BridgeMD
International treatment-extension study in adult participants with multiple myeloma and who have derived clinical benefit from isatuximab
EU CTIS ID: 2023-507180-19-00
What this study is testing
To assess the long-term safety of isatuximab administered as monotherapy or in combination regimens in participants previously treated with isatuximab
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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.
You likely can't join if
- - 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
See the full eligibility 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 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.
- - 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Australia
- Russian Federation
- United States
- New Zealand
- Taiwan
- Korea, Republic of
- Brazil
- Japan
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Australia; Russian Federation; United States; New Zealand; Taiwan and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.