JRCT ID: jRCT2031230009
Registered date:07/04/2023
International treatment-extension study in adult participants with multiple myeloma and who have derived clinical benefit from isatuximab
Basic Information
Recruitment status | Recruiting |
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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] |
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Secondary Outcome | Not applicable |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05669989,2022-002253-26 |
Contact
Public contact | |
Name | Unit Study Clinical |
Address | Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan Tokyo Japan 163-1488 |
Telephone | +81-3-6301-3670 |
clinical-trials-jp@sanofi.com | |
Affiliation | Sanofi K.K. |
Scientific contact | |
Name | Tomoyuki Tanaka |
Address | Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan Tokyo Japan 163-1488 |
Telephone | +81-3-6301-3670 |
clinical-trials-jp@sanofi.com | |
Affiliation | Sanofi K.K. |