Multiple Myeloma Clinical Trial

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

Summary

Primary Objective:

To assess the effectiveness, in terms of overall response rate (ORR) of treatment-a-promising-new-option-for-relapsed-multiple-myeloma/" >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

View Full Description

Full Description

Duration per participant is 2.5 years

View Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

1200

Study ID:

NCT04458831

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 121 Locations for this study

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University of Arkansas Medical Sciences Site Number : 8400021
Little Rock Arkansas, 72205, United States
St. Joseph Heritage Healthcare Site Number : 8400008
Fullerton California, 92835, United States
University of California San Francisco (PARENT) Site Number : 8400009
San Francisco California, 94143, United States
Holy Cross Hospital Site Number : 8400030
Fort Lauderdale Florida, 33308, United States
GenesisCare Site Number : 8400007
Jacksonville Florida, 32204, United States
Watson Clinic Cancer and Research Center Site Number : 8400023
Lakeland Florida, 33805, United States
Millennium Oncology Site Number : 8400025
Pembroke Pines Florida, 33024, United States
Comprehensive Hematology Oncology Site Number : 8400026
Saint Petersburg Florida, 33709, United States
Central Care Cancer Center Site Number : 8400006
Garden City Kansas, 67846, United States
Central Care Cancer Center Site Number : 8400019
Garden City Kansas, 67846, United States
Central Maine Medical Center Site Number : 8400031
Lewiston Maine, 04240, United States
Michigan Center of Medical Research Site Number : 8400010
Farmington Hills Michigan, 48334, United States
AMR Kansas City Site Number : 8400016
Kansas City Missouri, 64114, United States
Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017
Freehold New Jersey, 07728, United States
Regional Cancer Care Associates Site Number : 8400024
Howell New Jersey, 07731, United States
Regional Cancer Care Associates - Little Silver Division Site Number : 8400018
Little Silver New Jersey, 07739, United States
Novant Health Forsyth Medical Center Site Number : 8400028
Winston-Salem North Carolina, 27103, United States
Hematology & Oncology Associates Site Number : 8400015
Canton Ohio, 44708, United States
Tri County Hematology & Oncology Associates, Inc Site Number : 8400012
Massillon Ohio, 44646, United States
Charleston Hematology Oncology Associates, PA Site Number : 8400020
Charleston South Carolina, 29414, United States
Prisma Health - Eastside Office Site Number : 8400011
Greenville South Carolina, 29615, United States
Prairie Lakes Health Care System, Inc Site Number : 8400002
Watertown South Dakota, 57201, United States
MD Anderson Cancer Center Site Number : 8400013
Houston Texas, 77030, United States
Renovatio Clinical Site Number : 8400004
The Woodlands Texas, 77380, United States
Investigational Site Number : 0320001
Ciudad Autonoma de Buenos Aires Buenos Aires, C1181, Argentina
Investigational Site Number : 0320004
Buenos Aires , C1118, Argentina
Investigational Site Number : 0320002
Cordoba , X5016, Argentina
LKH Steyr - Investigational Site Number : 0400002
Steyr , 4400, Austria More Info
Hanns HAUSER
Contact
+43505546624210
Hanns HAUSER
Principal Investigator
Investigational Site Number : 0400003
Wien , 1220, Austria
Institut Jules Bordet - Investigational Site Number : 0560001
Anderlecht , 1070, Belgium More Info
Meuleman
Contact
+3225413728
Nathalie Meuleman
Principal Investigator
AZ Nikolaas - Investigational Site Number : 0560002
Sint Niklaas , 9100, Belgium More Info
Isabelle VANDE BROEK
Contact
+3237602985
Isabelle VANDE BROEK
Principal Investigator
Investigational Site Number : 1560002
Guangzhou , 51012, China
Investigational Site Number : 1560001
Shenzhen , 51805, China
Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007
Argenteuil , 95107, France More Info
Emanuelle LE RAY
Contact
+33134231566
Emanuelle LE RAY
Principal Investigator
Investigational Site Number : 2500017
Cahors , 46000, France
Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006
Chambéry , 73000, France More Info
Pierre FAURI
Contact
+33479965105
Pierre FAURI
Principal Investigator
Investigational Site Number : 2500012
