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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Plasma Cell Myeloma
• Intervention / Treatment: Drug: isatuximab SAR650984; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Carfilzomib

Detailed Description

Duration per participant is 2.5 years

• Study Type: Observational
• Enrollment (Actual): 583

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1118AAT
    • Investigational Site Number : 0320004
  • Cordoba, Argentina, X5000JHQ
    • Investigational Site Number : 0320005
  • Cordoba, Argentina, X5016KEH
    • Investigational Site Number : 0320002
  • Buenos Aires
    • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1199
      • Investigational Site Number : 0320001
    • Pilar, Buenos Aires, Argentina, B1629ODT
      • Investigational Site Number : 0320006
• Austria
  • Steyr, Austria, 4400
    • LKH Steyr - Investigational Site Number : 0400002
• Belgium
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet - Investigational Site Number : 0560001
  • Sint Niklaas, Belgium, 9100
    • AZ Nikolaas - Investigational Site Number : 0560002
• China
  • Guangzhou, China, 510120
    • Investigational Site Number : 1560002
  • Shenzhen, China, 518053
    • Investigational Site Number : 1560001
• France
  • Argenteuil, France, 95107
    • Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007
  • Cahors, France, 46000
    • Investigational Site Number : 2500017
  • Chambéry, France, 73000
    • Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006
  • Essey les Nancy, France, 54270
    • Clinique Louis Pasteur, Maison Médicale - Investigational Site Number : 2500012
  • Le Mans Cedex, France, 72037
    • Centre Hospitalier Le Mans - Investigational Site Number : 2500015
  • Lille, France, 59800
    • Investigational Site Number : 2500013
  • Montpellier Cedex 5, France, 34295
    • Investigational Site Number : 2500004
  • Pessac cedex, France, 33604
    • Investigational Site Number : 2500009
  • Poitiers, France, 86021
    • CHU Poitiers - Hôpital la Milétrie - Investigational Site Number : 2500008
  • Reims, France, 51092
    • CHU Reims - Hôpital Robert Debré - Investigational Site Number : 2500010
  • Rouen, France, 76038
    • Investigational Site Number : 2500001
  • Saint Priest En Jarez, France, 42270
    • Investigational Site Number : 2500005
  • Saint Quentin cedex, France, 02321
    • Investigational Site Number : 2500014
  • Tarbes, France, 65013
    • Investigational Site Number : 2500016
  • Vannes Cedex, France, 56017
    • Investigational Site Number : 2500011
• Germany
  • Aschaffenburg, Germany, 63739
    • Investigational Site Number : 2760016
  • Bamberg, Germany, 96052
    • Investigational Site Number : 2760020
  • Bayreuth, Germany, 95445
    • Investigational Site Number : 2760018
  • Berlin, Germany, 10117
    • Investigational Site Number : 2760003
  • Berlin, Germany, 10437
    • Investigational Site Number : 2760041
  • Berlin, Germany, 10715
    • Praxis am Volkspark - Investigational Site Number : 2760009
  • Berlin, Germany, 12200
    • Investigational Site Number : 2760022
  • Donauwoerth, Germany, 86609
    • Investigational Site Number : 2760007
  • Dortmund, Germany, 44263
    • GEFOS Gesellschaft f. onkologische Studien -Investigational Site Number : 2760001
  • Dresden, Germany, 01127
    • Investigational Site Number : 2760002
  • Dresden, Germany, 01307
    • Investigational Site Number : 2760035
  • Frankfurt, Germany, 60596
    • Investigational Site Number : 2760037
  • Frankfurt am Main, Germany, 60389
    • Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus - Investigational Site Number : 2760010
  • Hannover, Germany, 30449
    • Investigational Site Number : 2760012
  • Herrsching, Germany, 82211
    • Investigational Site Number : 2760013
  • Koeln, Germany, 50677
    • MV Zentrum für Onkologie und Hämatologie - Investigational Site Number : 2760034
  • Kulmbach, Germany, 95326
    • Klinikum Kulmbach mit Fachklinik Stadtsteinach - Investigational Site Number : 2760026
  • Leipzig, Germany, 04289
    • Investigational Site Number : 2760008
  • Marburg, Germany, 35037
    • Philipps-Universitat Marburg, Klinic fur Innere Medizin -Investigational Site Number : 2760038
  • Muenchen, Germany, 81241
    • Investigational Site Number : 2760006
  • Mutlangen, Germany, 73557
    • Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042
  • Neubrandenburg, Germany, 17036
    • Dietrich-Bonhoeffer-Klinikum - Investigational Site Number : 2760044
  • Oldenburg, Germany, 26121
    • Investigational Site Number : 2760021
  • Oldenburg, Germany, 26133
    • Investigational Site Number : 2760036
  • Potsdam, Germany, 14467
    • Klinikum Ernst von Bergmann gGmbH -Investigational Site Number : 2760039
  • Stolberg, Germany, 52222
    • Investigational Site Number : 2760040
  • Weilheim, Germany, 82362
    • Investigational Site Number : 2760031
  • Wuerzburg, Germany, 97070
    • Investigational Site Number : 2760019
• Greece
  • Piraeus, Greece, 18537
    • Investigational Site Number : 3000005
• Hong Kong
  • Hong Kong, Hong Kong
    • Investigational Site Number : 3440001
• Italy
  • Bari, Italy, 70124
    • Investigational Site Number : 3800006
  • Bologna, Italy, 40138
    • Istituto di Ematologia e Oncologia Medica - Investigational Site Number : 3800005
  • Brescia, Italy, 25123
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800007
  • Milan, Italy, 20132
    • Investigational Site Number : 3800003
  • Napoli, Italy, 80138
    • Azienda Ospedaliera Universitaria "Federico II"-Investigational Site Number : 3800001
  • Novara, Italy, 28100
    • Investigational Site Number : 3800008
  • Pavia, Italy, 27100
    • Investigational Site Number : 3800013
  • Trento, Italy, 38122
    • Investigational Site Number : 3800004
  • Treviso, Italy, 31100
    • Investigational Site Number : 3800010
  • Roma
    • Rome, Roma, Italy, 00133
      • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800009
    • Rome, Roma, Italy, 00137
      • Azienda Ospedaliera Universitaria Policlinico Umberto I - Investigational Site Number : 3800002
• Japan
  • Fukuoka-shi, Japan, 815-8555
    • Investigational Site Number : 3920010
  • Minato-ku, Japan, 105-8471
    • Investigational Site Number : 3920013
  • Okayama-shi, Japan, 701-1192
    • Investigational Site Number : 3920005
  • Osakasayama-shi, Japan, 589-8511
    • Investigational Site Number : 3920014
  • Shibukawa-shi, Japan, 377-0280
    • Investigational Site Number : 3920008
  • Suwa-shi, Japan, 392-8510
    • Investigational Site Number : 3920011
  • Yamagata-shi, Japan, 990-9585
    • Investigational Site Number : 3920001
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 003-0006
      • Investigational Site Number : 3920012
  • Osaka
    • Osaka-shi, Osaka, Japan, 543-8555
      • Investigational Site Number : 3920009
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Investigational Site Number : 3920003
  • Tokyo
    • Minato-ku, Tokyo, Japan, 105-8470
      • Investigational Site Number : 3920004
• Kuwait
  • Kuwait, Kuwait, 42262
    • Investigational Site Number : 4140001
• Netherlands
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001
• Puerto Rico
  • Hato Rey, Puerto Rico, 00917
    • Puerto Rico Medical Research Center, LLC Site Number : 8400001
  • San Juan, Puerto Rico, 00917
    • Auxilio Mutuo Cancer Center Site Number : 8400029
• Russian Federation
  • Volgograd, Russian Federation, 400138
    • Investigational Site Number : 6430006
• Saudi Arabia
  • Jeddah, Saudi Arabia, 21423
    • Investigational Site Number : 6820005
  • Jeddah, Saudi Arabia, 23431 6688
    • Investigational Site Number : 6820004
  • Khobar, Saudi Arabia, 34234
    • Investigational Site Number : 6820001
  • Riyadh, Saudi Arabia, 11426
    • Investigational Site Number : 6820002
• Spain
  • Granada, Spain, 18012
    • Hospital Universitario Virgen de la Nieves - Investigational Site Number : 7240010
  • Pontevedra, Spain, 36001
    • Complejo Hospitalario Universitario de Pontevedra - Investigational Site Number : 7240011
  • San Cristobal De La Laguna, Spain, 38320
    • omplejo Hospitalario Universitario de Canarias - Investigational Site Number : 7240007
  • Toledo, Spain, 45003
    • Investigational Site Number : 7240004
  • Baleares
    • Palma de Mallorca, Baleares, Spain, 07120
      • Hospital Universitari Son Espases - Investigational Site Number : 7240003
  • León
    • Leon, León, Spain, 24071
      • Complejo Asistencial Universitario de Leon Altos de Nava s/n. -Investigational Site Number : 7240005
  • Málaga
    • Malaga, Málaga, Spain, 29010
      • Hospital Regional Universitario de Malaga Hospital Regional Universitario de Malaga - Investigational Site Number : 7240006
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital Universitario de Navarra - Investigational Site Number : 7240009
• Switzerland
  • Baden, Switzerland, 5404
    • Kantonsspital Baden AG - Investigational Site Number : 5760003
  • Bern, Switzerland, 3010
    • Investigational Site Number : 5760001
  • Zürich, Switzerland, 8063
    • Stadtspital Triemli - Investigational Site Number : 5760002
• Taiwan
  • Kaohsiung, Taiwan, 833401
    • Investigational Site Number : 1580002
  • Taipei, Taiwan, 100
    • Investigational Site Number : 1580001
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 11001
    • Investigational Site Number : 7840002
  • Abu dhabi, United Arab Emirates, 7400
    • Investigational Site Number : 7840001
• United Kingdom
  • Huddersfield, United Kingdom, HD3 3EA
    • Huddersfield Royal Infirmary - Investigational Site Number : 8260004
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital - Investigational Site Number : 8260003
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Investigational Site Number : 8260002
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Investigational Site Number : 8260005
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205-7199
      • University of Arkansas Medical Sciences Site Number : 8400021
  • California
    • Fullerton, California, United States, 92835
      • St. Joseph Heritage Healthcare Site Number : 8400008
    • San Francisco, California, United States, 94143
      • University of California San Francisco (PARENT) Site Number : 8400009
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital Site Number : 8400030
    • Jacksonville, Florida, United States, 32204
      • GenesisCare Site Number : 8400007
    • Lakeland, Florida, United States, 33805
      • Watson Clinic Cancer and Research Center Site Number : 8400023
    • Pembroke Pines, Florida, United States, 33024
      • Millennium Oncology Site Number : 8400025
    • Saint Petersburg, Florida, United States, 33709
      • Comprehensive Hematology Oncology Site Number : 8400026
  • Kansas
    • Garden City, Kansas, United States, 67846
      • Central Care Cancer Center Site Number : 8400019
  • Maine
    • Lewiston, Maine, United States, 04240
      • Central Maine Medical Center Site Number : 8400031
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Center of Medical Research Site Number : 8400010
  • Missouri
    • Garden City, Missouri, United States, 67846
      • Central Care Cancer Center Site Number : 8400006
    • Kansas City, Missouri, United States, 64114
      • AMR Kansas City Site Number : 8400016
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017
    • Howell, New Jersey, United States, 07731
      • Regional Cancer Care Associates Site Number : 8400024
    • Little Silver, New Jersey, United States, 07739
      • Regional Cancer Care Associates - Little Silver Division Site Number : 8400018
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center Site Number : 8400028
  • Ohio
    • Canton, Ohio, United States, 44708
      • Hematology & Oncology Associates Site Number : 8400015
    • Massillon, Ohio, United States, 44646
      • Tri County Hematology & Oncology Associates, Inc Site Number : 8400012
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Hematology Oncology Associates, PA Site Number : 8400020
    • Greenville, South Carolina, United States, 29615
      • Prisma Health - Eastside Office Site Number : 8400011
  • South Dakota
    • Watertown, South Dakota, United States, 57201-1548
      • Prairie Lakes Health Care System, Inc Site Number : 8400002
  • Texas
    • Houston, Texas, United States, 77030-4000
      • MD Anderson Cancer Center Site Number : 8400013
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical Site Number : 8400004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

• Age ≥18 years or country's legal age of majority if the legal age is >18 years old at the time of enrollment
• 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 or whose treatment is still ongoing at 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. Further eligibility criteria might apply.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Other Names: Sarclisa; Drug: Pomalidomide; Pharmaceutical form: oral; Other Names: Pomalyst; Drug: Dexamethasone; Pharmaceutical form: oral; Drug: Carfilzomib; Pharmaceutical form: solution for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Estimated): February 23, 2026
• Study Completion (Estimated): February 23, 2026

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Pomalidomide
• Other Study ID Numbers: OBS16577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No