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 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
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There are 77 Locations for this study
Jacksonville Florida, 32224, United States
Hattiesburg Mississippi, 39401, United States
Salt Lake City Utah, 84148, United States
Waukesha Wisconsin, 53188, United States
Caba Buenos Aires, 1280, Argentina
Caba Buenos Aires, 1430, Argentina
Caba Buenos Aires, C1181, Argentina
La Plata Buenos Aires, 1900, Argentina
Caba Ciudad De Buenos Aires, C1425, Argentina
Buenos Aires , 1426A, Argentina
Liverpool New South Wales, 2170, Australia
Waratah New South Wales, 2298, Australia
Wollongong New South Wales, 2500, Australia
Adelaide South Australia, 5000, Australia
Melbourne Victoria, 3004, Australia
Richmond Victoria, 3121, Australia
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
Viña del Mar ValparaÃso, , Chile
Santiago , 83804, Chile
Temuco , 48008, Chile
Beijing , 10004, 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
Tianjin , 30002, China
Tianjin , 30003, China
Tianjin , 30006, China
Wuhan , 43002, China
Wuhan , 43003, China
Zhengzhou , 45000, China
Ostrava - Poruba , 70852, Czechia
Praha 2 , 12808, Czechia
Nantes , 44093, France
Paris , 75012, France
Pierre Benite , 69495, France
Poitiers , 86021, France
Tours , 37044, France
Athens , 10676, Greece
Athens , 11528, Greece
Ioannina , 45500, Greece
Budapest , 1097, Hungary
Kaposvár , 7400, Hungary
Pécs , 7624, Hungary
Szekesfehervar , 8000, Hungary
Szombathely , 9700, Hungary
Meldola Forlì-Cesena, 47014, Italy
Ancona , 60020, Italy
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
Krakow Malopolskie, 31-50, Poland
Lublin , 20,08, Poland
Santander Cantabria, 39008, Spain
Badalona Catalunya [Cataluña], 08916, Spain
Pamplona Navarra, 31008, Spain
Madrid , 28034, Spain
Salamanca , 37007, Spain
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