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About
The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.
Full description
The duration of the study for a participant will include a period for screening of up to 28 days, a study treatment period of 12 months (except early discontinuation), the end-of-treatment (EOT) visit about 30 days after the last dose of study treatment, and a study follow-up period until death or the final study cut-off date. A cycle duration is 28 days. After study treatment discontinuation, participants will return to the study site 30 days after the last dose of study treatment for the EOT visit or before further anti-myeloma therapy initiation, whichever comes first.
Enrollment
Sex
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Volunteers
Inclusion criteria
Participants must have a documented diagnosis of MM.
Participants with measurable disease defined as at least one of the following:
Participants with relapsed and/or refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy.
Contraceptive use by [men and women] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Capable of giving signed informed consent.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
64 participants in 1 patient group
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Central trial contact
Trial Transparency email recommended (Toll free for US & Canada)
Data sourced from clinicaltrials.gov
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