Clinical Research Directory
Browse clinical research sites, groups, and studies.
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Sponsor: Sanofi
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.
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
2027-03-23
Last Updated
2025-11-14
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 (146)
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
University of Texas Southwestern- Site Number : 8400024
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 Buenos Aires, Buenos Aires, Argentina
Investigational Site Number : 0320006
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320003
CABA, Buenos Aires F.D., Argentina
Investigational Site Number : 0320008
CABA, Buenos Aires F.D., Argentina
Investigational Site Number : 0320005
CABA, Buenos Aires F.D., Argentina
Investigational Site Number : 0320010
Córdoba, Córdoba Province, 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
Niterói, Rio de Janeiro, Brazil
Hospital Mae de Deus Site Number : 0760003
Porto Alegre, Rio Grande do Sul, Brazil
Clínica São Germano- Site Number : 0760001
São 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 : 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 : 1520005
Viña del Mar, Región de 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 : 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 - Poruba, Czechia
Investigational Site Number : 2030004
Prague, Czechia
Investigational Site Number : 2500002
Nantes, France
Investigational Site Number : 2500005
Paris, France
Investigational Site Number : 2500008
Périgueux, France
Investigational Site Number : 2500001
Poitiers, France
Investigational Site Number : 2500009
Saint-Etienne, France
Investigational Site Number : 2500003
Toulouse, 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
Nuremberg, Germany
Investigational Site Number : 3000002
Athens, Greece
Investigational Site Number : 3000001
Athens, Greece
Investigational Site Number : 3000005
Ioannina, 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 : 3800001
Meldola, Forlì-Cesena, Italy
Investigational Site Number : 3800006
Rome, Roma, Italy
Investigational Site Number : 3800004
Ancona, Italy
Investigational Site Number : 3800002
Bologna, Italy
Investigational Site Number : 3800005
Brescia, Italy
Investigational Site Number : 3800007
Naples, Italy
Investigational Site Number : 3800008
Palermo, Italy
Investigational Site Number : 3800003
Pavia, Italy
Investigational Site Number : 3920001
Nagoya, Aichi-ken, 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, Kyoto, Japan
Investigational Site Number : 3920006
Natori-shi, Miyagi, Japan
Investigational Site Number : 3920002
Okayama, Okayama-ken, Japan
Investigational Site Number : 3920011
Osaka, Osaka, Japan
Investigational Site Number : 3920008
Sunto-gun, Shizuoka, Japan
Investigational Site Number : 3920004
Shibuya-ku, 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, 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, Navarre, 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 : 7520003
Stockholm, 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 : 7920004
Bornova, 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 : 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