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
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational [Patient Registry] |
Eligible Ages | 18 Years and Over |
Gender | All |
Age ≥18 years.
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04458831 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Sanofi |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Clinical Sciences & Operations |
Principal Investigator Affiliation | Sanofi |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Austria, Belgium, France, Germany, Italy, Japan, Netherlands, Puerto Rico, Spain, Switzerland, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Plasma Cell Myeloma |
Duration per participant is 2.5 years
: Cohort 1
Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria
Drug: - isatuximab SAR650984
Pharmaceutical form: solution for infusion Route of administration: intravenous
Drug: - Pomalidomide
Pharmaceutical form: oral
Drug: - Dexamethasone
Pharmaceutical form: oral
Drug: - Carfilzomib
Pharmaceutical form: solution for infusion
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Investigational Site Number 8400021
Little Rock, Arkansas, 72205
Status
Recruiting
Address
Investigational Site Number 8400009
San Francisco, California, 94143
Status
Recruiting
Address
Investigational Site Number 8400030
Fort Lauderdale, Florida, 33308
Status
Recruiting
Address
Investigational Site Number 8400007
Jacksonville, Florida, 32204
Status
Active, not recruiting
Address
Investigational Site Number 8400023
Lakeland, Florida, 33805
Status
Recruiting
Address
Investigational Site Number 8400025
Pembroke Pines, Florida, 33024
Status
Recruiting
Address
Investigational Site Number 8400026
Saint Petersburg, Florida, 33709
Status
Recruiting
Address
Investigational Site Number 8400019
Garden City, Kansas, 67846
Status
Active, not recruiting
Address
Investigational Site Number 8400010
Farmington Hills, Michigan, 48334
Status
Active, not recruiting
Address
Investigational Site Number 8400006
Bolivar, Missouri, 65613
Status
Recruiting
Address
Investigational Site Number 8400016
Kansas City, Missouri, 64114
Status
Recruiting
Address
Investigational Site Number 8400017
Freehold, New Jersey, 07728
Status
Recruiting
Address
Investigational Site Number 8400024
Howell, New Jersey, 07731
Status
Recruiting
Address
Investigational Site Number 8400018
Little Silver, New Jersey, 07739
Status
Recruiting
Address
Investigational Site Number 8400028
Winston-Salem, North Carolina, 27103
Status
Recruiting
Address
Investigational Site Number 8400015
Canton, Ohio, 44708
Status
Recruiting
Address
Investigational Site Number 8400012
Massillon, Ohio, 44646
Status
Recruiting
Address
Investigational Site Number 8400020
Charleston, South Carolina, 29414
Status
Recruiting
Address
Investigational Site Number 8400011
Greenville, South Carolina, 29615
Status
Active, not recruiting
Address
Investigational Site Number 8400002
Watertown, South Dakota, 57201
Status
Recruiting
Address
Investigational Site Number 8400013
Houston, Texas, 77030
Status
Active, not recruiting
Address
Investigational Site Number 8400004
The Woodlands, Texas, 77380
Status
Recruiting
Address
Investigational site number 0400002
Steyr, , 4400
Status
Active, not recruiting
Address
Investigational site number 0400003
Wien, , 1220
Status
Recruiting
Address
Investigational site number 5600001
Anderlecht, , 1070
Status
Recruiting
Address
Investigational site number 5600002
Sint-Niklaas, ,
Status
Recruiting
Address
Investigational site number 2500007
Argenteuil, , 95107
Status
Recruiting
Address
Investigational site number 2500006
Chambéry, , 73000
Status
Recruiting
Address
Investigational site number 2500012
Essey-lès-Nancy, , 54270
Status
Recruiting
Address
Investigational site number 2500013
Lille, , 59037
Status
Recruiting
Address
Investigational site number 2500004
Montpellier, , 34295
Status
Recruiting
Address
Investigational Site Number 2500009
Pessac, , 33604
Status
Recruiting
Address
Investigational site number 2500008
Poitiers, , 86000
Status
Recruiting
Address
Investigational site number 2500010
Reims, , 51100
Status
Recruiting
Address
Investigational site number 2500001
Rouen, , 76000
Status
Recruiting
Address
Investigational site number 2500005
Saint-Priest-en-Jarez, , 42270
Status
Recruiting
Address
Investigational site number 2500003
Toulouse, , 31059
Status
Recruiting
Address
Investigational site number 2500011
Vannes, , 56007
Status
Active, not recruiting
Address
Investigational Site Number 2760014
Aschaffenburg, , 63739