Essey les Nancy , 54270, France
Centre Hospitalier Le Mans - Investigational Site Number : 2500015
Le Mans Cedex , 72037, France More Info
Laribi Kamel
Contact
+33255463467
Laribi Kamel
Principal Investigator
Investigational Site Number : 2500013
Lille , 59800, France
Investigational Site Number : 2500004
Montpellier Cedex 5 , 34295, France
Investigational Site Number : 2500009
Pessac cedex , 33604, France
CHU Poitiers - Hôpital la Milétrie - Investigational Site Number : 2500008
Poitiers , 86021, France More Info
Xavier LEULEU
Contact
+33549444201
Xavier LEULEU
Principal Investigator
CHU Reims - Hôpital Robert Debré - Investigational Site Number : 2500010
Reims , 51092, France More Info
Sophie GODET
Contact
+33326783644
Sophie GODET
Principal Investigator
Investigational Site Number : 2500001
Rouen , 76038, France
Investigational Site Number : 2500005
Saint Priest En Jarez , 42270, France
Investigational Site Number : 2500014
Saint Quentin cedex , 02321, France
Investigational Site Number : 2500016
Tarbes , 65013, France
Investigational Site Number : 2500003
Toulouse , 31059, France
Investigational Site Number : 2500011
Vannes Cedex , 56017, France
Investigational Site Number : 2760014
Aschaffenburg , 63739, Germany
Investigational Site Number : 2760016
Aschaffenburg , 63739, Germany
Investigational Site Number : 2760025
Bad Liebenwerda , 04924, Germany
Investigational Site Number : 2760017
Baden-Baden , 76532, Germany
Investigational Site Number : 2760020
Bamberg , 96052, Germany
Investigational Site Number : 2760018
Bayreuth , 95445, Germany
Investigational Site Number : 2760003
Berlin , 10117, Germany
Investigational Site Number : 2760041
Berlin , 10437, Germany
Praxis am Volkspark - Investigational Site Number : 2760009
Berlin , 10715, Germany More Info
Carsten-Oliver SCHULZ
Contact
+493084723535
Carsten-Oliver SCHULZ
Principal Investigator
Investigational Site Number : 2760022
Berlin , 12200, Germany
Investigational Site Number : 2760007
Donauwoerth , 86609, Germany
GEFOS Gesellschaft f. onkologische Studien -Investigational Site Number : 2760001
Dortmund , 44263, Germany More Info
Clemens SHULTE
Contact
+492312069011
Investigational Site Number : 2760002
Dresden , 01127, Germany
Investigational Site Number : 2760035
Dresden , 01307, Germany
Investigational Site Number : 2760010
Frankfurt am Main , 60389, Germany
Investigational Site Number : 2760037
Frankfurt , 60596, Germany
Investigational Site Number : 2760015
Goslar , 38642, Germany
Investigational Site Number : 2760012
Hannover , 30449, Germany
Investigational Site Number : 2760013
Herrsching , 82211, Germany
MV Zentrum für Onkologie und Hämatologie - Investigational Site Number : 2760034
Koeln , 50677, Germany More Info
Tilman Steinmetz
Contact
+4922109318220
Tilman Steinmetz
Principal Investigator
Investigational Site Number : 2760026
Kulmbach , 95326, Germany
Investigational Site Number : 2760008
Leipzig , 04289, Germany
Investigational Site Number : 2760011
Magdeburg , 39104, Germany
Investigational Site Number : 2760038
Marburg , 35037, Germany
Investigational Site Number : 2760006
Muenchen , 81241, Germany
Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042
Mutlangen , 73557, Germany More Info
Holger Hebart
Contact
Holger Hebart
Contact
+4971717011302
Dietrich-Bonhoeffer-Klinikum - Investigational Site Number : 2760044
Neubrandenburg , 17036, Germany More Info
Hemmati
Contact
+493957753303
Philipp Hemmati
Principal Investigator
Investigational Site Number : 2760021
Oldenburg , 26121, Germany
Investigational Site Number : 2760036
Oldenburg , 26133, Germany
Klinikum Ernst von Bergmann gGmbH -Investigational Site Number : 2760039
Potsdam , 14467, Germany More Info
Frank Breywisch
Contact
+4933124136016
Frank Breywisch
Principal Investigator
Investigational Site Number : 2760040
Stolberg , 52222, Germany
Investigational Site Number : 2760031
Weilheim , 82362, Germany
Investigational Site Number : 2760019
Wuerzburg , 97070, Germany
Investigational Site Number : 3440001
Hong Kong , , Hong Kong
Investigational Site Number : 3800009
Rome Roma, 00133, Italy
Investigational Site Number : 3800002
Rome Roma, 00137, Italy
Istituto di Ematologia e Oncologia Medica - Investigational Site Number : 3800005
Bologna , 40138, Italy More Info
Michele CAVO
Contact
