response or better up to 12 months Comprising VGPR, CR, and sCR within 12 months
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the Quality of Life 30 item core questionnaire (QLQ-C30) through end of treatment (up to approximately 2 years) The EORTC QLQ-C30 is a brief self- or interviewer-administered patient-reported survey. This 30-item questionnaire measures the following domains: 1) global health status/QoL; 2) functional scales including physical, role, emotional, cognitive, and social functioning; and 3) symptom scales/items related to fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact.
Number of Participants with Adverse events 1 month after end of treatment Adverse events (AE) including treatment emergent adverse events (TEAE), serious adverse events (SAE) and adverse events of special interest (AESIs) according to the following parameters: associated reactions (IARs), pregnancy in a patient (or partner of a patient), symptomatic overdose, occurrence of a second malignancy, and/or neutropenia. TEAEs are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the TEAE period infusion
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (129)
Investigational Site Number : 2760003
🇩🇪Berlin, Germany
Investigational Site Number : 2760041
🇩🇪Berlin, Germany
Investigational Site Number : 2500011
🇫🇷Vannes Cedex, France
Investigational Site Number : 2760016
🇩🇪Aschaffenburg, Germany
Investigational Site Number : 2760020
🇩🇪Bamberg, Germany
Investigational Site Number : 2760018
🇩🇪Bayreuth, Germany
University of Arkansas Medical Sciences Site Number : 8400021
🇺🇸Little Rock, Arkansas, United States
St. Joseph Heritage Healthcare Site Number : 8400008
🇺🇸Fullerton, California, United States
University of California San Francisco (PARENT) Site Number : 8400009
🇺🇸San Francisco, California, United States
Holy Cross Hospital Site Number : 8400030
🇺🇸Fort Lauderdale, Florida, United States
GenesisCare Site Number : 8400007
🇺🇸Jacksonville, Florida, United States
Watson Clinic Cancer and Research Center Site Number : 8400023
🇺🇸Lakeland, Florida, United States
Millennium Oncology Site Number : 8400025
🇺🇸Pembroke Pines, Florida, United States
Comprehensive Hematology Oncology Site Number : 8400026
🇺🇸Saint Petersburg, Florida, United States
Central Care Cancer Center Site Number : 8400019
🇺🇸Garden City, Kansas, United States
Central Maine Medical Center Site Number : 8400031
🇺🇸Lewiston, Maine, United States
Michigan Center of Medical Research Site Number : 8400010
🇺🇸Farmington Hills, Michigan, United States
Central Care Cancer Center Site Number : 8400006
🇺🇸Garden City, Missouri, United States
AMR Kansas City Site Number : 8400016
🇺🇸Kansas City, Missouri, United States
Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017
🇺🇸Freehold, New Jersey, United States
Regional Cancer Care Associates Site Number : 8400024
🇺🇸Howell, New Jersey, United States
Regional Cancer Care Associates - Little Silver Division Site Number : 8400018
🇺🇸Little Silver, New Jersey, United States
Novant Health Forsyth Medical Center Site Number : 8400028
🇺🇸Winston-Salem, North Carolina, United States
Hematology & Oncology Associates Site Number : 8400015
🇺🇸Canton, Ohio, United States
Tri County Hematology & Oncology Associates, Inc Site Number : 8400012
🇺🇸Massillon, Ohio, United States
Charleston Hematology Oncology Associates, PA Site Number : 8400020
🇺🇸Charleston, South Carolina, United States
Prisma Health - Eastside Office Site Number : 8400011
🇺🇸Greenville, South Carolina, United States
Prairie Lakes Health Care System, Inc Site Number : 8400002
🇺🇸Watertown, South Dakota, United States
MD Anderson Cancer Center Site Number : 8400013
🇺🇸Houston, Texas, United States
Renovatio Clinical Site Number : 8400004
🇺🇸The Woodlands, Texas, United States
Investigational Site Number : 0320001
🇦🇷Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Investigational Site Number : 0320006
🇦🇷Pilar, Buenos Aires, Argentina
Investigational Site Number : 0320004
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320005
🇦🇷Cordoba, Argentina
Investigational Site Number : 0320002
🇦🇷Cordoba, Argentina
LKH Steyr - Investigational Site Number : 0400002
🇦🇹Steyr, Austria
Institut Jules Bordet - Investigational Site Number : 0560001
🇧🇪Anderlecht, Belgium
AZ Nikolaas - Investigational Site Number : 0560002
🇧🇪Sint Niklaas, Belgium
Investigational Site Number : 1560002
🇨🇳Guangzhou, China
Investigational Site Number : 1560001
🇨🇳Shenzhen, China
Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007
🇫🇷Argenteuil, France
Investigational Site Number : 2500017
🇫🇷Cahors, France
Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006
🇫🇷Chambéry, France
Clinique Louis Pasteur, Maison Médicale - Investigational Site Number : 2500012
🇫🇷Essey les Nancy, France
Centre Hospitalier Le Mans - Investigational Site Number : 2500015
🇫🇷Le Mans Cedex, France
Investigational Site Number : 2500013
🇫🇷Lille, France
Investigational Site Number : 2500004
🇫🇷Montpellier Cedex 5, France
Investigational Site Number : 2500009
🇫🇷Pessac cedex, France
CHU Poitiers - Hôpital la Milétrie - Investigational Site Number : 2500008
🇫🇷Poitiers, France
CHU Reims - Hôpital Robert Debré - Investigational Site Number : 2500010
🇫🇷Reims, France
Investigational Site Number : 2500001
🇫🇷Rouen, France
Investigational Site Number : 2500005
🇫🇷Saint Priest En Jarez, France
Investigational Site Number : 2500014
🇫🇷Saint Quentin cedex, France
Investigational Site Number : 2500016
🇫🇷Tarbes, France
Praxis am Volkspark - Investigational Site Number : 2760009
🇩🇪Berlin, Germany
Investigational Site Number : 2760022
🇩🇪Berlin, Germany
Investigational Site Number : 2760007
🇩🇪Donauwoerth, Germany
GEFOS Gesellschaft f. onkologische Studien -Investigational Site Number : 2760001
🇩🇪Dortmund, Germany
Investigational Site Number : 2760002
🇩🇪Dresden, Germany
Investigational Site Number : 2760035
🇩🇪Dresden, Germany
Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus - Investigational Site Number : 2760010
🇩🇪Frankfurt am Main, Germany
Investigational Site Number : 2760037
🇩🇪Frankfurt, Germany
Investigational Site Number : 2760012
🇩🇪Hannover, Germany
Investigational Site Number : 2760013
🇩🇪Herrsching, Germany
MV Zentrum für Onkologie und Hämatologie - Investigational Site Number : 2760034
🇩🇪Koeln, Germany
Klinikum Kulmbach mit Fachklinik Stadtsteinach - Investigational Site Number : 2760026
🇩🇪Kulmbach, Germany
Investigational Site Number : 2760008
🇩🇪Leipzig, Germany
Philipps-Universitat Marburg, Klinic fur Innere Medizin -Investigational Site Number : 2760038
🇩🇪Marburg, Germany
Investigational Site Number : 2760006
🇩🇪Muenchen, Germany
Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042
🇩🇪Mutlangen, Germany
Dietrich-Bonhoeffer-Klinikum - Investigational Site Number : 2760044
🇩🇪Neubrandenburg, Germany
Investigational Site Number : 2760021
🇩🇪Oldenburg, Germany
Investigational Site Number : 2760036
🇩🇪Oldenburg, Germany
Klinikum Ernst von Bergmann gGmbH -Investigational Site Number : 2760039
🇩🇪Potsdam, Germany
Investigational Site Number : 2760040
🇩🇪Stolberg, Germany
Investigational Site Number : 2760031
🇩🇪Weilheim, Germany
Investigational Site Number : 2760019
🇩🇪Wuerzburg, Germany
Investigational Site Number : 3000005
🇬🇷Piraeus, Greece
Investigational Site Number : 3440001
🇭🇰Hong Kong, Hong Kong
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800009
