None listed
Conditions
Interventions
1-ISA arm (Isatuximab): Isatuximab will be administered by IV infusion. The appropriate volume of Isatuximab will be diluted in an infusion bag of 0.9% sodium chloride solution and will be administere
75 year-old: 20 mg/day. The days of Isatuximab infusion the administration of dexamethasone will follow the premedication rules.
Sponsors
Sanofi Aventis Recherche & Development,
Eligibility
Inclusion criteria
Inclusion criteria: 1-Diagnosis of multiple myeloma with evidence of measurable disease, and have evidence of disease progression based on International Myeloma Working Group criteria (IMWG) 2-Patients must have received prior treatment with an IMiD (for ≥2 cycles or ≥2 months of treatment) and a proteasome inhibitor (for ≥2 cycles or ≥2 months of treatment) 3-Have received at least three prior lines of therapy (Appendix C of protocol) for multiple myeloma. Induction therapy and stem cell transplant (± maintenance) will be considered as one line OR Patients whose disease is double refractory to an IMID and a PI. For patients who have received more than one type of IMiD and PI, their disease must be refractory to the most recent one. Refractory disease is defined as a disease that is progressive while being on treatment, or progressive within 60 days of the last administration of these therapies or never reached at least a MR with those drugs 4-Patients must have achieved an MR or better to at least one prior line of therapy 5-Patients must have received an alkylating agent (for ≥2 cycles or ≥2 months of treatment) either alone or in combination with other MM treatments (history of stem cell transplant is acceptable). 6-Signed written informed consent and be willing and able to complete all studyrelated procedures
Exclusion criteria
Exclusion criteria: 1-Be 2 11-Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results. 12-Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the investigator, could interfere with the safety, the compliance with the study or with the interpretation of the results. 13-Known intolerance to infused protein products, sucrose, histidine, polysorbate 80 or known hypersensitivity to any of the components of study therapy that is not amenable to pre-medication with steroids and H2 blockers
Countries
Argentina, Austria, Belgium, Brazil, Chile, Colombia, Finland, Greece, Israel, Italy, Mexico, Russian Federation, Spain, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactVanesa Rios
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed