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.
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.
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.
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There are 150 Locations for this study
Bullhead City Arizona, 86442, United States
Prescott Valley Arizona, 86314, United States
Aurora Colorado, 80012, United States
Jacksonville Florida, 32224, United States
Plantation Florida, 33322, United States
Bethesda Maryland, 20817, United States
Hattiesburg Mississippi, 39401, United States
Las Vegas Nevada, 89169, United States
Morristown New Jersey, 07960, United States
Albany New York, 12206, United States
Charlotte North Carolina, 28207, United States
Winston-Salem North Carolina, 27103, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45236, United States
Eugene Oregon, 97401, United States
Easton Pennsylvania, 18045, United States
Spartanburg South Carolina, 29303, United States
Dallas Texas, 75246, United States
Kingwood Texas, 77339, United States
San Antonio Texas, 78240, United States
Salt Lake City Utah, 84148, United States
Waukesha Wisconsin, 53188, United States
Caba Buenos Aires, 1280, Argentina
Caba Buenos Aires, 1430, Argentina
Ciudad Autonoma de Buenos Aires Buenos Aires, C1181, Argentina
La Plata Buenos Aires, 1900, Argentina
Caba Ciudad De Buenos Aires, 1417, Argentina
Caba Ciudad De Buenos Aires, C1180, Argentina
Caba Ciudad De Buenos Aires, C1425, Argentina
Cordoba Córdoba, X5008, Argentina
Buenos Aires , 1426A, Argentina
Mendoza , M5501, Argentina
Liverpool New South Wales, 2170, Australia
Waratah New South Wales, 2298, Australia
Wollongong New South Wales, 2500, Australia
Adelaide South Australia, 5000, Australia
Fitzroy Victoria, 3065, Australia
Melbourne Victoria, 3004, Australia
Richmond Victoria, 3121, Australia
Fortaleza Ceará, 60115, Brazil
Recife Pernambuco, 50070, Brazil
Niteroi Rio De Janeiro, 24020, Brazil
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Sao Paulo São Paulo, 01321, Brazil
Sao Paulo São Paulo, 04537, Brazil
Rio De Janeiro , 22775, Brazil
Toronto Ontario, M5G 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H1T 2, Canada
Santiago Reg Metropolitana De Santiago, 75006, Chile
Santiago Reg Metropolitana De Santiago, 75009, Chile
Santiago Reg Metropolitana De Santiago, 76201, Chile
Viña del Mar Valparaíso, , Chile
Santiago , 83804, Chile
Temuco , 48008, Chile
Beijing , 10004, China
Beijing , 10019, China
Changsha , 41001, China
Guangzhou , 51006, China
Hangzhou , 31000, China
Nanchang , 33000, China
Nanning , 53000, China
Qingdao , 26601, China
Shanghai , 20009, China
Shenyang , 11002, China
Shenzhen , 51803, China
Tianjin , 30002, China
Tianjin , 30003, China
Tianjin , 30006, China
Wuhan , 43002, China
Wuhan , 43003, China
Zhengzhou , 45000, China
Brno , 62500, Czechia
Olomouc , 77900, Czechia
Ostrava - Poruba , 70852, Czechia
Praha 2 , 12808, Czechia
Lyon , 69373, France
Nantes , 44093, France
Paris , 75012, France
Perigueux , 24000, France
Pierre Benite , 69495, France
Poitiers , 86021, France
Saint-Etienne Cedex 2 , 42055, France
TOULOUSE Cedex 9 , 31059, France
Tours , 37044, France
Dresden , 01307, Germany
Hamburg , 22763, Germany
Heidelberg , 69120, Germany
Lübeck , 23538, Germany
Nürnberg , 90419, Germany
Athens , 10676, Greece
Athens , 11528, Greece
Ioannina , 45500, Greece
Patra , 26500, Greece
Thessaloniki , 57010, Greece
Budapest , 1083, Hungary
Budapest , 1097, Hungary
Kaposvár , 7400, Hungary
Pécs , 7624, Hungary
Szekesfehervar , 8000, Hungary
Szombathely , 9700, Hungary
Meldola Forlì-Cesena, 47014, Italy
Ancona , 60126, Italy
Bologna , 40138, Italy
Brescia , 25123, Italy
Napoli , 80131, Italy
Palermo , 90127, Italy
Pavia , 27100, Italy
Nagoya-shi Aichi, 467-8, Japan
Kamogawa-shi Chiba, 296-8, Japan
Higashiibaraki-gun Ibaraki, 311-3, Japan
Shiwa-gun Iwate, 028-3, Japan
Kamakura-shi Kanagawa, 247-0, Japan
Kyoto-shi Kyoto, 603-8, Japan
Natori-shi Miyagi, 981-1, Japan
Okayama-shi Okayama, 701-1, Japan
Osaka-shi Osaka, 530-8, Japan
Sunto-gun Shizuoka, 411-8, Japan
Shibuya-ku Tokyo, 150-8, Japan
Yamagata-shi , 990-9, Japan
Oslo , 0450, Norway
Ålesund , 6026, Norway
Wroclaw Dolnoslaskie, 50-36, Poland
Krakow Malopolskie, 30-68, Poland
Lublin , 20,08, Poland
Wroclaw , 53,43, Poland
Santander Cantabria, 39008, Spain
Badalona Catalunya [Cataluña], 08916, Spain
Madrid Madrid, Comunidad De, 28046, Spain
Pamplona Navarra, 31008, Spain
Madrid , 28034, Spain
Murcia , 30120, Spain
Salamanca , 37007, Spain
Borås , 50182, Sweden
Stockholm , 118 8, Sweden
Stockholm , 14186, Sweden
Kaohsiung , 83301, Taiwan
Tainan , 704, Taiwan
Taipei , 10002, Taiwan
Ankara , 06010, Turkey
Ankara , 06200, Turkey
Bornova , 35100, Turkey
Istanbul , 34093, Turkey
Istanbul , 34098, Turkey
Istanbul , 34214, Turkey
Istanbul , 34381, Turkey
Leicester Leicestershire, LE1 5, United Kingdom
London London, City Of, W12 0, United Kingdom
Norwich Norfolk, NR4 7, United Kingdom
Birmingham , B15 2, United Kingdom
Derby , DE223, United Kingdom
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