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Brief Title: SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Official Title: 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)
Study ID: NCT05405166
Brief Summary: This is a 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 have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Detailed Description: Two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mohtaseb Cancer Center and Blood Disorders Site Number : 8400028, Bullhead City, Arizona, United States
Arizona Oncology Associates, PC - HAL Site Number : 8400015, Prescott Valley, Arizona, United States
Rocky Mountain Cancer Centers, LLP Site Number : 8400021, Aurora, Colorado, United States
Mayo Clinic Site Number : 8400008, Jacksonville, Florida, United States
BRCR Medical Center Inc Site Number : 8400030, Plantation, Florida, United States
Centre for Cancer and Blood Disorders Site Number : 8400026, Bethesda, Maryland, United States
Hattiesburg Clinic Site Number : 8400006, Hattiesburg, Mississippi, United States
Comprehensive Cancer Centers of Nevada Site Number : 8400019, Las Vegas, Nevada, United States
Atlantic Health System Site Number : 8400005, Morristown, New Jersey, United States
New York Oncology Hematology, P.C. Site Number : 8400017, Albany, New York, United States
Novant Health Site Number : 8400014, Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center Site Number : 8400114, Winston-Salem, North Carolina, United States
Gabrail Cancer Center Site Number : 8400027, Canton, Ohio, United States
Oncology_Hematology Care Clinical Trials, LLC Site Number : 8400016, Cincinnati, Ohio, United States
Oncology Associates Of Oregon, P.C. Site Number : 8400018, Eugene, Oregon, United States
Spoknwrd Clinical Trials Inc. Site Number : 8400023, Easton, Pennsylvania, United States
Gibbs Cancer Center-Spartanburg Medical Center Site Number : 8400002, Spartanburg, South Carolina, United States
Texas Oncology Baylor Sammons Site Number : 8400022, Dallas, Texas, United States
Lumi Research Site Number : 8400029, Kingwood, Texas, United States
Texas Oncology - San Antonio Site Number : 8400020, San Antonio, Texas, United States
George E. Wahlen Salt Lake City VA Medical Center Site Number : 8400011, Salt Lake City, Utah, United States
UW Cancer Center at ProHealth Care Site Number : 8400001, Waukesha, Wisconsin, United States
Investigational Site Number : 0320007, Caba, Buenos Aires, Argentina
Investigational Site Number : 0320001, Caba, Buenos Aires, Argentina
Investigational Site Number : 0320002, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Investigational Site Number : 0320006, La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320003, Caba, Ciudad De Buenos Aires, Argentina
Investigational Site Number : 0320008, Caba, Ciudad De Buenos Aires, Argentina
Investigational Site Number : 0320005, Caba, Ciudad De Buenos Aires, Argentina
Investigational Site Number : 0320010, Cordoba, Córdoba, Argentina
Investigational Site Number : 0320004, Buenos Aires, , Argentina
Investigational Site Number : 0320009, Mendoza, , Argentina
Investigational Site Number : 0360007, Liverpool, New South Wales, Australia
Investigational Site Number : 0360004, Waratah, New South Wales, Australia
Investigational Site Number : 0360003, Wollongong, New South Wales, Australia
Investigational Site Number : 0360008, Adelaide, South Australia, Australia
Investigational Site Number : 0360009, Fitzroy, Victoria, Australia
Investigational Site Number : 0360006, Melbourne, Victoria, Australia
Investigational Site Number : 0360001, Richmond, Victoria, Australia
NOHC - Nucleo de Oncologia e Hematologia do Ceara Site Number : 0760006, Fortaleza, Ceará, Brazil
OC ONCOCLINICAS MULTIHEMO ILHA DO LEITE Site Number : 0760007, Recife, Pernambuco, Brazil
CHN - Complexo Hospitalar de Niteroi Site Number : 0760008, Niteroi, Rio De Janeiro, Brazil
Hospital Mae de Deus Site Number : 0760003, Porto Alegre, Rio Grande Do Sul, Brazil
A Beneficencia Portuguesa de Sao Paulo - Hospital Beneficencia Portuguesa - BP Mirante Site Number : 0760002, Sao Paulo, São Paulo, Brazil
Clínica São Germano Site Number : 0760001, Sao Paulo, São Paulo, Brazil
Instituto COI de Educacao e Pesquisa Site Number : 0760004, Rio De Janeiro, , Brazil
Investigational Site Number : 1240001, Toronto, Ontario, Canada
Investigational Site Number : 1240004, Greenfield Park, Quebec, Canada
Investigational Site Number : 1240003, Montreal, Quebec, Canada
Investigational Site Number : 1520002, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520003, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520006, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520005, Viña del Mar, Valparaíso, Chile
Investigational Site Number : 1520004, Santiago, , Chile
Investigational Site Number : 1520001, Temuco, , Chile
Investigational Site Number : 1560001, Beijing, , China
Investigational Site Number : 1560022, Beijing, , China
Investigational Site Number : 1560010, Changsha, , China
Investigational Site Number : 1560006, Guangzhou, , China
Investigational Site Number : 1560002, Hangzhou, , China
Investigational Site Number : 1560020, Nanchang, , China
Investigational Site Number : 1560019, Nanning, , China
Investigational Site Number : 1560011, Qingdao, , China
Investigational Site Number : 1560017, Shanghai, , China
Investigational Site Number : 1560013, Shenyang, , China
Investigational Site Number : 1560021, Shenzhen, , China
Investigational Site Number : 1560007, Tianjin, , China
Investigational Site Number : 1560009, Tianjin, , China
Investigational Site Number : 1560018, Tianjin, , China
Investigational Site Number : 1560003, Wuhan, , China
Investigational Site Number : 1560008, Wuhan, , China
Investigational Site Number : 1560004, Zhengzhou, , China
Investigational Site Number : 2030005, Brno, , Czechia
Investigational Site Number : 2030003, Olomouc, , Czechia
Investigational Site Number : 2030006, Ostrava - Poruba, , Czechia
Investigational Site Number : 2030004, Praha 2, , Czechia
Investigational Site Number : 2500006, Lyon, , France
Investigational Site Number : 2500002, Nantes, , France
Investigational Site Number : 2500005, Paris, , France
Investigational Site Number : 2500008, Perigueux, , France
Investigational Site Number : 2500004, Pierre Benite, , France
Investigational Site Number : 2500001, Poitiers, , France
Investigational Site Number : 2500009, Saint-Etienne Cedex 2, , France
Investigational Site Number : 2500003, TOULOUSE Cedex 9, , France
Investigational Site Number : 2500007, Tours, , France
Investigational Site Number : 2760005, Dresden, , Germany
Investigational Site Number : 2760001, Hamburg, , Germany
Investigational Site Number : 2760003, Heidelberg, , Germany
Investigational Site Number : 2760006, Lübeck, , Germany
Investigational Site Number : 2760007, Nürnberg, , Germany
Investigational Site Number : 3000002, Athens, , Greece
Investigational Site Number : 3000001, Athens, , Greece
Investigational Site Number : 3000005, Ioannina, , Greece
Investigational Site Number : 3000003, Patra, , Greece
Investigational Site Number : 3000004, Thessaloniki, , Greece
Investigational Site Number : 3480002, Budapest, , Hungary
Investigational Site Number : 3480004, Budapest, , Hungary
Investigational Site Number : 3480003, Kaposvár, , Hungary
Investigational Site Number : 3480008, Pécs, , Hungary
Investigational Site Number : 3480005, Szekesfehervar, , Hungary
Investigational Site Number : 3480006, Szombathely, , Hungary
Investigational Site Number : 3800001, Meldola, Forlì-Cesena, Italy
Investigational Site Number : 3800004, Ancona, , Italy
Investigational Site Number : 3800002, Bologna, , Italy
Investigational Site Number : 3800005, Brescia, , Italy
Investigational Site Number : 3800007, Napoli, , Italy
Investigational Site Number : 3800008, Palermo, , Italy
Investigational Site Number : 3800003, Pavia, , Italy
Investigational Site Number : 3920001, Nagoya-shi, Aichi, Japan
Investigational Site Number : 3920007, Kamogawa-shi, Chiba, Japan
Investigational Site Number : 3920005, Higashiibaraki-gun, Ibaraki, Japan
Investigational Site Number : 3920010, Shiwa-gun, Iwate, Japan
Investigational Site Number : 3920012, Kamakura-shi, Kanagawa, Japan
Investigational Site Number : 3920003, Kyoto-shi, Kyoto, Japan
Investigational Site Number : 3920006, Natori-shi, Miyagi, Japan
Investigational Site Number : 3920002, Okayama-shi, Okayama, Japan
Investigational Site Number : 3920011, Osaka-shi, Osaka, Japan
Investigational Site Number : 3920008, Sunto-gun, Shizuoka, Japan
Investigational Site Number : 3920004, Shibuya-ku, Tokyo, Japan
Investigational Site Number : 3920009, Yamagata-shi, , Japan
Investigational Site Number : 5780001, Oslo, , Norway
Investigational Site Number : 5780002, Ålesund, , Norway
Investigational Site Number : 6160004, Wroclaw, Dolnoslaskie, Poland
Investigational Site Number : 6160005, Krakow, Malopolskie, Poland
Investigational Site Number : 6160001, Lublin, , Poland
Investigational Site Number : 6160003, Wroclaw, , Poland
Investigational Site Number : 7240003, Santander, Cantabria, Spain
Investigational Site Number : 7240004, Badalona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240007, Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240001, Pamplona, Navarra, Spain
Investigational Site Number : 7240005, Madrid, , Spain
Investigational Site Number : 7240006, Murcia, , Spain
Investigational Site Number : 7240002, Salamanca, , Spain
Investigational Site Number : 7520001, Borås, , Sweden
Investigational Site Number : 7520002, Stockholm, , Sweden
Investigational Site Number : 7520003, Stockholm, , Sweden
Investigational Site Number : 1580001, Kaohsiung, , Taiwan
Investigational Site Number : 1580005, Tainan, , Taiwan
Investigational Site Number : 1580002, Taipei, , Taiwan
Investigational Site Number : 7920007, Ankara, , Turkey
Investigational Site Number : 7920009, Ankara, , Turkey
Investigational Site Number : 7920004, Bornova, , Turkey
Investigational Site Number : 7920003, Istanbul, , Turkey
Investigational Site Number : 7920005, Istanbul, , Turkey
Investigational Site Number : 7920008, Istanbul, , Turkey
Investigational Site Number : 7920001, Istanbul, , Turkey
Investigational Site Number : 8260002, Leicester, Leicestershire, United Kingdom
Investigational Site Number : 8260005, London, London, City Of, United Kingdom
Investigational Site Number : 8260001, Norwich, Norfolk, United Kingdom
Investigational Site Number : 8260004, Birmingham, , United Kingdom
Investigational Site Number : 8260003, Derby, , United Kingdom
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR