Continued isatuximab access for adults with multiple myeloma who benefited from earlier study
Continues isatuximab treatment for adults with multiple myeloma from a previous study.
Plain-language title generated from the registry record
Registry title: International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
Key facts
- Where
- Blacktown, Heidelberg, Melbourne, Richmond, Saint Leonards, and Wollongong, AustraliaSee the 6 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple myeloma who are still benefiting from isatuximab after finishing an earlier Phase 1, 2 or 3 study. It gives them continued access to the treatment.
- Age
- 18 years or older (or the legal age of consent where the study takes place)
- Sex
- All sexes can join.
- Disease stage
- Multiple myeloma with no sign of progressive disease at the end of the earlier study.
- Earlier treatment
- Must have taken part in an earlier Phase 1, 2 or 3 study of isatuximab (alone or with other drugs) whose objectives are completed. Must still be benefiting from isatuximab, as judged by the treating doctor. Must not have had a different myeloma treatment as the latest treatment.
Main reasons for not taking part
- Signs of progressive disease during or at the end of the earlier study
- Side effects from earlier cancer treatment not yet recovered to Grade 2 or milder
- Latest treatment was a myeloma therapy other than isatuximab-based therapy from the earlier study
- Pregnant or breastfeeding
- Living in an institution because of a legal or regulatory order, or being a prisoner
Read by machine on 12 November 2026.
Where in Australia
- Blacktown, New South WalesHospital not named in the registryNo longer taking part
- Heidelberg, VictoriaHospital not named in the registryNo longer taking part
- Melbourne, VictoriaHospital not named in the registryNo longer taking part
- Richmond, VictoriaHospital not named in the registryNo longer taking part
- Saint Leonards, New South WalesHospital not named in the registryNo longer taking part
- Wollongong, New South WalesHospital not named in the registryNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sanofi
- Trial code
- NCT05669989
- Record updated
- 15 October 2026
- Original description
* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. * The primary objective of the study is to assess long-term safety of isatuximab as study treatment.Read full original descriptionShow less
International, Multi-center, Open-label, Treatment Extension Study in Patients With Multiple Myeloma Who Are Still Benefitting From Isatuximab-based Therapy Following Completion of a Phase 1, 2, or 3 Parental Study
* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. * The primary objective of the study is to assess long-term safety of isatuximab as study treatment.
Inclusion: 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 participant 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.
Exclusion: Participant has not recovered to ≤Grade 2 from nonhematologic 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; Participant has evidence of progressive disease during or at the time of the parental study closure; 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; Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized; 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; The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.