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

NCT04458831 | Active Not Recruiting

• 1 other identifier: OBS16577
• Study Type: observational
• Target: 583
• Locations: 21 countries
• Sites: 129

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

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (11)

• Overall response rate (ORR)

  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

  12 months

• Progression free survival (PFS)

  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.

  Up to 30 months

• Progression free survival rate (PFSR)

  The proportion of patients who do not progress and are alive at a specific time intervals

  up to 18 months

• Duration of response (DoR)

  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.

  Up to 30 months

• Time to response (TTR)

  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

  Up to 30 months

• Time to first subsequent anti-myeloma therapy

  Time from the initiation of isatuximab until the start of subsequent therapy or death.

  Up to 30 months

• Rate of very good partial response or better

  Comprising VGPR, CR, and sCR within 12 months

  12 months

• Rate of complete response (CR) or better

  Comprising CR and sCR responses within 12 months

  12 months

• Number of Participants with Adverse events

  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: infusion associated reactions (IARs), pregnancy in a patient (or partner of a patient), symptomatic overdose, occurrence of a second primary 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

  Up to 1 month after the end of treatment

• 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)

  EORTC QLQ-MY20 standardized scores: 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.

  through end of treatment (up to approximately 2 years)

• Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20)

  EORTC QLQ-C30 standardized scores: 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).

  through end of treatment (up to approximately 2 years)

Study Arms (1)

Cohort 1

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

Drug: isatuximab SAR650984; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Carfilzomib

Interventions

isatuximab SAR650984 DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Also known as: Sarclisa

Cohort 1

Pomalidomide DRUG

Pharmaceutical form: oral

Also known as: Pomalyst

Cohort 1

Dexamethasone DRUG

Pharmaceutical form: oral

Cohort 1

Carfilzomib DRUG

Pharmaceutical form: solution for infusion

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 640 adult patients with a recorded diagnosis of RRMM from up to 150 sites. A subset of patients from sites, limited to the US and UK only, will be recruited (up to 100 patients out of 640), for enrichment by leveraging existing electronic medical record (EMR) technologies coupled with the electronic case report forms (eCRFs).

You may not qualify if:

• 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. Further eligibility criteria might apply.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (129)

University of Arkansas Medical Sciences Site Number : 8400021

Little Rock, Arkansas, 72205-7199, United States

Location

St. Joseph Heritage Healthcare Site Number : 8400008

Fullerton, California, 92835, United States

Location

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

San Francisco, California, 94143, United States

Location

Holy Cross Hospital Site Number : 8400030

Fort Lauderdale, Florida, 33308, United States

Location

GenesisCare Site Number : 8400007

Jacksonville, Florida, 32204, United States

Location

Watson Clinic Cancer and Research Center Site Number : 8400023

Lakeland, Florida, 33805, United States

Location

Millennium Oncology Site Number : 8400025

Pembroke Pines, Florida, 33024, United States

Location

Comprehensive Hematology Oncology Site Number : 8400026

St. Petersburg, Florida, 33709, United States

Location

Central Care Cancer Center Site Number : 8400019

Garden City, Kansas, 67846, United States

Location

Central Maine Medical Center Site Number : 8400031

Lewiston, Maine, 04240, United States

Location

Michigan Center of Medical Research Site Number : 8400010

Farmington Hills, Michigan, 48334, United States

Location

Central Care Cancer Center Site Number : 8400006

Garden City, Missouri, 67846, United States

Location

AMR Kansas City Site Number : 8400016

Kansas City, Missouri, 64114, United States

Location

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

Freehold, New Jersey, 07728, United States

Location

Regional Cancer Care Associates Site Number : 8400024

Howell Township, New Jersey, 07731, United States

Location

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

Little Silver, New Jersey, 07739, United States

Location

Novant Health Forsyth Medical Center Site Number : 8400028

Winston-Salem, North Carolina, 27103, United States

Location

Hematology & Oncology Associates Site Number : 8400015

Canton, Ohio, 44708, United States

Location

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

Massillon, Ohio, 44646, United States

Location

Charleston Hematology Oncology Associates, PA Site Number : 8400020

Charleston, South Carolina, 29414, United States

Location

Prisma Health - Eastside Office Site Number : 8400011

Greenville, South Carolina, 29615, United States

Location

Prairie Lakes Health Care System, Inc Site Number : 8400002

Watertown, South Dakota, 57201-1548, United States

Location

MD Anderson Cancer Center Site Number : 8400013

Houston, Texas, 77030-4000, United States

Location

Renovatio Clinical Site Number : 8400004

The Woodlands, Texas, 77380, United States

Location

Investigational Site Number : 0320001

Ciudad Autonoma Buenos Aires, Buenos Aires, 1199, Argentina

Location

Investigational Site Number : 0320006

Pilar, Buenos Aires, B1629ODT, Argentina

Location

Investigational Site Number : 0320004

Buenos Aires, C1118AAT, Argentina

Location

Investigational Site Number : 0320005

Córdoba, X5000JHQ, Argentina

Location

Investigational Site Number : 0320002

Córdoba, X5016KEH, Argentina

Location

LKH Steyr - Investigational Site Number : 0400002

Steyr, 4400, Austria

Location

Institut Jules Bordet - Investigational Site Number : 0560001

Anderlecht, 1070, Belgium

Location

AZ Nikolaas - Investigational Site Number : 0560002

Sint-Niklaas, 9100, Belgium

Location

Investigational Site Number : 1560002

Guangzhou, 510120, China

Location

Investigational Site Number : 1560001

Shenzhen, 518053, China

Location

Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007

Argenteuil, 95107, France

Location

Investigational Site Number : 2500017

Cahors, 46000, France

Location

Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006

Chambéry, 73000, France

Location

Clinique Louis Pasteur, Maison Médicale - Investigational Site Number : 2500012

Essey-lès-Nancy, 54270, France

Location

Centre Hospitalier Le Mans - Investigational Site Number : 2500015

Le Mans, 72037, France

Location

Investigational Site Number : 2500013

Lille, 59800, France

Location

Investigational Site Number : 2500004

Montpellier, 34295, France

Location

Investigational Site Number : 2500009

Pessac, 33604, France

Location

CHU Poitiers - Hôpital la Milétrie - Investigational Site Number : 2500008

Poitiers, 86021, France

Location

CHU Reims - Hôpital Robert Debré - Investigational Site Number : 2500010

Reims, 51092, France

Location

Investigational Site Number : 2500001

Rouen, 76038, France

Location

Investigational Site Number : 2500005

Saint-Priest-en-Jarez, 42270, France

Location

Investigational Site Number : 2500014

Saint-Quentin, 02321, France

Location

Investigational Site Number : 2500016

Tarbes, 65013, France

Location

Investigational Site Number : 2500011

Vannes, 56017, France

Location

Investigational Site Number : 2760016

Aschaffenburg, 63739, Germany

Location

Investigational Site Number : 2760020

Bamberg, 96052, Germany

Location

Investigational Site Number : 2760018

Bayreuth, 95445, Germany

Location

Investigational Site Number : 2760003

Berlin, 10117, Germany

Location

Investigational Site Number : 2760041

Berlin, 10437, Germany

Location

Praxis am Volkspark - Investigational Site Number : 2760009

Berlin, 10715, Germany

Location

Investigational Site Number : 2760022

Berlin, 12200, Germany

Location

MV Zentrum für Onkologie und Hämatologie - Investigational Site Number : 2760034

Cologne, 50677, Germany

Location

Investigational Site Number : 2760007

Donauwörth, 86609, Germany

Location

GEFOS Gesellschaft f. onkologische Studien -Investigational Site Number : 2760001

Dortmund, 44263, Germany

Location

Investigational Site Number : 2760002

Dresden, 01127, Germany

Location

Investigational Site Number : 2760035

Dresden, 01307, Germany

Location

Investigational Site Number : 2760037

Frankfurt, 60596, Germany

Location

Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus - Investigational Site Number : 2760010

Frankfurt am Main, 60389, Germany

Location

Investigational Site Number : 2760012

Hanover, 30449, Germany

Location

Investigational Site Number : 2760013

Herrsching am Ammersee, 82211, Germany

Location

Klinikum Kulmbach mit Fachklinik Stadtsteinach - Investigational Site Number : 2760026

Kulmbach, 95326, Germany

Location

Investigational Site Number : 2760008

Leipzig, 04289, Germany

Location

Philipps-Universitat Marburg, Klinic fur Innere Medizin -Investigational Site Number : 2760038

Marburg, 35037, Germany

Location

Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042

Mutlangen, 73557, Germany

Location

Investigational Site Number : 2760006

München, 81241, Germany

Location

Dietrich-Bonhoeffer-Klinikum - Investigational Site Number : 2760044

Neubrandenburg, 17036, Germany

Location

Investigational Site Number : 2760021

Oldenburg, 26121, Germany

Location

Investigational Site Number : 2760036

Oldenburg, 26133, Germany

Location

Klinikum Ernst von Bergmann gGmbH -Investigational Site Number : 2760039

Potsdam, 14467, Germany

Location

Investigational Site Number : 2760040

Stolberg, 52222, Germany

Location

Investigational Site Number : 2760031

Weilheim, 82362, Germany

Location

Investigational Site Number : 2760019

Würzburg, 97070, Germany

Location

Investigational Site Number : 3000005

Piraeus, 18537, Greece

Location

Investigational Site Number : 3440001

Hong Kong, Hong Kong

Location

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800009

Rome, Roma, 00133, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Umberto I - Investigational Site Number : 3800002

Rome, Roma, 00137, Italy

Location

Investigational Site Number : 3800006

Bari, 70124, Italy

Location

Istituto di Ematologia e Oncologia Medica - Investigational Site Number : 3800005

Bologna, 40138, Italy

Location

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800007

Brescia, 25123, Italy

Location

Investigational Site Number : 3800003

Milan, 20132, Italy

Location

Azienda Ospedaliera Universitaria "Federico II"-Investigational Site Number : 3800001

Napoli, 80138, Italy

Location

Investigational Site Number : 3800008

Novara, 28100, Italy

Location

Investigational Site Number : 3800013

Pavia, 27100, Italy

Location

Investigational Site Number : 3800004

Trento, 38122, Italy

Location

Investigational Site Number : 3800010

Treviso, 31100, Italy

Location

Investigational Site Number : 3920012

Sapporo, Hokkaido, 003-0006, Japan

Location

Investigational Site Number : 3920009

Osaka, Osaka, 543-8555, Japan

Location

Investigational Site Number : 3920003

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Investigational Site Number : 3920004

Minato-ku, Tokyo, 105-8470, Japan

Location

Investigational Site Number : 3920010

Fukuoka, 815-8555, Japan

Location

Investigational Site Number : 3920013

Minatoku, 105-8471, Japan

Location

Investigational Site Number : 3920005

Okayama, 701-1192, Japan

Location

Investigational Site Number : 3920014

Osakasayama-shi, 589-8511, Japan

Location

Investigational Site Number : 3920008

Shibukawa-shi, 377-0280, Japan

Location

Investigational Site Number : 3920011

Suwa-shi, 392-8510, Japan

Location

Investigational Site Number : 3920001

Yamagata, 990-9585, Japan

Location

Investigational Site Number : 4140001

Kuwait City, 42262, Kuwait

Location

Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001

Dordrecht, 3318 AT, Netherlands

Location

Puerto Rico Medical Research Center, LLC Site Number : 8400001

Hato Rey, 00917, Puerto Rico

Location

Auxilio Mutuo Cancer Center Site Number : 8400029

San Juan, 00917, Puerto Rico

Location

Investigational Site Number : 6430006

Volgograd, 400138, Russia

Location

Investigational Site Number : 6820005

Jeddah, 21423, Saudi Arabia

Location

Investigational Site Number : 6820004

Jeddah, 23431 6688, Saudi Arabia

Location

Investigational Site Number : 6820001

Khobar, 34234, Saudi Arabia

Location

Investigational Site Number : 6820002

Riyadh, 11426, Saudi Arabia

Location

Hospital Universitari Son Espases - Investigational Site Number : 7240003

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Complejo Asistencial Universitario de Leon Altos de Nava s/n. -Investigational Site Number : 7240005

León, León, 24071, Spain

Location

Hospital Regional Universitario de Malaga Hospital Regional Universitario de Malaga - Investigational Site Number : 7240006

Málaga, Málaga, 29010, Spain

Location

Hospital Universitario de Navarra - Investigational Site Number : 7240009

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Virgen de la Nieves - Investigational Site Number : 7240010

Granada, 18012, Spain

Location

Complejo Hospitalario Universitario de Pontevedra - Investigational Site Number : 7240011

Pontevedra, 36001, Spain

Location

omplejo Hospitalario Universitario de Canarias - Investigational Site Number : 7240007

San Cristóbal de La Laguna, 38320, Spain

Location

Investigational Site Number : 7240004

Toledo, 45003, Spain

Location

Kantonsspital Baden AG - Investigational Site Number : 5760003

Baden, 5404, Switzerland

Location

Investigational Site Number : 5760001

Bern, 3010, Switzerland

Location

Stadtspital Triemli - Investigational Site Number : 5760002

Zurich, 8063, Switzerland

Location

Investigational Site Number : 1580002

Kaohsiung City, 833401, Taiwan

Location

Investigational Site Number : 1580001

Taipei, 100, Taiwan

Location

Investigational Site Number : 7840002

Abu Dhabi, 11001, United Arab Emirates

Location

Investigational Site Number : 7840001

Abu Dhabi, 7400, United Arab Emirates

Location

Investigational Site Number : 8260002

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Investigational Site Number : 8260005

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Huddersfield Royal Infirmary - Investigational Site Number : 8260004

Huddersfield, HD3 3EA, United Kingdom

Location

Freeman Hospital - Investigational Site Number : 8260003

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

isatuximab; pomalidomide; Dexamethasone; carfilzomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 7, 2020
• Study Start: August 13, 2020
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

ES (8); HK (1); BE (2); FR (15); GR (1); US (24); AU (1); NL (1); RU (1); CH (3); DE (28); SA (4); IT (11); GB (4); PR (2); KU (1); AE (2); AR (5); TW (2); CN (2); JP (11)