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Can a cancer drug's real-world performance match clinical trial results?

NCT ID NCT04458831

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This study tracks adults with relapsed or refractory multiple myeloma who are already receiving isatuximab as part of their routine care. Researchers will measure how many patients respond to treatment, how long the response lasts, and how the drug affects quality of life and side effects. The goal is to see if the benefits seen in earlier trials hold up in a broader, more diverse patient population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isatuximab (Sarclisa), often combined with pomalidomide, dexamethasone, or carfilzomib
What this could lead to
If the results are positive, this could confirm that isatuximab is effective and safe for treating multiple myeloma in real-world settings, beyond controlled trials.
What could go wrong
This is an observational study, not a controlled experiment, so it cannot prove cause and effect. Results may be influenced by patient selection and other treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

583 people

The number who actually took part.

Started

Aug 2020

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plasma cell myeloma

Contacts and locations

Locations

  • AMR Kansas City Site Number : 8400016

    Kansas City, Missouri, 64114, United States

  • AZ Nikolaas - Investigational Site Number : 0560002

    Sint-Niklaas, 9100, Belgium

  • Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001

    Dordrecht, 3318 AT, Netherlands

  • Auxilio Mutuo Cancer Center Site Number : 8400029

    San Juan, 00917, Puerto Rico

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

    Naples, 80138, Italy

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

    Rome, Roma, 00137, Italy

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

    Brescia, 25123, Italy

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

    Rome, Roma, 00133, Italy

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

    Poitiers, 86021, France

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

    Reims, 51092, France

  • Central Care Cancer Center Site Number : 8400006

    Garden City, Missouri, 67846, United States

  • Central Care Cancer Center Site Number : 8400019

    Garden City, Kansas, 67846, United States

  • Central Maine Medical Center Site Number : 8400031

    Lewiston, Maine, 04240, United States

  • Centre Hospitalier Le Mans - Investigational Site Number : 2500015

    Le Mans, 72037, France

  • Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006

    Chambéry, 73000, France

  • Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007

    Argenteuil, 95107, France

  • Charleston Hematology Oncology Associates, PA Site Number : 8400020

    Charleston, South Carolina, 29414, United States

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

    Essey-lès-Nancy, 54270, France

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

    León, León, 24071, Spain

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

    Pontevedra, 36001, Spain

  • Comprehensive Hematology Oncology Site Number : 8400026

    St. Petersburg, Florida, 33709, United States

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

    Neubrandenburg, 17036, Germany

  • Freeman Hospital - Investigational Site Number : 8260003

    Newcastle upon Tyne, NE7 7DN, United Kingdom

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

    Dortmund, 44263, Germany

  • GenesisCare Site Number : 8400007

    Jacksonville, Florida, 32204, United States

  • Hematology & Oncology Associates Site Number : 8400015

    Canton, Ohio, 44708, United States

  • Holy Cross Hospital Site Number : 8400030

    Fort Lauderdale, Florida, 33308, United States

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

    Málaga, Málaga, 29010, Spain

  • Hospital Universitari Son Espases - Investigational Site Number : 7240003

    Palma de Mallorca, Balearic Islands, 07120, Spain

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

    Granada, 18012, Spain

  • Hospital Universitario de Navarra - Investigational Site Number : 7240009

    Pamplona, Navarre, 31008, Spain

  • Huddersfield Royal Infirmary - Investigational Site Number : 8260004

    Huddersfield, HD3 3EA, United Kingdom

  • Institut Jules Bordet - Investigational Site Number : 0560001

    Anderlecht, 1070, Belgium

  • Investigational Site Number : 0320001

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1199, Argentina

  • Investigational Site Number : 0320002

    Córdoba, X5016KEH, Argentina

  • Investigational Site Number : 0320004

    Buenos Aires, C1118AAT, Argentina

  • Investigational Site Number : 0320005

    Córdoba, X5000JHQ, Argentina

  • Investigational Site Number : 0320006

    Pilar, Buenos Aires, B1629ODT, Argentina

  • Investigational Site Number : 1560001

    Shenzhen, 518053, China

  • Investigational Site Number : 1560002

    Guangzhou, 510120, China

  • Investigational Site Number : 1580001

    Taipei, 100, Taiwan

  • Investigational Site Number : 1580002

    Kaohsiung City, 833401, Taiwan

  • Investigational Site Number : 2500001

    Rouen, 76038, France

  • Investigational Site Number : 2500004

    Montpellier, 34295, France

  • Investigational Site Number : 2500005

    Saint-Priest-en-Jarez, 42270, France

  • Investigational Site Number : 2500009

    Pessac, 33604, France

  • Investigational Site Number : 2500011

    Vannes, 56017, France

  • Investigational Site Number : 2500013

    Lille, 59800, France

  • Investigational Site Number : 2500014

    Saint-Quentin, 02321, France

  • Investigational Site Number : 2500016

    Tarbes, 65013, France

  • Investigational Site Number : 2500017

    Cahors, 46000, France

  • Investigational Site Number : 2760002

    Dresden, 01127, Germany

  • Investigational Site Number : 2760003

    Berlin, 10117, Germany

  • Investigational Site Number : 2760006

    München, 81241, Germany

  • Investigational Site Number : 2760007

    Donauwörth, 86609, Germany

  • Investigational Site Number : 2760008

    Leipzig, 04289, Germany