Status
Recruiting
Address
Investigational Site Number 2760016
Aschaffenburg, , 63739
Status
Active, not recruiting
Address
Investigational Site Number 2760025
Bad Liebenwerda, , 04924
Status
Recruiting
Address
Investigational Site Number 2760017
Baden-Baden, , 76532
Status
Recruiting
Address
Investigational Site Number 2760020
Bamberg, , 96052
Status
Recruiting
Address
Investigational Site Number 2760018
Bayreuth, , 95445
Status
Recruiting
Address
Investigational Site Number 2760003
Berlin, , 10117
Status
Recruiting
Address
Investigational Site Number 2760022
Berlin, , 10117
Status
Recruiting
Address
Investigational Site Number 2760041
Berlin, , 10437
Status
Recruiting
Address
Investigational Site Number 2760009
Berlin, , 10715
Status
Recruiting
Address
Investigational Site Number 2760007
Donauwörth, , 86609
Status
Recruiting
Address
Investigational site number 2760001
Dortmund, , 44263
Status
Recruiting
Address
Investigational Site Number 2760002
Dresden, , 01127
Status
Recruiting
Address
Investigational Site Number 2760035
Dresden, , 01307
Status
Recruiting
Address
Investigational Site Number 2760010
Frankfurt, , 60389
Status
Recruiting
Address
Investigational Site Number 2760037
Frankfurt, , 60596
Status
Recruiting
Address
Investigational Site Number 2760015
Goslar, , 38642
Status
Recruiting
Address
Investigational Site Number 2760012
Hanover, , 30449
Status
Recruiting
Address
Investigational Site Number 2760013
Herrsching Am Ammersee, , 82211
Status
Recruiting
Address
Investigational Site Number 2760034
Koeln, , 50677
Status
Recruiting
Address
Investigational Site Number 2760026
Kulmbach, , 95326
Status
Recruiting
Address
Investigational Site Number 2760008
Leipzig, , 04289
Status
Recruiting
Address
Investigational Site Number 2760011
Magdeburg, , 39104
Status
Recruiting
Address
Investigational Site Number 2760006
Muenchen, , 81241
Status
Recruiting
Address
Investigational Site Number 2760021
Oldenburg, , 26121
Status
Recruiting
Address
Investigational Site Number 2760036
Oldenburg, , 26133
Status
Recruiting
Address
Investigational Site Number 2760040
Stolberg, , 52222
Status
Recruiting
Address
Investigational Site Number 2760031
Weilheim, , 82362
Status
Recruiting
Address
Investigational Site Number 2760019
Würzburg, , 97080
Status
Recruiting
Address
Investigational Site Number 3800005
Bologna, , 40138
Status
Recruiting
Address
Investigational Site Number 3800007
Brescia, , 25123
Status
Recruiting
Address
Investigational Site Number 3800001
Napoli, , 80131
Status
Recruiting
Address
Investigational Site Number 3800010
Treviso, ,
Status
Recruiting
Address
Investigational Site Number 3920010
Fukuoka, , 815-8555
Status
Recruiting
Address
Investigational Site Number 3920002
Kamogawa, , 296-8602
Status
Recruiting
Address
Investigational Site Number 3920007
Kashiwa, , 277-8567
Status
Recruiting
Address
Investigational Site Number 3920004
Minato-Ku, , 105-8470
Status
Recruiting
Address
Investigational Site Number 3920005
Okayama, , 701-1192
Status
Recruiting
Address
Investigational Site Number 3920009
Osaka, , 543-8555
Status
Recruiting
Address
Investigational Site Number 3920012
Sapporo, , 003-0006
Status
Recruiting
Address
Investigational Site Number 3920008
Shibukawa, , 377-0280
Status
Recruiting
Address
Investigational Site Number 3920006
Shibuya, , 150-8935
Status
Recruiting
Address
Investigational Site Number 3920003
Sunto-gun, , 411-8777
Status
Recruiting
Address
Investigational Site Number 3920011
Suwa, , 392-8510
Status
Recruiting
Address
Investigational Site Number 3920001
Yamagata-shi, , 990-9585
Status
Recruiting
Address
Investigational Site Number 5820001
Dordrecht, , 3318AT
Status
Recruiting
Address
Investigational Site Number 8400001
Hato Rey, , 00917
Status
Recruiting
Address
Investigational Site Number 8400029
San juan, , 00918
Status
Recruiting
Address
Investigational Site Number 7240005
León, , 24071
Status
Recruiting
Address
Investigational Site Number 7240003
Palma De Mallorca, , 07120
Status
Recruiting
Address
Investigational Site Number 7240009
Pamplona, , 31008
Status
Recruiting
Address
Investigational Site Number 5760003
Baden, , 5404
Status
Recruiting
Address
Investigational Site Number 5760001
Bern, , 3010
Status
Recruiting
Address
Investigational Site Number 5760002
Zürich, , 8063
Status
Recruiting
Address
Investigational Site Number 8260004
Huddersfield, , HD3 3EA
Status
Recruiting
Address
Investigational Site Number 8260003
Newcastle Upon Tyne, , NE7 7DN
Status
Recruiting
Address
Investigational Site Number 8260005
Sutton, , SM2 5PT