Clinical trial NCT04458831: A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Official title: A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Plasma Cell Myeloma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The source population for this study will be patients with a diagnosis of RRMM recruited from participating sites in Asia, Europe, Latin America, and North America. The study will aim to enroll up to approximately 1200 adult patients with a recorded diagnosis of RRMM from up to 150 sites. A subset of patients from sites, limited to the US only, will be recruited (up to 100 patients out of 1200), for enrichment by leveraging existing electronic medical record (EMR) technologies coupled with the electronic case report forms (eCRFs).

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

Eligibility criteria: Age ≥18 years

* 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 up to three months before 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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 12 months
measure: Progression free survival (PFS)
timeFrame: up to 18 months
measure: Progression free survival rate (PFSR)
timeFrame: up to 18 months
measure: Duration of response (DoR)
timeFrame: 12 months
measure: Time to response (TTR)
timeFrame: 12 months
measure: Time to first subsequent anti-myeloma therapy
timeFrame: 30 months
measure: Rate of very good partial response or better
timeFrame: up to 12 months
measure: Rate of complete response (CR) or better
timeFrame: up to 12 months
measure: Number of Participants with Adverse events
timeFrame: 1 month after end of treatment
measure: 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)
timeFrame: through end of treatment (up to approximately 2 years)
measure: Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20)
timeFrame: through end of treatment (up to approximately 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas Medical Sciences Site Number : 8400021
state: Arkansas
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare Site Number : 8400008
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (PARENT) Site Number : 8400009
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Site Number : 8400030
state: Florida
city: Jacksonville
country: United States
facility: GenesisCare Site Number : 8400007
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Cancer and Research Center Site Number : 8400023
state: Florida
city: Pembroke Pines
country: United States
facility: Millennium Oncology Site Number : 8400025
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive Hematology Oncology Site Number : 8400026
state: Florida
city: Garden City
country: United States
facility: Central Care Cancer Center Site Number : 8400019
state: Kansas
city: Lewiston
country: United States
facility: Central Maine Medical Center Site Number : 8400031
state: Maine
city: Farmington Hills
country: United States
facility: Michigan Center of Medical Research Site Number : 8400010
state: Michigan
city: Garden City
country: United States
facility: Central Care Cancer Center Site Number : 8400006
state: Missouri
city: Kansas City
country: United States
facility: AMR Kansas City Site Number : 8400016
state: Missouri
city: Freehold
country: United States
facility: Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017
state: New Jersey
city: Howell
country: United States
facility: Regional Cancer Care Associates Site Number : 8400024
state: New Jersey
city: Little Silver
country: United States
facility: Regional Cancer Care Associates - Little Silver Division Site Number : 8400018
state: New Jersey
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center Site Number : 8400028
state: North Carolina
city: Canton
country: United States
facility: Hematology & Oncology Associates Site Number : 8400015
state: Ohio
city: Massillon
country: United States
facility: Tri County Hematology & Oncology Associates, Inc Site Number : 8400012
state: Ohio
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, PA Site Number : 8400020
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health - Eastside Office Site Number : 8400011
state: South Carolina
city: Watertown
country: United States
facility: Prairie Lakes Health Care System, Inc Site Number : 8400002
state: South Dakota
city: Houston
country: United States
facility: MD Anderson Cancer Center Site Number : 8400013
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical Site Number : 8400004
state: Texas
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
state: Buenos Aires
city: Pilar
country: Argentina
facility: Investigational Site Number : 0320006
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Cordoba
