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

Study Purpose

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

Recruitment Criteria

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
More Inclusion & Exclusion 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.

Trial Details

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 Argentina, Austria, Belgium, China, France, Germany, Hong Kong, Italy, Japan, Kuwait, Netherlands, Puerto Rico, Russian Federation, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plasma Cell Myeloma
Additional Details

Duration per participant is 2.5 years

Arms & Interventions

Arms

: Cohort 1

Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria

Interventions

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

Contact a Trial Team

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.

Little Rock, Arkansas

Status

Recruiting

Address

University of Arkansas Medical Sciences Site Number : 8400021

Little Rock, Arkansas, 72205-7199

Fullerton, California

Status

Recruiting

Address

St. Joseph Heritage Healthcare Site Number : 8400008

Fullerton, California, 92835

San Francisco, California

Status

Recruiting

Address

University of California San Francisco (PARENT) Site Number : 8400009

San Francisco, California, 94143

Fort Lauderdale, Florida

Status

Recruiting

Address

Holy Cross Hospital Site Number : 8400030

Fort Lauderdale, Florida, 33308

GenesisCare Site Number : 8400007, Jacksonville, Florida

Status

Recruiting

Address

GenesisCare Site Number : 8400007

Jacksonville, Florida, 32204

Lakeland, Florida

Status

Recruiting

Address

Watson Clinic Cancer and Research Center Site Number : 8400023

Lakeland, Florida, 33805

Pembroke Pines, Florida

Status

Recruiting

Address

Millennium Oncology Site Number : 8400025

Pembroke Pines, Florida, 33024

Saint Petersburg, Florida

Status

Recruiting

Address

Comprehensive Hematology Oncology Site Number : 8400026

Saint Petersburg, Florida, 33709

Garden City, Kansas

Status

Recruiting

Address

Central Care Cancer Center Site Number : 8400006

Garden City, Kansas, 67846

Garden City, Kansas

Status

Recruiting

Address

Central Care Cancer Center Site Number : 8400019

Garden City, Kansas, 67846

Lewiston, Maine

Status

Recruiting

Address

Central Maine Medical Center Site Number : 8400031

Lewiston, Maine, 04240

Watertown, Massachusetts

Status

Recruiting

Address

Prairie Lakes Health Care System, Inc Site Number : 8400002

Watertown, Massachusetts, 57201-1548

Farmington Hills, Michigan

Status

Recruiting

Address

Michigan Center of Medical Research Site Number : 8400010

Farmington Hills, Michigan, 48334

AMR Kansas City Site Number : 8400016, Kansas City, Missouri

Status

Recruiting

Address

AMR Kansas City Site Number : 8400016

Kansas City, Missouri, 64114

Freehold, New Jersey

Status

Recruiting

Address

Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017

Freehold, New Jersey, 07728

Howell, New Jersey

Status

Recruiting

Address

Regional Cancer Care Associates Site Number : 8400024

Howell, New Jersey, 07731

Little Silver, New Jersey

Status

Recruiting

Address

Regional Cancer Care Associates - Little Silver Division Site Number : 8400018

Little Silver, New Jersey, 07739

Winston-Salem, North Carolina

Status

Recruiting

Address

Novant Health Forsyth Medical Center Site Number : 8400028

Winston-Salem, North Carolina, 27103

Canton, Ohio

Status

Recruiting

Address

Hematology & Oncology Associates Site Number : 8400015

Canton, Ohio, 44708

Massillon, Ohio

Status

Recruiting

Address

Tri County Hematology & Oncology Associates, Inc Site Number : 8400012

Massillon, Ohio, 44646

Charleston, South Carolina

Status

Recruiting

Address

Charleston Hematology Oncology Associates, PA Site Number : 8400020

Charleston, South Carolina, 29414

Greenville, South Carolina

Status

Recruiting

Address

Prisma Health - Eastside Office Site Number : 8400011

Greenville, South Carolina, 29615

Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center Site Number : 8400013

Houston, Texas, 77030-4000

Renovatio Clinical Site Number : 8400004, The Woodlands, Texas

Status

Recruiting

Address

Renovatio Clinical Site Number : 8400004

The Woodlands, Texas, 77380

International Sites

Investigational Site Number : 0320001, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Status

