International treatment-extension study in adult participants with multiple myeloma and who have derived clinical benefit from isatuximab

JRCT ID: jRCT2031230009

Registered date:07/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Plasma cell myeloma
• Date of first enrollment: 17/05/2023
• Target sample size: 70
• Countries of recruitment: Finland,Japan,Czech Republic,Japan,Sweden,Japan,Australia,Japan,Brazil,Japan,Chile,Japan,China,Japan,France,Japan,Greece,Japan,Republic of Korea,Japan,Russian Federation,Japan,Spain,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Isatuximab IV (SAR650984)
Pharmaceutical form: Vial Route of administration: IV infusion
Drug: Dexamethasone
Pharmaceutical form: Tablets Route of administration: Oral
Drug: Pomalidomide
Pharmaceutical form: Hard capsules Route of administration: Oral
Drug: Cemiplimab (SAR439684)
Pharmaceutical form: Vial Route of administration: IV infusion
Drug: Lenalidomide
Pharmaceutical form: Capsules Route of administration: Oral
Drug: Isatuximab SC (SAR650984)
Pharmaceutical form: Vial, Route of administration: SC injection with the investigational isatuximab injector device

Note: In Japan, only Isatuximab, Pomalidomide and Dexamethasone, which were used in previous studies, are used.

Outcome(s)

Primary Outcome

Number of participants with treatment-emergent adverse events
[Time Frame baseline:Baseline to 42 months]

• Secondary Outcome: Not applicable

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

Participants are excluded from the study if any of the following criteria apply:
- Participant has evidence of progressive disease during or at the time of the parental study closure.
- 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.
- 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.

Related Information

• Primary Sponsor: Tanaka Tomoyuki
• Secondary ID(s): NCT05669989,2022-002253-26