Multiple Myeloma Clinical Trial

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

Summary

This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of treatment-a-promising-new-option-for-relapsed-multiple-myeloma/" >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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)).

Exclusion Criteria:

Primary refractory multiple myeloma participants
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 with inadequate biological tests.
Significant cardiac dysfunction
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
Active primary amyloid light -chain amyloidosis
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.
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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

534

Study ID:

NCT05405166

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 150 Locations for this study

See Locations Near You

Mohtaseb Cancer Center and Blood Disorders Site Number : 8400028
Bullhead City Arizona, 86442, United States
Arizona Oncology Associates, PC - HAL Site Number : 8400015
Prescott Valley Arizona, 86314, United States
Rocky Mountain Cancer Centers, LLP Site Number : 8400021
Aurora Colorado, 80012, United States
Mayo Clinic Site Number : 8400008
Jacksonville Florida, 32224, United States
BRCR Medical Center Inc Site Number : 8400030
Plantation Florida, 33322, United States
Centre for Cancer and Blood Disorders Site Number : 8400026
Bethesda Maryland, 20817, United States
Hattiesburg Clinic Site Number : 8400006
Hattiesburg Mississippi, 39401, United States
Comprehensive Cancer Centers of Nevada Site Number : 8400019
Las Vegas Nevada, 89169, United States
Atlantic Health System Site Number : 8400005
Morristown New Jersey, 07960, United States
New York Oncology Hematology, P.C. Site Number : 8400017
Albany New York, 12206, United States
Novant Health Site Number : 8400014
Charlotte North Carolina, 28207, United States
Novant Health Forsyth Medical Center Site Number : 8400114
Winston-Salem North Carolina, 27103, United States
Gabrail Cancer Center Site Number : 8400027
Canton Ohio, 44718, United States
Oncology_Hematology Care Clinical Trials, LLC Site Number : 8400016
Cincinnati Ohio, 45236, United States
Oncology Associates Of Oregon, P.C. Site Number : 8400018
Eugene Oregon, 97401, United States
Spoknwrd Clinical Trials Inc. Site Number : 8400023
Easton Pennsylvania, 18045, United States
Gibbs Cancer Center-Spartanburg Medical Center Site Number : 8400002
Spartanburg South Carolina, 29303, United States
Texas Oncology Baylor Sammons Site Number : 8400022
Dallas Texas, 75246, United States
Lumi Research Site Number : 8400029
Kingwood Texas, 77339, United States
Texas Oncology - San Antonio Site Number : 8400020
San Antonio Texas, 78240, United States
George E. Wahlen Salt Lake City VA Medical Center Site Number : 8400011
Salt Lake City Utah, 84148, United States
UW Cancer Center at ProHealth Care Site Number : 8400001
Waukesha Wisconsin, 53188, United States
Investigational Site Number : 0320007
Caba Buenos Aires, 1280, Argentina
Investigational Site Number : 0320001
Caba Buenos Aires, 1430, Argentina
Investigational Site Number : 0320002
Ciudad Autonoma de Buenos Aires Buenos Aires, C1181, Argentina
Investigational Site Number : 0320006
La Plata Buenos Aires, 1900, Argentina
Investigational Site Number : 0320003
Caba Ciudad De Buenos Aires, 1417, Argentina
Investigational Site Number : 0320008
Caba Ciudad De Buenos Aires, C1180, Argentina
Investigational Site Number : 0320005
Caba Ciudad De Buenos Aires, C1425, Argentina
Investigational Site Number : 0320010
Cordoba Córdoba, X5008, Argentina
Investigational Site Number : 0320004
Buenos Aires , 1426A, Argentina
Investigational Site Number : 0320009
Mendoza , M5501, Argentina
Investigational Site Number : 0360007
Liverpool New South Wales, 2170, Australia
Investigational Site Number : 0360004
Waratah New South Wales, 2298, Australia
Investigational Site Number : 0360003
Wollongong New South Wales, 2500, Australia
