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Plasma Cell MyelomaIONA-MMNCT04458831

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

An observational study of Plasma Cell Myeloma, run by Sanofi at 129 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plasma Cell Myeloma
What is being tested?
isatuximab SAR650984, Pomalidomide and Dexamethasone
How many people
583 participants
Where
129 sitesin 21 countries
Study dates
13 Aug 2020to 23 Feb 2026
How long will I take part?
30 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

  • 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.

Trial locations and contacts

129 sites in 21 countries.

129 sites in 21 countries

Germany28 sites

  • Investigational Site Number : 2760016

    Aschaffenburg, 63739

  • Investigational Site Number : 2760020

    Bamberg, 96052

  • Investigational Site Number : 2760018

    Bayreuth, 95445

  • Investigational Site Number : 2760003

    Berlin, 10117

  • Investigational Site Number : 2760041

    Berlin, 10437

  • Praxis am Volkspark - Investigational Site Number : 2760009

    Berlin, 10715

  • Investigational Site Number : 2760022

    Berlin, 12200

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

    Cologne, 50677

  • Investigational Site Number : 2760007

    Donauwörth, 86609

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

    Dortmund, 44263

  • Investigational Site Number : 2760002

    Dresden, 01127

  • Investigational Site Number : 2760035

    Dresden, 01307

  • Investigational Site Number : 2760037

    Frankfurt, 60596

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

    Frankfurt am Main, 60389

  • Investigational Site Number : 2760012

    Hanover, 30449

  • Investigational Site Number : 2760013

    Herrsching am Ammersee, 82211

  • Klinikum Kulmbach mit Fachklinik Stadtsteinach - Investigational Site Number : 2760026

