NCT03275285CompletedPhase 3
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 302 (actual)
- First submitted
- 5 Sept 2017
- Start date
- 25 Oct 2017
- Primary completion date
- 14 Jan 2022
- Lead sponsor
- Sanofi
- Diseases
- Multiple myeloma
- NCT number
- NCT03275285
- EudraCT number
- 2017-001940-37
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 302
- From 25 Oct 2017 to the primary completion date, 14 Jan 2022
- 70 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants previously pretreated with carfilzomib, who never achieved at least one minor response during previous therapies and/or last previous therapy completed within 14 last days.
Other illness
- Participants with previous cancer unless disease free for more than 5 years or in situ cancer curatively treated.
- Participants with known acquired immunodeficiency syndrome related illness or human immunodeficiency virus requiring antiretroviral treatment, or hepatitis A, B, or C active infection.
Lab values
- Participants with serum free light chain (FLC) measurable disease only.
- Participants with myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or transient ischemic attack within last 6 months, and/or left ventricular ejection fraction lower than 40%.
Age
- Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2.
Other
- Participants with inadequate biological tests.
- Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Who the study is looking for
- Participants with MM previously treated with prior 1 to 3 lines and with measurable serum M-protein (\>= 0.5 gram/deciliter) and/or urine M-protein (\>= 200 milligram/24 hours).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (70)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigational Site Number : 0360005 Coordinator of this site? Confirm its status | Blacktown | Australia | Unknown status |
| Investigational Site Number : 0360001 Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Investigational Site Number : 0360004 Coordinator of this site? Confirm its status | Heidelberg West | Australia | Unknown status |
| Investigational Site Number : 0360007 Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Investigational Site Number : 0360006 Coordinator of this site? Confirm its status | Tweed Heads | Australia | Unknown status |
| Investigational Site Number : 0360008 Coordinator of this site? Confirm its status | West Perth | Australia | Unknown status |
| Investigational Site Number : 0360002 Coordinator of this site? Confirm its status | Wollongong | Australia | Unknown status |
| Hospital de Amor - Hospital do Cancer de Barretos - Fundacao Pio XII Site Number : 0760001 Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Hospital Mae de Deus- Site Number : 0760003 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto COI de Educacao e Pesquisa Site Number : 0760004 Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Hospital Sao Rafael - Rede D'OR Sao Luiz Site Number : 0760005 Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Hospital das Clinicas de Sao Paulo Site Number : 0760002 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Investigational Site Number : 1240002 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Investigational Site Number : 1240001 Coordinator of this site? Confirm its status | Saint John | Canada | Unknown status |
| Investigational Site Number : 1240003 Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| Investigational Site Number : 2030002 Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Investigational Site Number : 2030004 Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Investigational Site Number : 2030003 Coordinator of this site? Confirm its status | Ostrava - Poruba | Czechia | Unknown status |
| Investigational Site Number : 2030001 Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Investigational Site Number : 7240001 Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Investigational Site Number : 7240005 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Investigational Site Number : 7240003 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Investigational Site Number : 7240004 Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Investigational Site Number :7240002 Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Investigational Site Number :2500003 Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Investigational Site Number : 2500001 Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Investigational Site Number : 2500006 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Investigational Site Number : 2500002 Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Investigational Site Number : 2500005 Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Investigational Site Number : 2500004 Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Investigational Site Number : 8260001 Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Investigational Site Number : 8260005 Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Investigational Site Number : 8260004 Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Investigational Site Number : 3000001 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Investigational Site Number : 3000005 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Investigational Site Number : 3000002 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Investigational Site Number : 3000004 Coordinator of this site? Confirm its status | Pátrai | Greece | Unknown status |
| Investigational Site Number :3000003 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Investigational Site Number :3480003 Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Investigational Site Number : 3480004 Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Investigational Site Number :3480001 Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Investigational Site Number : 3480005 Coordinator of this site? Confirm its status | Kaposvár | Hungary | Unknown status |
| Investigational Site Number :3800003 Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Investigational Site Number : 3800001 Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Investigational Site Number : 3800004 Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| Investigational Site Number : 3800002 Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Investigational Site Number : 3920007 Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Investigational Site Number : 3920004 Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Unknown status |
| Investigational Site Number : 3920006 Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Investigational Site Number : 3920005 Coordinator of this site? Confirm its status | Shiwa-gun | Japan | Unknown status |
| Investigational Site Number : 3920003 Coordinator of this site? Confirm its status | Sunto-gun | Japan | Unknown status |
| Investigational Site Number : 3920001 Coordinator of this site? Confirm its status | Suwa-shi | Japan | Unknown status |
| Investigational Site Number : 3920002 Coordinator of this site? Confirm its status | Yamagata | Japan | Unknown status |
| Investigational Site Number : 4100006 Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Investigational Site Number : 4100002 Coordinator of this site? Confirm its status | Gangnam-gu | South Korea | Unknown status |
| Investigational Site Number : 4100004 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigational Site Number : 4100001 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigational Site Number : 4100005 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigational Site Number : 5540001 Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Investigational Site Number : 5540002 Coordinator of this site? Confirm its status | Wellington | New Zealand | Unknown status |
| Investigational Site Number : 6430003 Coordinator of this site? Confirm its status | Kirov | Russia | Unknown status |
| Investigational Site Number : 6430004 Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| Investigational Site Number : 6430002 Coordinator of this site? Confirm its status | Yekaterinburg | Russia | Unknown status |
| UCSF MS Center Site Number : 8400002 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Spartanburg Medical Center Site Number : 8400003 Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| Investigational Site Number : 7920003 Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920001 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920005 Coordinator of this site? Confirm its status | Bursa | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920002 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920004 Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.