🇮🇹Rome, Roma, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Investigational Site Number : 3800002
🇮🇹Rome, Roma, Italy
Investigational Site Number : 3800006
🇮🇹Bari, Italy
Istituto di Ematologia e Oncologia Medica - Investigational Site Number : 3800005
🇮🇹Bologna, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800007
🇮🇹Brescia, Italy
Investigational Site Number : 3800003
🇮🇹Milan, Italy
Azienda Ospedaliera Universitaria "Federico II"-Investigational Site Number : 3800001
🇮🇹Napoli, Italy
Investigational Site Number : 3800008
🇮🇹Novara, Italy
Investigational Site Number : 3800013
🇮🇹Pavia, Italy
Investigational Site Number : 3800004
🇮🇹Trento, Italy
Investigational Site Number : 3800010
🇮🇹Treviso, Italy
Investigational Site Number : 3920012
🇯🇵Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920009
🇯🇵Osaka-shi, Osaka, Japan
Investigational Site Number : 3920003
🇯🇵Sunto-gun, Shizuoka, Japan
Investigational Site Number : 3920004
🇯🇵Minato-ku, Tokyo, Japan
Investigational Site Number : 3920010
🇯🇵Fukuoka-shi, Japan
Investigational Site Number : 3920013
🇯🇵Minato-ku, Japan
Investigational Site Number : 3920005
🇯🇵Okayama-shi, Japan
Investigational Site Number : 3920014
🇯🇵Osakasayama-shi, Japan
Investigational Site Number : 3920008
🇯🇵Shibukawa-shi, Japan
Investigational Site Number : 3920011
🇯🇵Suwa-shi, Japan
Investigational Site Number : 3920001
🇯🇵Yamagata-shi, Japan
Investigational Site Number : 4140001
🇰🇼Kuwait, Kuwait
Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001
🇳🇱Dordrecht, Netherlands
Puerto Rico Medical Research Center, LLC Site Number : 8400001
🇵🇷Hato Rey, Puerto Rico
Auxilio Mutuo Cancer Center Site Number : 8400029
🇵🇷San Juan, Puerto Rico
Investigational Site Number : 6430006
🇷🇺Volgograd, Russian Federation
Investigational Site Number : 6820005
🇸🇦Jeddah, Saudi Arabia
Investigational Site Number : 6820004
🇸🇦Jeddah, Saudi Arabia
Investigational Site Number : 6820001
🇸🇦Khobar, Saudi Arabia
Investigational Site Number : 6820002
🇸🇦Riyadh, Saudi Arabia
Hospital Universitari Son Espases - Investigational Site Number : 7240003
🇪🇸Palma de Mallorca, Baleares, Spain
Complejo Asistencial Universitario de Leon Altos de Nava s/n. -Investigational Site Number : 7240005
🇪🇸Leon, León, Spain
Hospital Regional Universitario de Malaga Hospital Regional Universitario de Malaga - Investigational Site Number : 7240006
🇪🇸Malaga, Málaga, Spain
Hospital Universitario de Navarra - Investigational Site Number : 7240009
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario Virgen de la Nieves - Investigational Site Number : 7240010
🇪🇸Granada, Spain
Complejo Hospitalario Universitario de Pontevedra - Investigational Site Number : 7240011
🇪🇸Pontevedra, Spain
omplejo Hospitalario Universitario de Canarias - Investigational Site Number : 7240007
🇪🇸San Cristobal De La Laguna, Spain
Investigational Site Number : 7240004
🇪🇸Toledo, Spain
Kantonsspital Baden AG - Investigational Site Number : 5760003
🇨🇭Baden, Switzerland
Investigational Site Number : 5760001
🇨🇭Bern, Switzerland
Stadtspital Triemli - Investigational Site Number : 5760002
🇨🇭Zürich, Switzerland
Investigational Site Number : 1580002
🇨🇳Kaohsiung, Taiwan
Investigational Site Number : 1580001
🇨🇳Taipei, Taiwan
Investigational Site Number : 7840002
🇦🇪Abu Dhabi, United Arab Emirates
Investigational Site Number : 7840001
🇦🇪Abu dhabi, United Arab Emirates
Investigational Site Number : 8260002
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Investigational Site Number : 8260005
🇬🇧Sutton, Surrey, United Kingdom
Huddersfield Royal Infirmary - Investigational Site Number : 8260004
🇬🇧Huddersfield, United Kingdom
Freeman Hospital - Investigational Site Number : 8260003
🇬🇧Newcastle Upon Tyne, United Kingdom