Recruiting

Address

Investigational Site Number : 0320001

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1181ACH

Investigational Site Number : 0320002, Cordoba, Argentina

Status

Recruiting

Address

Investigational Site Number : 0320002

Cordoba, , 5016

Investigational Site Number : 0400002, Steyr, Austria

Status

Recruiting

Address

Investigational Site Number : 0400002

Steyr, , 4400

Investigational Site Number : 0400003, Wien, Austria

Status

Recruiting

Address

Investigational Site Number : 0400003

Wien, , 1220

Investigational Site Number : 0560001, Brussels, Belgium

Status

Recruiting

Address

Investigational Site Number : 0560001

Brussels, , 1000

Investigational Site Number : 0560002, Sint Niklaas, Belgium

Status

Recruiting

Address

Investigational Site Number : 0560002

Sint Niklaas, , 9100

Investigational Site Number : 1560001, Shenzhen, China

Status

Recruiting

Address

Investigational Site Number : 1560001

Shenzhen, , 518053

Investigational Site Number : 2500007, Argenteuil, France

Status

Recruiting

Address

Investigational Site Number : 2500007

Argenteuil, , 95107

Investigational Site Number : 2500006, Chambéry, France

Status

Recruiting

Address

Investigational Site Number : 2500006

Chambéry, , 73000

Investigational Site Number : 2500012, Essey les Nancy, France

Status

Recruiting

Address

Investigational Site Number : 2500012

Essey les Nancy, , 54270

Investigational Site Number : 2500015, Le Mans Cedex, France

Status

Recruiting

Address

Investigational Site Number : 2500015

Le Mans Cedex, , 72037

Investigational Site Number : 2500013, Lille, France

Status

Recruiting

Address

Investigational Site Number : 2500013

Lille, , 59800

Investigational Site Number : 2500004, Montpellier Cedex 5, France

Status

Recruiting

Address

Investigational Site Number : 2500004

Montpellier Cedex 5, , 34295

Investigational Site Number : 2500009, Pessac cedex, France

Status

Recruiting

Address

Investigational Site Number : 2500009

Pessac cedex, , 33604

Investigational Site Number : 2500008, Poitiers, France

Status

Recruiting

Address

Investigational Site Number : 2500008

Poitiers, , 86021

Investigational Site Number : 2500010, Reims, France

Status

Recruiting

Address

Investigational Site Number : 2500010

Reims, , 51092

Investigational Site Number : 2500001, Rouen, France

Status

Recruiting

Address

Investigational Site Number : 2500001

Rouen, , 76038

Investigational Site Number : 2500005, Saint Priest En Jarez, France

Status

Recruiting

Address

Investigational Site Number : 2500005

Saint Priest En Jarez, , 42270

Investigational Site Number : 2500016, Tarbes, France

Status

Recruiting

Address

Investigational Site Number : 2500016

Tarbes, , 65013

Investigational Site Number : 2500003, Toulouse, France

Status

Withdrawn

Address

Investigational Site Number : 2500003

Toulouse, , 31059

Investigational Site Number : 2500011, Vannes Cedex, France

Status

Recruiting

Address

Investigational Site Number : 2500011

Vannes Cedex, , 56017

Investigational Site Number : 2760014, Aschaffenburg, Germany

Status

Recruiting

Address

Investigational Site Number : 2760014

Aschaffenburg, , 63739

Investigational Site Number : 2760016, Aschaffenburg, Germany

Status

Recruiting

Address

Investigational Site Number : 2760016

Aschaffenburg, , 63739

Investigational Site Number : 2760025, Bad Liebenwerda, Germany

Status

Recruiting

Address

Investigational Site Number : 2760025

Bad Liebenwerda, , 04924

Investigational Site Number : 2760017, Baden-Baden, Germany

Status

Recruiting

Address

Investigational Site Number : 2760017

Baden-Baden, , 76532

Investigational Site Number : 2760020, Bamberg, Germany

Status

Recruiting

Address

Investigational Site Number : 2760020

Bamberg, , 96052

Investigational Site Number : 2760018, Bayreuth, Germany

Status

Recruiting

Address

Investigational Site Number : 2760018

Bayreuth, , 95445

Investigational Site Number : 2760003, Berlin, Germany

Status

Recruiting

Address

Investigational Site Number : 2760003

Berlin, , 10117

Investigational Site Number : 2760041, Berlin, Germany

Status

Recruiting

Address

Investigational Site Number : 2760041

Berlin, , 10437

Investigational Site Number : 2760009, Berlin, Germany

Status

Recruiting

Address

Investigational Site Number : 2760009

Berlin, , 10715

Investigational Site Number : 2760022, Berlin, Germany

Status

Recruiting

Address

Investigational Site Number : 2760022

Berlin, , 12200

Investigational Site Number : 2760007, Donauwoerth, Germany

Status

Recruiting

Address

Investigational Site Number : 2760007

Donauwoerth, , 86609

Investigational Site Number : 2760001, Dortmund, Germany

Status

Recruiting

Address

Investigational Site Number : 2760001

Dortmund, , 44263

Investigational Site Number : 2760002, Dresden, Germany

Status

Recruiting

Address

Investigational Site Number : 2760002

Dresden, , 01127

Investigational Site Number : 2760035, Dresden, Germany

Status

Recruiting

Address

Investigational Site Number : 2760035

Dresden, , 01307

Investigational Site Number : 2760010, Frankfurt am Main, Germany

Status

Recruiting

Address

Investigational Site Number : 2760010

Frankfurt am Main, , 60389

Investigational Site Number : 2760037, Frankfurt, Germany

Status

Recruiting

Address

Investigational Site Number : 2760037

Frankfurt, , 60596

Investigational Site Number : 2760015, Goslar, Germany

Status

Recruiting

Address

Investigational Site Number : 2760015

Goslar, , 38642

Investigational Site Number : 2760012, Hannover, Germany

Status

Recruiting

Address

Investigational Site Number : 2760012

Hannover, , 30449

Investigational Site Number : 2760013, Herrsching, Germany

Status

Recruiting

Address

Investigational Site Number : 2760013

Herrsching, , 82211

Investigational Site Number : 2760034, Koeln, Germany

Status

Recruiting

Address

Investigational Site Number : 2760034

Koeln, , 50677

Investigational Site Number : 2760026, Kulmbach, Germany

Status

Recruiting

Address

Investigational Site Number : 2760026

Kulmbach, , 95326

Investigational Site Number : 2760008, Leipzig, Germany

Status

Recruiting

Address

Investigational Site Number : 2760008

Leipzig, , 04289

Investigational Site Number : 2760011, Magdeburg, Germany

Status

Recruiting

Address

Investigational Site Number : 2760011

Magdeburg, , 39104

Investigational Site Number : 2760038, Marburg, Germany

Status

Recruiting

Address

Investigational Site Number : 2760038

Marburg, , 35037

Investigational Site Number : 2760006, Muenchen, Germany

Status

Recruiting

Address

Investigational Site Number : 2760006

Muenchen, , 81241

Investigational Site Number : 2760042, Mutlangen, Germany

Status

Recruiting

Address

Investigational Site Number : 2760042

Mutlangen, , 73557

Investigational Site Number : 2760044, Neubrandenburg, Germany

Status

Recruiting

Address

Investigational Site Number : 2760044

Neubrandenburg, , 17036

Investigational Site Number : 2760021, Oldenburg, Germany

Status

Recruiting

Address

Investigational Site Number : 2760021

Oldenburg, , 26121

Investigational Site Number : 2760036, Oldenburg, Germany

Status

Recruiting

Address

Investigational Site Number : 2760036

Oldenburg, , 26133

Investigational Site Number : 2760039, Potsdam, Germany

Status

Recruiting

Address

Investigational Site Number : 2760039

Potsdam, , 14467

Investigational Site Number : 2760040, Stolberg, Germany

Status

Recruiting

Address

Investigational Site Number : 2760040

Stolberg, , 52222

Investigational Site Number : 2760031, Weilheim, Germany

Status

Recruiting

Address

Investigational Site Number : 2760031

Weilheim, , 82362

Investigational Site Number : 2760019, Wuerzburg, Germany

Status

Recruiting

Address

Investigational Site Number : 2760019

Wuerzburg, , 97070

Investigational Site Number : 3440001, Hong Kong, Hong Kong

Status

Recruiting

Address

Investigational Site Number : 3440001

Hong Kong, ,

Investigational Site Number : 3800009, Rome, Roma, Italy

Status

Recruiting

Address

Investigational Site Number : 3800009

Rome, Roma, 00133

Investigational Site Number : 3800002, Rome, Roma, Italy

Status

Recruiting

Address

Investigational Site Number : 3800002

Rome, Roma, 00137

Investigational Site Number : 3800005, Bologna, Italy

Status

Recruiting

Address

Investigational Site Number : 3800005

Bologna, , 40138

Investigational Site Number : 3800007, Brescia, Italy

Status

Recruiting

Address

Investigational Site Number : 3800007

Brescia, , 25123

Investigational Site Number : 3800003, Milan, Italy

Status

Recruiting

Address

Investigational Site Number : 3800003

Milan, , 20132

Investigational Site Number : 3800001, Napoli, Italy

Status

Recruiting

Address

Investigational Site Number : 3800001

Napoli, , 80138

Investigational Site Number : 3800008, Novara, Italy

Status

Recruiting

Address

Investigational Site Number : 3800008

Novara, , 28100

Investigational Site Number : 3800010, Treviso, Italy

Status

Recruiting

Address

Investigational Site Number : 3800010

Treviso, , 31100

Investigational Site Number : 3920012, Sapporo-shi, Hokkaido, Japan

Status

Recruiting

Address

Investigational Site Number : 3920012

Sapporo-shi, Hokkaido, 003-0006

Investigational Site Number : 3920009, Osaka-shi, Osaka, Japan

Status

Recruiting

Address

Investigational Site Number : 3920009

Osaka-shi, Osaka, 543-8555

Investigational Site Number : 3920003, Sunto-gun, Shizuoka, Japan

Status

Recruiting

Address

Investigational Site Number : 3920003

Sunto-gun, Shizuoka, 411-8777

Investigational Site Number : 3920004, Minato-ku, Tokyo, Japan

Status

Recruiting

Address

Investigational Site Number : 3920004

Minato-ku, Tokyo, 105-8470

Investigational Site Number : 3920006, Shibuya-ku, Tokyo, Japan

Status

Withdrawn

Address

Investigational Site Number : 3920006

Shibuya-ku, Tokyo, 150-8935

Investigational Site Number : 3920010, Fukuoka-shi, Japan

Status

Recruiting

Address

Investigational Site Number : 3920010

Fukuoka-shi, , 815-8555

Investigational Site Number : 3920002, Kamogawa-shi, Japan

Status

Withdrawn

Address

Investigational Site Number : 3920002

Kamogawa-shi, , 296-8602

Investigational Site Number : 3920007, Kashiwa-shi, Japan

Status

Withdrawn

Address

Investigational Site Number : 3920007

Kashiwa-shi, , 277-8567

Investigational Site Number : 3920013, Minato-ku, Japan

Status

Recruiting

Address

Investigational Site Number : 3920013

Minato-ku, , 105-8471

Investigational Site Number : 3920005, Okayama-shi, Japan

Status

Recruiting

Address

Investigational Site Number : 3920005

Okayama-shi, , 701-1192

Investigational Site Number : 3920014, Osakasayama-shi, Japan

Status

Recruiting

Address

Investigational Site Number : 3920014

Osakasayama-shi, , 589-8511

Investigational Site Number : 3920008, Shibukawa-shi, Japan

Status

Recruiting

Address

Investigational Site Number : 3920008

Shibukawa-shi, , 377-0280

Investigational Site Number : 3920011, Suwa-shi, Japan

Status

Recruiting

Address

Investigational Site Number : 3920011

Suwa-shi, , 392-8510

Investigational Site Number : 3920001, Yamagata-shi, Japan

Status

Recruiting

Address

Investigational Site Number : 3920001

Yamagata-shi, , 990-9585

Investigational Site Number : 4140001, Kuwait, Kuwait

Status

Recruiting

Address

Investigational Site Number : 4140001

Kuwait, , 42262

Investigational Site Number : 5820001, Dordrecht, Netherlands

Status

Recruiting

Address

Investigational Site Number : 5820001

Dordrecht, , 3318 AT

Hato Rey, Puerto Rico

Status

Recruiting

Address

Puerto Rico Medical Research Center, LLC Site Number : 8400001

Hato Rey, , 00917

San Juan, Puerto Rico

Status

Recruiting

Address

Auxilio Mutuo Cancer Center Site Number : 8400029

San Juan, , 00917

Investigational Site Number : 6430006, Volgograd, Russian Federation

Status

Recruiting

Address

Investigational Site Number : 6430006

Volgograd, , 400138

Investigational Site Number : 6820004, Jeddah, Saudi Arabia

Status

Recruiting

Address

Investigational Site Number : 6820004

Jeddah, , 23431 6688

Investigational Site Number : 6820001, Khobar, Saudi Arabia

Status

Recruiting

Address

Investigational Site Number : 6820001

Khobar, , 34234

Investigational Site Number : 7240005, Leon, León, Spain

Status

Recruiting

Address

Investigational Site Number : 7240005

Leon, León, 24071

Investigational Site Number : 7240006, Malaga, Málaga, Spain

Status

Recruiting

Address

Investigational Site Number : 7240006

Malaga, Málaga, 29010

Investigational Site Number : 7240009, Pamplona, Navarra, Spain

Status

Recruiting

Address

Investigational Site Number : 7240009

Pamplona, Navarra, 31008

Investigational Site Number : 7240010, Granada, Spain

Status

Recruiting

Address

Investigational Site Number : 7240010

Granada, , 18012

Investigational Site Number : 7240003, Palma de Mallorca, Spain

Status

Recruiting

Address

Investigational Site Number : 7240003

Palma de Mallorca, , 07120

Investigational Site Number : 7240011, Pontevedra, Spain

Status

Recruiting

Address

Investigational Site Number : 7240011

Pontevedra, , 36001

Investigational Site Number : 7240007, San Cristobal De La Laguna, Spain

Status

Recruiting

Address

Investigational Site Number : 7240007

San Cristobal De La Laguna, , 38320

Investigational Site Number : 7240004, Toledo, Spain

Status

Recruiting

Address

Investigational Site Number : 7240004

Toledo, , 45003

Investigational Site Number : 5760003, Baden, Switzerland

Status

Recruiting

Address

Investigational Site Number : 5760003

Baden, , 5404

Investigational Site Number : 5760001, Bern, Switzerland

Status

Recruiting

Address

Investigational Site Number : 5760001

Bern, , 3010

Investigational Site Number : 5760002, Zürich, Switzerland

Status

Recruiting

Address

Investigational Site Number : 5760002

Zürich, , 8063

Investigational Site Number : 7840002, Abu Dhabi, United Arab Emirates

Status

Recruiting

Address

Investigational Site Number : 7840002

Abu Dhabi, , 11001

Investigational Site Number : 7840001, Abu dhabi, United Arab Emirates

Status

Recruiting

Address

Investigational Site Number : 7840001

Abu dhabi, , 7400

Investigational Site Number : 8260002, Nottingham, Nottinghamshire, United Kingdom

Status

Recruiting

Address

Investigational Site Number : 8260002

Nottingham, Nottinghamshire, NG5 1PB

Investigational Site Number : 8260005, Sutton, Surrey, United Kingdom

Status

Recruiting

Address

Investigational Site Number : 8260005

Sutton, Surrey, SM2 5PT

Investigational Site Number : 8260004, Huddersfield, United Kingdom

Status

Recruiting

Address

Investigational Site Number : 8260004

Huddersfield, , HD3 3EA

Investigational Site Number : 8260003, Newcastle Upon Tyne, United Kingdom

Status

Recruiting

Address

Investigational Site Number : 8260003

Newcastle Upon Tyne, , NE7 7DN