  • Investigational Site Number : 2760012

    Hanover, 30449, Germany

  • Investigational Site Number : 2760013

    Herrsching am Ammersee, 82211, Germany

  • Investigational Site Number : 2760016

    Aschaffenburg, 63739, Germany

  • Investigational Site Number : 2760018

    Bayreuth, 95445, Germany

  • Investigational Site Number : 2760019

    Würzburg, 97070, Germany

  • Investigational Site Number : 2760020

    Bamberg, 96052, Germany

  • Investigational Site Number : 2760021

    Oldenburg, 26121, Germany

  • Investigational Site Number : 2760022

    Berlin, 12200, Germany

  • Investigational Site Number : 2760031

    Weilheim, 82362, Germany

  • Investigational Site Number : 2760035

    Dresden, 01307, Germany

  • Investigational Site Number : 2760036

    Oldenburg, 26133, Germany

  • Investigational Site Number : 2760037

    Frankfurt, 60596, Germany

  • Investigational Site Number : 2760040

    Stolberg, 52222, Germany

  • Investigational Site Number : 2760041

    Berlin, 10437, Germany

  • Investigational Site Number : 3000005

    Piraeus, 18537, Greece

  • Investigational Site Number : 3440001

    Hong Kong, Hong Kong

  • Investigational Site Number : 3800003

    Milan, 20132, Italy

  • Investigational Site Number : 3800004

    Trento, 38122, Italy

  • Investigational Site Number : 3800006

    Bari, 70124, Italy

  • Investigational Site Number : 3800008

    Novara, 28100, Italy

  • Investigational Site Number : 3800010

    Treviso, 31100, Italy

  • Investigational Site Number : 3800013

    Pavia, 27100, Italy

  • Investigational Site Number : 3920001

    Yamagata, 990-9585, Japan

  • Investigational Site Number : 3920003

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Investigational Site Number : 3920004

    Minato-ku, Tokyo, 105-8470, Japan

  • Investigational Site Number : 3920005

    Okayama, 701-1192, Japan

  • Investigational Site Number : 3920008

    Shibukawa-shi, 377-0280, Japan

  • Investigational Site Number : 3920009

    Osaka, Osaka, 543-8555, Japan

  • Investigational Site Number : 3920010

    Fukuoka, 815-8555, Japan

  • Investigational Site Number : 3920011

    Suwa-shi, 392-8510, Japan

  • Investigational Site Number : 3920012

    Sapporo, Hokkaido, 003-0006, Japan

  • Investigational Site Number : 3920013

    Minatoku, 105-8471, Japan

  • Investigational Site Number : 3920014

    Osakasayama-shi, 589-8511, Japan

  • Investigational Site Number : 4140001

    Kuwait City, 42262, Kuwait

  • Investigational Site Number : 5760001

    Bern, 3010, Switzerland

  • Investigational Site Number : 6430006

    Volgograd, 400138, Russia

  • Investigational Site Number : 6820001

    Khobar, 34234, Saudi Arabia

  • Investigational Site Number : 6820002

    Riyadh, 11426, Saudi Arabia

  • Investigational Site Number : 6820004

    Jeddah, 23431 6688, Saudi Arabia

  • Investigational Site Number : 6820005

    Jeddah, 21423, Saudi Arabia

  • Investigational Site Number : 7240004

    Toledo, 45003, Spain

  • Investigational Site Number : 7840001

    Abu Dhabi, 7400, United Arab Emirates

  • Investigational Site Number : 7840002

    Abu Dhabi, 11001, United Arab Emirates

  • Investigational Site Number : 8260002

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Investigational Site Number : 8260005

    Sutton, Surrey, SM2 5PT, United Kingdom

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

    Bologna, 40138, Italy

  • Kantonsspital Baden AG - Investigational Site Number : 5760003

    Baden, 5404, Switzerland

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

    Potsdam, 14467, Germany

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

    Kulmbach, 95326, Germany

  • Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042

    Mutlangen, 73557, Germany

  • LKH Steyr - Investigational Site Number : 0400002

    Steyr, 4400, Austria

  • MD Anderson Cancer Center Site Number : 8400013

    Houston, Texas, 77030-4000, United States

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

    Cologne, 50677, Germany

  • Michigan Center of Medical Research Site Number : 8400010

    Farmington Hills, Michigan, 48334, United States

  • Millennium Oncology Site Number : 8400025

    Pembroke Pines, Florida, 33024, United States

  • Novant Health Forsyth Medical Center Site Number : 8400028

    Winston-Salem, North Carolina, 27103, United States

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

    Frankfurt am Main, 60389, Germany

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

    Marburg, 35037, Germany

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

    Watertown, South Dakota, 57201-1548, United States

  • Praxis am Volkspark - Investigational Site Number : 2760009

    Berlin, 10715, Germany

  • Prisma Health - Eastside Office Site Number : 8400011

    Greenville, South Carolina, 29615, United States

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

    Hato Rey, 00917, Puerto Rico

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

    Little Silver, New Jersey, 07739, United States

  • Regional Cancer Care Associates Site Number : 8400024

    Howell Township, New Jersey, 07731, United States

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

    Freehold, New Jersey, 07728, United States

  • Renovatio Clinical Site Number : 8400004

    The Woodlands, Texas, 77380, United States

  • St. Joseph Heritage Healthcare Site Number : 8400008

    Fullerton, California, 92835, United States

  • Stadtspital Triemli - Investigational Site Number : 5760002

    Zurich, 8063, Switzerland

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

    Massillon, Ohio, 44646, United States

  • University of Arkansas Medical Sciences Site Number : 8400021

    Little Rock, Arkansas, 72205-7199, United States

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

    San Francisco, California, 94143, United States

  • Watson Clinic Cancer and Research Center Site Number : 8400023

    Lakeland, Florida, 33805, United States

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

    San Cristóbal de La Laguna, 38320, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.