Last updated 29 days ago
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
531 patients around the world
Available in Chile, Argentina
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.
Sanofi
8Research sites
531Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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)).
- Primary refractory multiple myeloma participantsParticipants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously receivedPrior therapy with pomalidomideParticipants with inadequate biological tests.Significant cardiac dysfunctionParticipants 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 therapyConcomitant plasma cell leukemiaActive primary amyloid light -chain amyloidosisKnown acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatmentKnow 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
Sites
Fundación Sanatorio Güemes - CABA, Buenos Aires
Recruiting
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Arbesú Hematología
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Hospital Italiano de La Plata
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
StudyIRAKLIA
SponsorSanofi
Study typeInterventional
Conditions
Multiple myeloma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05405166
