Multiple myeloma MedDRA version: 21.1 Level: PT Classification code 10035226 Term: Plasma cell myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be =18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent. - Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximab monotherapy or in a combination regimen with all the study objectives completed. - Participants still receiving isatuximab at the time of the parental study closure, who are continuing to benefit from isatuximab as monotherapy or in combination, as determined by the treating physician, and who meet the criteria to initiate a subsequent cycle of therapy as described in the parental study protocol. A patient not receiving isatuximab at the end of the parental study who does not have access locally to the ongoing treatment may also be included. - Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants. - Capable of giving signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42
Exclusion criteria
Exclusion criteria: - Participant has evidence of progressive disease during or at the time of the parental study closure. - Participant has not recovered to =Grade 2 from non hematologic AEs (as per NCI CTCAE v5.0) related to any anticancer therapy received prior to signing informed consent on the extension study. - As the latest line of treatment participant received an antimyeloma therapy other than the isatuximab-based therapy in the parental study before the first IMP in this study. - Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. - Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. - Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals. - Any country-related specific regulation that would prevent the participant from entering the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety of isatuximab administered as monotherapy or in combination regimens in patients previously treated with isatuximab;Secondary Objective: Not applicable;Primary end point(s): Number of participants with treatment-emergent adverse events;Timepoint(s) of evaluation of this end point: Baseline to 42 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Australia, Brazil, Chile, China, Czechia, Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Republic of, Russian Federation, Spain, Sweden, Taiwan, Turkey, United Kingdom
Contacts
Public ContactDirection des Opérations Cliniques
Sanofi-Aventis France
Outcome results
None listed