Investigational Site Number : 0360008
Adelaide South Australia, 5000, Australia
Investigational Site Number : 0360009
Fitzroy Victoria, 3065, Australia
Investigational Site Number : 0360006
Melbourne Victoria, 3004, Australia
Investigational Site Number : 0360001
Richmond Victoria, 3121, Australia
NOHC - Nucleo de Oncologia e Hematologia do Ceara Site Number : 0760006
Fortaleza Ceará, 60115, Brazil
OC ONCOCLINICAS MULTIHEMO ILHA DO LEITE Site Number : 0760007
Recife Pernambuco, 50070, Brazil
CHN - Complexo Hospitalar de Niteroi Site Number : 0760008
Niteroi Rio De Janeiro, 24020, Brazil
Hospital Mae de Deus Site Number : 0760003
Porto Alegre Rio Grande Do Sul, 90110, Brazil
A Beneficencia Portuguesa de Sao Paulo - Hospital Beneficencia Portuguesa - BP Mirante Site Number : 0760002
Sao Paulo São Paulo, 01321, Brazil
Clínica São Germano Site Number : 0760001
Sao Paulo São Paulo, 04537, Brazil
Instituto COI de Educacao e Pesquisa Site Number : 0760004
Rio De Janeiro , 22775, Brazil
Investigational Site Number : 1240001
Toronto Ontario, M5G 2, Canada
Investigational Site Number : 1240004
Greenfield Park Quebec, J4V 2, Canada
Investigational Site Number : 1240003
Montreal Quebec, H1T 2, Canada
Investigational Site Number : 1520002
Santiago Reg Metropolitana De Santiago, 75006, Chile
Investigational Site Number : 1520003
Santiago Reg Metropolitana De Santiago, 75009, Chile
Investigational Site Number : 1520006
Santiago Reg Metropolitana De Santiago, 76201, Chile
Investigational Site Number : 1520005
Viña del Mar Valparaíso, , Chile
Investigational Site Number : 1520004
Santiago , 83804, Chile
Investigational Site Number : 1520001
Temuco , 48008, Chile
Investigational Site Number : 1560001
Beijing , 10004, China
Investigational Site Number : 1560022
Beijing , 10019, China
Investigational Site Number : 1560010
Changsha , 41001, China
Investigational Site Number : 1560006
Guangzhou , 51006, China
Investigational Site Number : 1560002
Hangzhou , 31000, China
Investigational Site Number : 1560020
Nanchang , 33000, China
Investigational Site Number : 1560019
Nanning , 53000, China
Investigational Site Number : 1560011
Qingdao , 26601, China
Investigational Site Number : 1560017
Shanghai , 20009, China
Investigational Site Number : 1560013
Shenyang , 11002, China
Investigational Site Number : 1560021
Shenzhen , 51803, China
Investigational Site Number : 1560007
Tianjin , 30002, China
Investigational Site Number : 1560009
Tianjin , 30003, China
Investigational Site Number : 1560018
Tianjin , 30006, China
Investigational Site Number : 1560003
Wuhan , 43002, China
Investigational Site Number : 1560008
Wuhan , 43003, China
Investigational Site Number : 1560004
Zhengzhou , 45000, China
Investigational Site Number : 2030005
Brno , 62500, Czechia
Investigational Site Number : 2030003
Olomouc , 77900, Czechia
Investigational Site Number : 2030006
Ostrava - Poruba , 70852, Czechia
Investigational Site Number : 2030004
Praha 2 , 12808, Czechia
Investigational Site Number : 2500006
Lyon , 69373, France
Investigational Site Number : 2500002
Nantes , 44093, France
Investigational Site Number : 2500005
Paris , 75012, France
Investigational Site Number : 2500008
Perigueux , 24000, France
Investigational Site Number : 2500004
Pierre Benite , 69495, France
Investigational Site Number : 2500001
Poitiers , 86021, France
Investigational Site Number : 2500009
Saint-Etienne Cedex 2 , 42055, France
Investigational Site Number : 2500003
TOULOUSE Cedex 9 , 31059, France
Investigational Site Number : 2500007
Tours , 37044, France
Investigational Site Number : 2760005
Dresden , 01307, Germany
Investigational Site Number : 2760001
Hamburg , 22763, Germany
Investigational Site Number : 2760003
Heidelberg , 69120, Germany
Investigational Site Number : 2760006
Lübeck , 23538, Germany
Investigational Site Number : 2760007
Nürnberg , 90419, Germany
Investigational Site Number : 3000002
Athens , 10676, Greece
Investigational Site Number : 3000001
Athens , 11528, Greece
Investigational Site Number : 3000005
Ioannina , 45500, Greece
Investigational Site Number : 3000003
Patra , 26500, Greece
Investigational Site Number : 3000004
Thessaloniki , 57010, Greece
Investigational Site Number : 3480002
Budapest , 1083, Hungary
Investigational Site Number : 3480004
Budapest , 1097, Hungary
Investigational Site Number : 3480003
Kaposvár , 7400, Hungary
Investigational Site Number : 3480008
Pécs , 7624, Hungary
Investigational Site Number : 3480005
Szekesfehervar , 8000, Hungary
Investigational Site Number : 3480006
Szombathely , 9700, Hungary
Investigational Site Number : 3800001
Meldola Forlì-Cesena, 47014, Italy
Investigational Site Number : 3800004
Ancona , 60126, Italy
Investigational Site Number : 3800002
Bologna , 40138, Italy
Investigational Site Number : 3800005
Brescia , 25123, Italy
Investigational Site Number : 3800007
Napoli , 80131, Italy
Investigational Site Number : 3800008
Palermo , 90127, Italy
Investigational Site Number : 3800003
Pavia , 27100, Italy
Investigational Site Number : 3920001
Nagoya-shi Aichi, 467-8, Japan
Investigational Site Number : 3920007
Kamogawa-shi Chiba, 296-8, Japan
Investigational Site Number : 3920005
Higashiibaraki-gun Ibaraki, 311-3, Japan
Investigational Site Number : 3920010
Shiwa-gun Iwate, 028-3, Japan
Investigational Site Number : 3920012
Kamakura-shi Kanagawa, 247-0, Japan
Investigational Site Number : 3920003
Kyoto-shi Kyoto, 603-8, Japan
Investigational Site Number : 3920006
Natori-shi Miyagi, 981-1, Japan
Investigational Site Number : 3920002
Okayama-shi Okayama, 701-1, Japan
Investigational Site Number : 3920011
Osaka-shi Osaka, 530-8, Japan
Investigational Site Number : 3920008
Sunto-gun Shizuoka, 411-8, Japan
Investigational Site Number : 3920004
Shibuya-ku Tokyo, 150-8, Japan
Investigational Site Number : 3920009
Yamagata-shi , 990-9, Japan
Investigational Site Number : 5780001
Oslo , 0450, Norway
Investigational Site Number : 5780002
Ålesund , 6026, Norway
Investigational Site Number : 6160004
Wroclaw Dolnoslaskie, 50-36, Poland
Investigational Site Number : 6160005
Krakow Malopolskie, 30-68, Poland
Investigational Site Number : 6160001
Lublin , 20,08, Poland
Investigational Site Number : 6160003
Wroclaw , 53,43, Poland
Investigational Site Number : 7240003
Santander Cantabria, 39008, Spain
Investigational Site Number : 7240004
Badalona Catalunya [Cataluña], 08916, Spain
Investigational Site Number : 7240007
Madrid Madrid, Comunidad De, 28046, Spain
Investigational Site Number : 7240001
Pamplona Navarra, 31008, Spain
Investigational Site Number : 7240005
Madrid , 28034, Spain
Investigational Site Number : 7240006
Murcia , 30120, Spain
Investigational Site Number : 7240002
Salamanca , 37007, Spain
Investigational Site Number : 7520001
Borås , 50182, Sweden
Investigational Site Number : 7520002
Stockholm , 118 8, Sweden
Investigational Site Number : 7520003
Stockholm , 14186, Sweden
Investigational Site Number : 1580001
Kaohsiung , 83301, Taiwan
Investigational Site Number : 1580005
Tainan , 704, Taiwan
Investigational Site Number : 1580002
Taipei , 10002, Taiwan
Investigational Site Number : 7920007
Ankara , 06010, Turkey
Investigational Site Number : 7920009
Ankara , 06200, Turkey
Investigational Site Number : 7920004
Bornova , 35100, Turkey
Investigational Site Number : 7920003
Istanbul , 34093, Turkey
Investigational Site Number : 7920005
Istanbul , 34098, Turkey
Investigational Site Number : 7920008
Istanbul , 34214, Turkey
Investigational Site Number : 7920001
Istanbul , 34381, Turkey
Investigational Site Number : 8260002
Leicester Leicestershire, LE1 5, United Kingdom
Investigational Site Number : 8260005
London London, City Of, W12 0, United Kingdom
Investigational Site Number : 8260001
Norwich Norfolk, NR4 7, United Kingdom
Investigational Site Number : 8260004
Birmingham , B15 2, United Kingdom
Investigational Site Number : 8260003
Derby , DE223, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

534

Study ID:

NCT05405166

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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