country: Argentina
facility: Investigational Site Number : 0320005
city: Cordoba
country: Argentina
facility: Investigational Site Number : 0320002
city: Steyr
country: Austria
facility: LKH Steyr - Investigational Site Number : 0400002
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet - Investigational Site Number : 0560001
city: Sint Niklaas
country: Belgium
facility: AZ Nikolaas - Investigational Site Number : 0560002
city: Guangzhou
country: China
facility: Investigational Site Number : 1560002
city: Shenzhen
country: China
facility: Investigational Site Number : 1560001
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007
city: Cahors
country: France
facility: Investigational Site Number : 2500017
city: Chambéry
country: France
facility: Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006
city: Essey les Nancy
country: France
facility: Clinique Louis Pasteur, Maison Médicale - Investigational Site Number : 2500012
city: Le Mans Cedex
country: France
facility: Centre Hospitalier Le Mans - Investigational Site Number : 2500015
city: Lille
country: France
facility: Investigational Site Number : 2500013
city: Montpellier Cedex 5
country: France
facility: Investigational Site Number : 2500004
city: Pessac cedex
country: France
facility: Investigational Site Number : 2500009
city: Poitiers
country: France
facility: CHU Poitiers - Hôpital la Milétrie - Investigational Site Number : 2500008
city: Reims
country: France
facility: CHU Reims - Hôpital Robert Debré - Investigational Site Number : 2500010
city: Rouen
country: France
facility: Investigational Site Number : 2500001
city: Saint Priest En Jarez
country: France
facility: Investigational Site Number : 2500005
city: Saint Quentin cedex
country: France
facility: Investigational Site Number : 2500014
city: Tarbes
country: France
facility: Investigational Site Number : 2500016
city: Vannes Cedex
country: France
facility: Investigational Site Number : 2500011
city: Aschaffenburg
country: Germany
facility: Investigational Site Number : 2760016
city: Bamberg
country: Germany
facility: Investigational Site Number : 2760020
city: Bayreuth
country: Germany
facility: Investigational Site Number : 2760018
city: Berlin
country: Germany
facility: Investigational Site Number : 2760003
city: Berlin
country: Germany
facility: Investigational Site Number : 2760041
city: Berlin
country: Germany
facility: Praxis am Volkspark - Investigational Site Number : 2760009
city: Berlin
country: Germany
facility: Investigational Site Number : 2760022
city: Donauwoerth
country: Germany
facility: Investigational Site Number : 2760007
city: Dortmund
country: Germany
facility: GEFOS Gesellschaft f. onkologische Studien -Investigational Site Number : 2760001
city: Dresden
country: Germany
facility: Investigational Site Number : 2760002
city: Dresden
country: Germany
facility: Investigational Site Number : 2760035
city: Frankfurt am Main
country: Germany
facility: Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus - Investigational Site Number : 2760010
city: Frankfurt
country: Germany
facility: Investigational Site Number : 2760037
city: Hannover
country: Germany
facility: Investigational Site Number : 2760012
city: Herrsching
country: Germany
facility: Investigational Site Number : 2760013
city: Koeln
country: Germany
facility: MV Zentrum für Onkologie und Hämatologie - Investigational Site Number : 2760034
city: Kulmbach
country: Germany
facility: Klinikum Kulmbach mit Fachklinik Stadtsteinach - Investigational Site Number : 2760026
city: Leipzig
country: Germany
facility: Investigational Site Number : 2760008
city: Marburg
country: Germany
facility: Philipps-Universitat Marburg, Klinic fur Innere Medizin -Investigational Site Number : 2760038
city: Muenchen
country: Germany
facility: Investigational Site Number : 2760006
city: Mutlangen
country: Germany
facility: Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042
city: Neubrandenburg
country: Germany
facility: Dietrich-Bonhoeffer-Klinikum - Investigational Site Number : 2760044
city: Oldenburg
country: Germany
facility: Investigational Site Number : 2760021
city: Oldenburg
country: Germany
facility: Investigational Site Number : 2760036
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann gGmbH -Investigational Site Number : 2760039
city: Stolberg
country: Germany
facility: Investigational Site Number : 2760040
city: Weilheim
country: Germany
facility: Investigational Site Number : 2760031
city: Wuerzburg
country: Germany
facility: Investigational Site Number : 2760019
city: Piraeus
country: Greece
facility: Investigational Site Number : 3000005
city: Hong Kong
country: Hong Kong
facility: Investigational Site Number : 3440001
city: Rome
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800009
state: Roma
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Investigational Site Number : 3800002
state: Roma
city: Bari
country: Italy
facility: Investigational Site Number : 3800006
city: Bologna
country: Italy
facility: Istituto di Ematologia e Oncologia Medica - Investigational Site Number : 3800005
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800007
city: Milan
country: Italy
facility: Investigational Site Number : 3800003
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"-Investigational Site Number : 3800001
city: Novara
country: Italy
facility: Investigational Site Number : 3800008
city: Pavia
country: Italy
facility: Investigational Site Number : 3800013
city: Trento
country: Italy
facility: Investigational Site Number : 3800004
city: Treviso
country: Italy
facility: Investigational Site Number : 3800010
city: Sapporo-shi
country: Japan
facility: Investigational Site Number : 3920012
state: Hokkaido
city: Osaka-shi
country: Japan
facility: Investigational Site Number : 3920009
state: Osaka
city: Sunto-gun
country: Japan
facility: Investigational Site Number : 3920003
state: Shizuoka
city: Minato-ku
country: Japan
facility: Investigational Site Number : 3920004
state: Tokyo
city: Fukuoka-shi
country: Japan
facility: Investigational Site Number : 3920010
city: Minato-ku
country: Japan
facility: Investigational Site Number : 3920013
city: Okayama-shi
country: Japan
facility: Investigational Site Number : 3920005
city: Osakasayama-shi
country: Japan
facility: Investigational Site Number : 3920014
city: Shibukawa-shi
country: Japan
facility: Investigational Site Number : 3920008
city: Suwa-shi
country: Japan
facility: Investigational Site Number : 3920011
city: Yamagata-shi
country: Japan
facility: Investigational Site Number : 3920001
city: Kuwait
country: Kuwait
facility: Investigational Site Number : 4140001
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001
city: Hato Rey
country: Puerto Rico
facility: Puerto Rico Medical Research Center, LLC Site Number : 8400001
city: San Juan
country: Puerto Rico
facility: Auxilio Mutuo Cancer Center Site Number : 8400029
city: Volgograd
country: Russian Federation
facility: Investigational Site Number : 6430006
city: Jeddah
country: Saudi Arabia
facility: Investigational Site Number : 6820005
city: Jeddah
country: Saudi Arabia
facility: Investigational Site Number : 6820004
city: Khobar
country: Saudi Arabia
facility: Investigational Site Number : 6820001
city: Riyadh
country: Saudi Arabia
facility: Investigational Site Number : 6820002
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases - Investigational Site Number : 7240003
state: Baleares
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon Altos de Nava s/n. -Investigational Site Number : 7240005
state: León
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga Hospital Regional Universitario de Malaga - Investigational Site Number : 7240006
state: Málaga
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra - Investigational Site Number : 7240009
state: Navarra
city: Granada
country: Spain
facility: Hospital Universitario Virgen de la Nieves - Investigational Site Number : 7240010
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Pontevedra - Investigational Site Number : 7240011
city: San Cristobal De La Laguna
country: Spain
facility: omplejo Hospitalario Universitario de Canarias - Investigational Site Number : 7240007
city: Toledo
country: Spain
facility: Investigational Site Number : 7240004
city: Baden
country: Switzerland
facility: Kantonsspital Baden AG - Investigational Site Number : 5760003
city: Bern
country: Switzerland
facility: Investigational Site Number : 5760001
city: Zürich
country: Switzerland
facility: Stadtspital Triemli - Investigational Site Number : 5760002
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number : 1580002
city: Taipei
country: Taiwan
facility: Investigational Site Number : 1580001
city: Abu Dhabi
country: United Arab Emirates
facility: Investigational Site Number : 7840002
city: Abu dhabi
country: United Arab Emirates
facility: Investigational Site Number : 7840001
city: Nottingham
country: United Kingdom
facility: Investigational Site Number : 8260002
state: Nottinghamshire
city: Sutton
country: United Kingdom
facility: Investigational Site Number : 8260005
state: Surrey
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary - Investigational Site Number : 8260004
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital - Investigational Site Number : 8260003
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: