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SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Sponsor: Sanofi
Summary
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
531
Start Date
2022-06-23
Completion Date
2027-10-22
Last Updated
2026-09-02
Healthy Volunteers
No
Conditions
Interventions
Isatuximab IV
Pharmaceutical form: Concentrate solution for IV infusion; Route of administration: Intravenous
Isatuximab SC
Pharmaceutical form: Solution for subcutaneous administration; Route of administration: Subcutaneous (SC)
Dexamethasone
Pharmaceutical form: Tablet; Route of administration: Oral
Pomalidomide
Pharmaceutical form: hard capsules; Route of administration: Oral
Dexamethasone
Pharmaceutical form: As per local commercial product; Route of administration: Oral; Auxiliary Medicinal Product (AxMP) i.e., background treatment; ATC code: H02AB02
Montelukast
Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: R03DC03
Paracetamol / Acetaminophen
Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: N02BE01
Diphenhydramine
Pharmaceutical form: As per local commercial product; Route of administration: As premedication- oral; for management of infusion reactions-IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: R06AA02
Methylprednisolone
Pharmaceutical form: As per local commercial product; Route of administration: As premedication-IV; for management of infusion reactions- IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: H02AB04
Locations (128)
Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
Aurora, Colorado, United States
Mayo Clinic in Florida- Site Number : 8400008
Jacksonville, Florida, United States
Boca Raton Clinical Research Associates- Site Number : 8400030
Plantation, Florida, United States
Hattiesburg Clinic- Site Number : 8400006
Hattiesburg, Mississippi, United States
Atlantic Health System- Site Number : 8400005
Morristown, New Jersey, United States
New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
Albany, New York, United States
Novant Health Neurology & Sleep- Site Number : 8400014
Charlotte, North Carolina, United States
Gabrail Cancer Center- Site Number : 8400027
Canton, Ohio, United States
Oncology Hematology Care - Fairfield- Site Number : 8400016
Fairfield, Ohio, United States
Spartanburg Regional Medical Center- Site Number : 8400002
Spartanburg, South Carolina, United States
University of Texas - Southwestern Medical Center- Site Number : 8400024
Dallas, Texas, United States
Texas Oncology - San Antonio Medical Center - Research Drive- Site Number : 8400020
San Antonio, Texas, United States
Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
Salt Lake City, Utah, United States
Investigational Site Number : 0320006
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320008
Buenos Aires, Argentina
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0320007
Buenos Aires, Argentina
Investigational Site Number : 0320003
Buenos Aires, Argentina
Investigational Site Number : 0320004
Buenos Aires, Argentina
Investigational Site Number : 0320001
Buenos Aires, Argentina
Investigational Site Number : 0320005
Buenos Aires, Argentina
Investigational Site Number : 0320010
Córdoba, 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 : 0360006
Melbourne, Victoria, Australia
Investigational Site Number : 0360009
Melbourne, Victoria, Australia
Investigational Site Number : 0360001
Richmond, Victoria, Australia
Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
Fortaleza, Ceará, Brazil
MultiHemo - Recife - Rua Padre Carapuceiro- Site Number : 0760007
Recife, Pernambuco, Brazil
CHN - Complexo Hospitalar de Niterói- Site Number : 0760008
Niterói, Rio de Janeiro, Brazil
Hospital Mae de Deus- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
Rio de Janeiro, Brazil
Clinica São Germano- Site Number : 0760001
São Paulo, 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 : 1520001
Temuco, La Araucanía, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520006
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Viña del Mar, Valparaiso, 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 : 1560013
Shenyang, 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, Czechia
Investigational Site Number : 2030004
Prague, Czechia
Investigational Site Number : 2500002
Nantes, France
Investigational Site Number : 2500005
Paris, France
Investigational Site Number : 2500001
Poitiers, France
Investigational Site Number : 2500009
Saint-Priest-en-Jarez, France
Investigational Site Number : 2500003
Toulouse, France
Investigational Site Number : 2500007
Tours, France
Investigational Site Number : 2760005
Dresden, Germany
Investigational Site Number : 2760003
Heidelberg, Germany
Investigational Site Number : 2760006
Lübeck, Germany
Investigational Site Number : 2760007
Nuremberg, Germany
Investigational Site Number : 3000002
Athens, Greece
Investigational Site Number : 3000001
Athens, Greece
Investigational Site Number : 3000003
Pátrai, 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
Székesfehérvár, Hungary
Investigational Site Number : 3480006
Szombathely, Hungary
Investigational Site Number : 3800004
Torette, Ancona, Italy
Investigational Site Number : 3800001
Meldola, Reggio Emilia, Italy
Investigational Site Number : 3800006
Rome, Roma, Italy
Investigational Site Number : 3800002
Bologna, Italy
Investigational Site Number : 3800005
Brescia, Italy
Investigational Site Number : 3800003
Pavia, Italy
Investigational Site Number : 3920001
Nagoya, Aichi-ken, Japan
Investigational Site Number : 3920007
Kamogawa, Chiba, Japan
Investigational Site Number : 3920005
Higashiibaraki, Ibaraki, Japan
Investigational Site Number : 3920010
Yahaba, Iwate, Japan
Investigational Site Number : 3920012
Kamakura, Kanagawa, Japan
Investigational Site Number : 3920002
Okayama, Okayama-ken, Japan
Investigational Site Number : 3920003
Kyoto, Japan
Investigational Site Number : 3920011
Osaka, Japan
Investigational Site Number : 3920004
Tokyo, Japan
Investigational Site Number : 3920009
Yamagata, Japan
Investigational Site Number : 5780002
Ålesund, Norway
Investigational Site Number : 5780001
Oslo, Norway
Investigational Site Number : 6160005
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160004
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160001
Lublin, Lublin Voivodeship, Poland
Investigational Site Number : 7240006
Murcia, Almería, Spain
Investigational Site Number : 7240004
Badalona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240003
Santander, Cantabria, Spain
Investigational Site Number : 7240001
Pamplona, Navarre, Spain
Investigational Site Number : 7240005
Madrid, Spain
Investigational Site Number : 7240002
Salamanca, Spain
Investigational Site Number : 7520001
Borås, Sweden
Investigational Site Number : 7520003
Huddinge, Sweden
Investigational Site Number : 1580001
Kaohsiung City, Taiwan
Investigational Site Number : 1580005
Tainan, Taiwan
Investigational Site Number : 1580002
Taipei, Taiwan
Investigational Site Number : 7920007
Ankara, Turkey (Türkiye)
Investigational Site Number : 7920009
Ankara, Turkey (Türkiye)
Investigational Site Number : 7920003
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920008
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920001
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920004
Izmir, Turkey (Türkiye)
Investigational Site Number : 8260003
Derby, Derbyshire, United Kingdom
Investigational Site Number : 8260004
Birmingham, England, United Kingdom
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