+390512143810
Michele CAVO
Principal Investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800007
Brescia , 25123, Italy More Info
Angelo Belotti
Contact
+39303996520
Angelo Belotti
Principal Investigator
Investigational Site Number : 3800003
Milan , 20132, Italy
Investigational Site Number : 3800001
Napoli , 80138, Italy
Investigational Site Number : 3800008
Novara , 28100, Italy
Investigational Site Number : 3800010
Treviso , 31100, Italy
Investigational Site Number : 3920012
Sapporo-shi Hokkaido, 003-0, Japan
Investigational Site Number : 3920009
Osaka-shi Osaka, 543-8, Japan
Investigational Site Number : 3920003
Sunto-gun Shizuoka, 411-8, Japan
Investigational Site Number : 3920004
Minato-ku Tokyo, 105-8, Japan
Investigational Site Number : 3920006
Shibuya-ku Tokyo, 150-8, Japan
Investigational Site Number : 3920010
Fukuoka-shi , 815-8, Japan
Investigational Site Number : 3920002
Kamogawa-shi , 296-8, Japan
Investigational Site Number : 3920007
Kashiwa-shi , 277-8, Japan
Investigational Site Number : 3920013
Minato-ku , 105-8, Japan
Investigational Site Number : 3920005
Okayama-shi , 701-1, Japan
Investigational Site Number : 3920014
Osakasayama-shi , 589-8, Japan
Investigational Site Number : 3920008
Shibukawa-shi , 377-0, Japan
Investigational Site Number : 3920011
Suwa-shi , 392-8, Japan
Investigational Site Number : 3920001
Yamagata-shi , 990-9, Japan
Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001
Dordrecht , 3318 , Netherlands More Info
Mark-David LEVIN
Contact
+31786523787
Mark-David LEVIN
Principal Investigator
Puerto Rico Medical Research Center, LLC Site Number : 8400001
Hato Rey , 00917, Puerto Rico
Auxilio Mutuo Cancer Center Site Number : 8400029
San Juan , 00917, Puerto Rico
Complejo Asistencial Universitario de Leon Altos de Nava s/n. -Investigational Site Number : 7240005
Leon León, 24071, Spain More Info
Fernando Escalante Barrigon
Contact
Fernando Escalante Barrigon
Principal Investigator
Hospital Regional Universitario de Malaga Hospital Regional Universitario de Malaga - Investigational Site Number : 7240006
Malaga Málaga, 29010, Spain More Info
Maria Magdalena Alcala Pena
Contact
+34951290000
Maria Magdalena Alcala Pena
Principal Investigator
Investigational Site Number : 7240009
Pamplona Navarra, 31008, Spain
Hospital Universitario Virgen de la Nieves - Investigational Site Number : 7240010
Granada , 18012, Spain More Info
Maria Esther Clavero Sanchez
Contact
+34958020000
Maria Esther Clavero Sanchez
Principal Investigator
Hospital Universitari Son Espases - Investigational Site Number : 7240003
Palma de Mallorca , 07120, Spain More Info
Antonia Sampol Mayol
Contact
+34871206268
Antonia Sampol Mayol
Principal Investigator
Complejo Hospitalario Universitario de Pontevedra - Investigational Site Number : 7240011
Pontevedra , 36001, Spain More Info
Ana Maria Dios Loureiro
Contact
+34986800399
Ana Maria Dios Loureiro
Principal Investigator
omplejo Hospitalario Universitario de Canarias - Investigational Site Number : 7240007
San Cristobal De La Laguna , 38320, Spain More Info
Sunil Lakhwani
Contact
+34922678033
Sunil Lakhwani
Principal Investigator
Investigational Site Number : 7240004
Toledo , 45003, Spain
Investigational Site Number : 5760003
Baden , 5404, Switzerland
Investigational Site Number : 5760001
Bern , 3010, Switzerland
Stadtspital Triemli - Investigational Site Number : 5760002
Zürich , 8063, Switzerland More Info
Mathias SCHMID
Contact
+41444163501
Mathias SCHMID
Principal Investigator
Investigational Site Number : 1580002
Kaohsiung , 83340, Taiwan
Investigational Site Number : 7840002
Abu Dhabi , 11001, United Arab Emirates
Investigational Site Number : 7840001
Abu dhabi , 7400, United Arab Emirates
Investigational Site Number : 8260002
Nottingham Nottinghamshire, NG5 1, United Kingdom
Investigational Site Number : 8260005
Sutton Surrey, SM2 5, United Kingdom
Investigational Site Number : 8260004
Huddersfield , HD3 3, United Kingdom
Freeman Hospital - Investigational Site Number : 8260003
Newcastle Upon Tyne , NE7 7, United Kingdom More Info
Jennifer Young
Contact
+441912336161
Jennifer Young
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

1200

Study ID:

NCT04458831

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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