NCT05405166Active, not recruitingPhase 3
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
This will be randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who will receive at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants were randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants are allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 531 (actual)
- First submitted
- 31 May 2022
- Start date
- 23 Jun 2022
- Primary completion date
- 6 Nov 2024
- Lead sponsor
- Sanofi
- Diseases
- Multiple myeloma
- NCT number
- NCT05405166
- EudraCT number
- 2023-508869-32
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 531
- From 23 Jun 2022 to the primary completion date, 6 Nov 2024
- 128 sites in 21 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 with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
- Prior therapy with pomalidomide
- Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
- Concomitant plasma cell leukemia
Other illness
- Significant cardiac dysfunction
- Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
- Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
Other
- Primary refractory multiple myeloma participants
- Participants with inadequate biological tests.
- Active primary amyloid light -chain amyloidosis
- 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 multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
- Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (\<0.26 or \>1.65)).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (128)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigational Site Number : 0320008 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigational Site Number : 0320005 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigational Site Number : 0320003 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigational Site Number : 0320004 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigational Site Number : 0320001 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigational Site Number : 0320002 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigational Site Number : 0320007 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigational Site Number : 0320010 Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Investigational Site Number : 0320006 Coordinator of this site? Confirm its status | La Plata | Argentina | Unknown status |
| Investigational Site Number : 0320009 Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Investigational Site Number : 0360008 Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Investigational Site Number : 0360007 Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Investigational Site Number : 0360006 Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Investigational Site Number : 0360009 Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Investigational Site Number : 0360001 Coordinator of this site? Confirm its status | Richmond | Australia | Unknown status |
| Investigational Site Number : 0360004 Coordinator of this site? Confirm its status | Waratah | Australia | Unknown status |
| Investigational Site Number : 0360003 Coordinator of this site? Confirm its status | Wollongong | Australia | Unknown status |
| Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006 Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| CHN - Complexo Hospitalar de Niterói- Site Number : 0760008 Coordinator of this site? Confirm its status | Niterói | Brazil | Unknown status |
| Hospital Mae de Deus- Site Number : 0760003 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| MultiHemo - Recife - Rua Padre Carapuceiro- Site Number : 0760007 Coordinator of this site? Confirm its status | Recife | Brazil | Unknown status |
| Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004 Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Clinica São Germano- Site Number : 0760001 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Investigational Site Number : 1240004 Coordinator of this site? Confirm its status | Greenfield Park | Canada | Unknown status |
| Investigational Site Number : 1240003 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Investigational Site Number : 1240001 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Investigational Site Number : 1520003 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Investigational Site Number : 1520004 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Investigational Site Number : 1520002 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Investigational Site Number : 1520006 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Investigational Site Number : 1520001 Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| Investigational Site Number : 1520005 Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Investigational Site Number : 1560001 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Investigational Site Number : 1560022 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Investigational Site Number : 1560010 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Investigational Site Number : 1560006 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Investigational Site Number : 1560002 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Investigational Site Number : 1560020 Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Investigational Site Number : 1560019 Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Investigational Site Number : 1560011 Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Investigational Site Number : 1560013 Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Investigational Site Number : 1560018 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Investigational Site Number : 1560007 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Investigational Site Number : 1560009 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Investigational Site Number : 1560008 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Investigational Site Number : 1560003 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Investigational Site Number : 1560004 Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Investigational Site Number : 2030005 Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Investigational Site Number : 2030003 Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Investigational Site Number : 2030006 Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Investigational Site Number : 2030004 Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Investigational Site Number : 2760005 Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Investigational Site Number : 2760003 Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Investigational Site Number : 2760006 Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Investigational Site Number : 2760007 Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
| Investigational Site Number : 7240004 Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Investigational Site Number : 7240005 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Investigational Site Number : 7240006 Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Investigational Site Number : 7240001 Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Investigational Site Number : 7240002 Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Investigational Site Number : 7240003 Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Investigational Site Number : 2500002 Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Investigational Site Number : 2500005 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Investigational Site Number : 2500001 Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Investigational Site Number : 2500009 Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| Investigational Site Number : 2500003 Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Investigational Site Number : 2500007 Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Investigational Site Number : 8260004 Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Investigational Site Number : 8260003 Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
| Investigational Site Number : 8260002 Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Investigational Site Number : 8260005 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Investigational Site Number : 8260001 Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
| Investigational Site Number : 3000002 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Investigational Site Number : 3000001 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Investigational Site Number : 3000003 Coordinator of this site? Confirm its status | Pátrai | Greece | Unknown status |
| Investigational Site Number : 3000004 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Investigational Site Number : 3480004 Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Investigational Site Number : 3480002 Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Investigational Site Number : 3480003 Coordinator of this site? Confirm its status | Kaposvár | Hungary | Unknown status |
| Investigational Site Number : 3480008 Coordinator of this site? Confirm its status | Pécs | Hungary | Unknown status |
| Investigational Site Number : 3480005 Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Unknown status |
| Investigational Site Number : 3480006 Coordinator of this site? Confirm its status | Szombathely | Hungary | Unknown status |
| Investigational Site Number : 3800002 Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Investigational Site Number : 3800005 Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Investigational Site Number : 3800001 Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Investigational Site Number : 3800003 Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Investigational Site Number : 3800006 Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Investigational Site Number : 3800004 Coordinator of this site? Confirm its status | Torette | Italy | Unknown status |
| Investigational Site Number : 3920005 Coordinator of this site? Confirm its status | Higashiibaraki | Japan | Unknown status |
| Investigational Site Number : 3920012 Coordinator of this site? Confirm its status | Kamakura | Japan | Unknown status |
| Investigational Site Number : 3920007 Coordinator of this site? Confirm its status | Kamogawa | Japan | Unknown status |
| Investigational Site Number : 3920003 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Investigational Site Number : 3920001 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Investigational Site Number : 3920002 Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Investigational Site Number : 3920011 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Investigational Site Number : 3920004 Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Investigational Site Number : 3920010 Coordinator of this site? Confirm its status | Yahaba | Japan | Unknown status |
| Investigational Site Number : 3920009 Coordinator of this site? Confirm its status | Yamagata | Japan | Unknown status |
| Investigational Site Number : 5780002 Coordinator of this site? Confirm its status | Ålesund | Norway | Unknown status |
| Investigational Site Number : 5780001 Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Investigational Site Number : 6160005 Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Investigational Site Number : 6160001 Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Investigational Site Number : 6160004 Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Investigational Site Number : 7520001 Coordinator of this site? Confirm its status | Borås | Sweden | Unknown status |
| Investigational Site Number : 7520003 Coordinator of this site? Confirm its status | Huddinge | Sweden | Unknown status |
| Investigational Site Number : 1580001 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Investigational Site Number : 1580005 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Investigational Site Number : 1580002 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017 Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021 Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Gabrail Cancer Center- Site Number : 8400027 Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Novant Health Neurology & Sleep- Site Number : 8400014 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University of Texas - Southwestern Medical Center- Site Number : 8400024 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Oncology Hematology Care - Fairfield- Site Number : 8400016 Coordinator of this site? Confirm its status | Fairfield | United States | Unknown status |
| Hattiesburg Clinic- Site Number : 8400006 Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Mayo Clinic in Florida- Site Number : 8400008 Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Atlantic Health System- Site Number : 8400005 Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Boca Raton Clinical Research Associates- Site Number : 8400030 Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Texas Oncology - San Antonio Medical Center - Research Drive- Site Number : 8400020 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Spartanburg Regional Medical Center- Site Number : 8400002 Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| Investigational Site Number : 7920007 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920009 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920008 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920003 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920001 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920005 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920004 Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.