    Kulmbach, 95326

  • Investigational Site Number : 2760008

    Leipzig, 04289

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

    Marburg, 35037

  • Investigational Site Number : 2760006

    München, 81241

  • Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042

    Mutlangen, 73557

  • Dietrich-Bonhoeffer-Klinikum - Investigational Site Number : 2760044

    Neubrandenburg, 17036

  • Investigational Site Number : 2760021

    Oldenburg, 26121

  • Investigational Site Number : 2760036

    Oldenburg, 26133

  • Klinikum Ernst von Bergmann gGmbH -Investigational Site Number : 2760039

    Potsdam, 14467

  • Investigational Site Number : 2760040

    Stolberg, 52222

  • Investigational Site Number : 2760031

    Weilheim, 82362

  • Investigational Site Number : 2760019

    Würzburg, 97070

Other trials in Germany

United States24 sites

  • Hematology & Oncology Associates Site Number : 8400015

    Canton, Ohio, 44708

  • Charleston Hematology Oncology Associates, PA Site Number : 8400020

    Charleston, South Carolina, 29414

  • Michigan Center of Medical Research Site Number : 8400010

    Farmington Hills, Michigan, 48334

  • Holy Cross Hospital Site Number : 8400030

    Fort Lauderdale, Florida, 33308

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

    Freehold, New Jersey, 07728

  • St. Joseph Heritage Healthcare Site Number : 8400008

    Fullerton, California, 92835

  • Central Care Cancer Center Site Number : 8400019

    Garden City, Kansas, 67846

  • Central Care Cancer Center Site Number : 8400006

    Garden City, Missouri, 67846

  • Prisma Health - Eastside Office Site Number : 8400011

    Greenville, South Carolina, 29615

  • MD Anderson Cancer Center Site Number : 8400013

    Houston, Texas, 77030-4000

  • Regional Cancer Care Associates Site Number : 8400024

    Howell Township, New Jersey, 07731

  • GenesisCare Site Number : 8400007

    Jacksonville, Florida, 32204

  • AMR Kansas City Site Number : 8400016

    Kansas City, Missouri, 64114

  • Watson Clinic Cancer and Research Center Site Number : 8400023

    Lakeland, Florida, 33805

  • Central Maine Medical Center Site Number : 8400031

    Lewiston, Maine, 04240

  • University of Arkansas Medical Sciences Site Number : 8400021

    Little Rock, Arkansas, 72205-7199

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

    Little Silver, New Jersey, 07739

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

    Massillon, Ohio, 44646

  • Millennium Oncology Site Number : 8400025

    Pembroke Pines, Florida, 33024

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

    San Francisco, California, 94143

  • Comprehensive Hematology Oncology Site Number : 8400026

    St. Petersburg, Florida, 33709

  • Renovatio Clinical Site Number : 8400004

    The Woodlands, Texas, 77380

  • Prairie Lakes Health Care System, Inc Site Number : 8400002

    Watertown, South Dakota, 57201-1548

  • Novant Health Forsyth Medical Center Site Number : 8400028

    Winston-Salem, North Carolina, 27103

Other trials in United States

France15 sites

  • Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007

    Argenteuil, 95107

  • Investigational Site Number : 2500017

    Cahors, 46000

  • Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006

    Chambéry, 73000

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

    Essey-lès-Nancy, 54270

  • Centre Hospitalier Le Mans - Investigational Site Number : 2500015

    Le Mans, 72037

  • Investigational Site Number : 2500013

    Lille, 59800

  • Investigational Site Number : 2500004

    Montpellier, 34295

  • Investigational Site Number : 2500009

    Pessac, 33604

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

    Poitiers, 86021

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

    Reims, 51092

  • Investigational Site Number : 2500001

    Rouen, 76038

  • Investigational Site Number : 2500005

    Saint-Priest-en-Jarez, 42270

  • Investigational Site Number : 2500014

    Saint-Quentin, 02321

  • Investigational Site Number : 2500016

    Tarbes, 65013

  • Investigational Site Number : 2500011

    Vannes, 56017

Other trials in France

Italy11 sites

  • Investigational Site Number : 3800006

    Bari, 70124

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

    Bologna, 40138

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

    Brescia, 25123

  • Investigational Site Number : 3800003

    Milan, 20132

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

    Naples, 80138

  • Investigational Site Number : 3800008

    Novara, 28100

  • Investigational Site Number : 3800013

    Pavia, 27100

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

    Rome, Roma, 00133

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

    Rome, Roma, 00137

  • Investigational Site Number : 3800004

    Trento, 38122

  • Investigational Site Number : 3800010

    Treviso, 31100

Other trials in Italy

Japan11 sites

  • Investigational Site Number : 3920010

    Fukuoka, 815-8555

  • Investigational Site Number : 3920004

    Minato-ku, Tokyo, 105-8470

  • Investigational Site Number : 3920013

    Minatoku, 105-8471

  • Investigational Site Number : 3920005

    Okayama, 701-1192

  • Investigational Site Number : 3920009

    Osaka, Osaka, 543-8555

  • Investigational Site Number : 3920014

    Osakasayama-shi, 589-8511

  • Investigational Site Number : 3920012

    Sapporo, Hokkaido, 003-0006

  • Investigational Site Number : 3920008

    Shibukawa-shi, 377-0280

  • Investigational Site Number : 3920003

    Sunto-gun, Shizuoka, 411-8777

  • Investigational Site Number : 3920011

    Suwa-shi, 392-8510

  • Investigational Site Number : 3920001

    Yamagata, 990-9585

Other trials in Japan

Spain8 sites

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

    Granada, 18012

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

    León, León, 24071

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

    Málaga, Málaga, 29010

  • Hospital Universitari Son Espases - Investigational Site Number : 7240003

    Palma de Mallorca, Balearic Islands, 07120

  • Hospital Universitario de Navarra - Investigational Site Number : 7240009

    Pamplona, Navarre, 31008

  • Complejo Hospitalario Universitario de Pontevedra - Investigational Site Number : 7240011

    Pontevedra, 36001

  • omplejo Hospitalario Universitario de Canarias - Investigational Site Number : 7240007

    San Cristóbal de La Laguna, 38320

  • Investigational Site Number : 7240004

    Toledo, 45003

Other trials in Spain

Argentina5 sites

  • Investigational Site Number : 0320004

    Buenos Aires, C1118AAT

  • Investigational Site Number : 0320001

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1199

  • Investigational Site Number : 0320005

    Córdoba, X5000JHQ

  • Investigational Site Number : 0320002

    Córdoba, X5016KEH

  • Investigational Site Number : 0320006

    Pilar, Buenos Aires, B1629ODT

Other trials in Argentina

Saudi Arabia4 sites

  • Investigational Site Number : 6820005

    Jeddah, 21423

  • Investigational Site Number : 6820004

    Jeddah, 23431 6688

  • Investigational Site Number : 6820001

    Khobar, 34234

  • Investigational Site Number : 6820002

    Riyadh, 11426

Other trials in Saudi Arabia

United Kingdom4 sites

  • Huddersfield Royal Infirmary - Investigational Site Number : 8260004

    Huddersfield, HD3 3EA

  • Freeman Hospital - Investigational Site Number : 8260003

    Newcastle upon Tyne, NE7 7DN

  • Investigational Site Number : 8260002

    Nottingham, Nottinghamshire, NG5 1PB

  • Investigational Site Number : 8260005

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Switzerland3 sites

  • Kantonsspital Baden AG - Investigational Site Number : 5760003

    Baden, 5404

  • Investigational Site Number : 5760001

    Bern, 3010

  • Stadtspital Triemli - Investigational Site Number : 5760002

    Zurich, 8063

Other trials in Switzerland

Belgium2 sites

  • Institut Jules Bordet - Investigational Site Number : 0560001

    Anderlecht, 1070

  • AZ Nikolaas - Investigational Site Number : 0560002

    Sint-Niklaas, 9100

Other trials in Belgium

China2 sites

  • Investigational Site Number : 1560002

    Guangzhou, 510120

  • Investigational Site Number : 1560001

    Shenzhen, 518053

Other trials in China

Puerto Rico2 sites

  • Puerto Rico Medical Research Center, LLC Site Number : 8400001

    Hato Rey, 00917

  • Auxilio Mutuo Cancer Center Site Number : 8400029

    San Juan, 00917

Other trials in Puerto Rico

Taiwan2 sites

  • Investigational Site Number : 1580002

    Kaohsiung City, 833401

  • Investigational Site Number : 1580001

    Taipei, 100

Other trials in Taiwan

United Arab Emirates2 sites

  • Investigational Site Number : 7840002

    Abu Dhabi, 11001

  • Investigational Site Number : 7840001

    Abu Dhabi, 7400

Other trials in United Arab Emirates

Austria1 site

  • LKH Steyr - Investigational Site Number : 0400002

    Steyr, 4400

Other trials in Austria

Greece1 site

  • Investigational Site Number : 3000005

    Piraeus, 18537

Other trials in Greece

Hong Kong1 site

  • Investigational Site Number : 3440001

    Hong Kong

Other trials in Hong Kong

Kuwait1 site

  • Investigational Site Number : 4140001

    Kuwait City, 42262

Other trials in Kuwait

Netherlands1 site

  • Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001

    Dordrecht, 3318 AT

Other trials in Netherlands

Russia1 site

  • Investigational Site Number : 6430006

    Volgograd, 400138

Other trials in Russia

About this study

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

Read more

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

Read the detailed description

Duration per participant is 2.5 years

Being tested
isatuximab SAR650984, Pomalidomide, Dexamethasone, Carfilzomib
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • isatuximab SAR650984Drug

    Also called Sarclisa

    Pharmaceutical form: solution for infusion

    Route of administration: intravenous

  • PomalidomideDrug

    Also called Pomalyst

    Pharmaceutical form: oral

  • DexamethasoneDrug

    Pharmaceutical form: oral

  • CarfilzomibDrug

    Pharmaceutical form: solution for infusion

Study groups in NCT04458831
Study groupRoleWhat they receive
Cohort 1Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria
Receives: Drug: isatuximab SAR650984; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Carfilzomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

  2. 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.

    Measured: Up to 30 months

  3. Progression free survival rate (PFSR)

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

    Measured: up to 18 months

  4. 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.

    Measured: Up to 30 months

  5. 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

    Measured: Up to 30 months

  6. Time to first subsequent anti-myeloma therapy

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

    Measured: Up to 30 months

  7. Rate of very good partial response or better

    Comprising VGPR, CR, and sCR within 12 months

    Measured: 12 months

  8. Rate of complete response (CR) or better

    Comprising CR and sCR responses within 12 months

    Measured: 12 months

  9. 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

    Measured: Up to 1 month after the end of treatment

  10. 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.

    Measured: through end of treatment (up to approximately 2 years)

  11. 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).

    Measured: through end of treatment (up to approximately 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start13 Aug 2020
  3. Primary completion23 Feb 2026
  4. Study completion23 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
583 participants (actual)
Target duration
30 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04458831
Sponsor's protocol ID
OBS16577
Acronym
IONA-MM
Status last verified
Jul 2026
First submitted
25 Jun 2020
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

An observational study of Plasma Cell Myeloma, run by Sanofi at 129 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in Germany, United States, France, Italy, Japan and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: 12 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04458831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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