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.

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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 therapy including lenalidomide and a proteasome inhibitor, and with 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:

Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2
Primary refractory multiple myeloma participants
Participants refractory to anti-CD38 with a wash-out period inferior to 9 months or intolerant to anti-CD38 mAb agents
Prior therapy with pomalidomide
Participants with inadequate biological tests.
Significant cardiac dysfunction
Participants diagnosed or treated for another cancer 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 (AL) 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 77 Locations for this study

See Locations Near You

Mayo Clinic-Site Number:8400008
Jacksonville Florida, 32224, United States
Hattiesburg Clinic-Site Number:8400006
Hattiesburg Mississippi, 39401, 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
Caba Buenos Aires, C1181, Argentina
Investigational Site Number :0320006
La Plata Buenos Aires, 1900, Argentina
Investigational Site Number :0320005
Caba Ciudad De Buenos Aires, C1425, Argentina
Investigational Site Number :0320004
Buenos Aires , 1426A, 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 :0360006
Melbourne Victoria, 3004, Australia
Investigational Site Number :0360001
Richmond Victoria, 3121, Australia
Investigational Site Number :0760003
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Investigational Site Number :0760002
Sao Paulo São Paulo, 01321, Brazil
Investigational Site Number :0760001
Sao Paulo São Paulo, 04537, Brazil
Investigational 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 :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 :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 :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 :2030006
Ostrava - Poruba , 70852, Czechia
Investigational Site Number :2030004
Praha 2 , 12808, Czechia
Investigational Site Number :2500002
Nantes , 44093, France
Investigational Site Number :2500005
Paris , 75012, France
Investigational Site Number :2500004
Pierre Benite , 69495, France
Investigational Site Number :2500001
Poitiers , 86021, France
Investigational Site Number :2500007
Tours , 37044, France
Investigational Site Number :3000002
Athens , 10676, Greece
Investigational Site Number :3000001
Athens , 11528, Greece
Investigational Site Number :3000005
Ioannina , 45500, Greece
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 , 60020, Italy
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 :6160005
Krakow Malopolskie, 31-50, Poland
Investigational Site Number :6160001
Lublin , 20,08, Poland
Investigational Site Number :7240003
Santander Cantabria, 39008, Spain
Investigational Site Number :7240004
Badalona Catalunya [Cataluña], 08916, Spain
Investigational Site Number :7240001
Pamplona Navarra, 31008, Spain
Investigational Site Number :7240005
Madrid , 28034, Spain
Investigational Site Number :7240002
Salamanca , 37007, Spain

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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