JOURNAL ONKOLOGIE – STUDIE

International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

Studienbeginn:
April 2023

Letztes Update:
15.02.2024

Wirkstoff:
Isatuximab IV (SAR650984), Cemiplimab (SAR439684), Dexamethasone, Lenalidomide, Pomalidomide, Isatuximab SC (SAR650984)

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Sanofi

Collaborator:
-

Studienleiter

Clinical Sciences & Operations
Study Director
Sanofi

Kontakt

Trial Transparency email recommended (Toll free for US & Canada)
Kontakt:
Phone: 800-633-1610
Phone (ext.): option 6
E-Mail: Contact-US@sanofi.com» Kontaktdaten anzeigen

Studienlocations
(3 von 23)

Washington University School of Medicine Site Number : 8400001
63110 Saint Louis
United StatesRekrutierend» Google-Maps

Investigational Site Number : 0360001
2065 St Leonards
AustraliaRekrutierend» Google-Maps

Investigational Site Number : 0360003
2500 Wollongong
AustraliaRekrutierend» Google-Maps

Investigational Site Number : 0360004
3065 Fitzroy
AustraliaRekrutierend» Google-Maps

Investigational Site Number : 0360002
3121 Richmond
AustraliaRekrutierend» Google-Maps

Instituto COI de Educacao e Pesquisa Site Number : 0760001
22775-002 Rio De Janeiro
BrazilRekrutierend» Google-Maps

Investigational Site Number : 1520001
4800827 Temuco
ChileRekrutierend» Google-Maps

Investigational Site Number : 1560001
300020 Tianjin
ChinaRekrutierend» Google-Maps

Investigational Site Number : 2030001
12808 Praha 2
CzechiaRekrutierend» Google-Maps

Investigational Site Number : 2460001
00029 Helsinki
FinlandRekrutierend» Google-Maps

Investigational Site Number : 2500002
44093 Nantes
FranceRekrutierend» Google-Maps

Investigational Site Number : 3000001
26504 Patra
GreeceRekrutierend» Google-Maps

Investigational Site Number : 3800002
10126 Torino
ItalyRekrutierend» Google-Maps

Investigational Site Number : 3920001
701-1192 Okayama-shi
JapanRekrutierend» Google-Maps

Investigational Site Number : 4100001
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Investigational Site Number : 6430001
125284 Moscow
Russian FederationRekrutierend» Google-Maps

Investigational Site Number : 7240004
39008 Santander
SpainRekrutierend» Google-Maps

Investigational Site Number : 7241001
28027 Madrid
SpainRekrutierend» Google-Maps

Investigational Site Number : 7240001
31008 Pamplona
SpainRekrutierend» Google-Maps

Investigational Site Number : 7240003
28041 Madrid
SpainRekrutierend» Google-Maps

Investigational Site Number : 7240002
37007 Salamanca
SpainRekrutierend» Google-Maps

Investigational Site Number : 7520004
97180 Luleå
SwedenRekrutierend» Google-Maps

Investigational Site Number : 1580001
40447 Taichung
TaiwanRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Detailed Description:

Participants can continue the treatment until disease progression, unacceptable adverse

events, participant wish to discontinue study treatment, study treatment is commercially

available and reimbursed in participant's country, or for any other reason, whichever comes

first. The overall study duration will be of approximately 42 months.

Ein-/Ausschlusskriterien

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.

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 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.

The above information is not intended to contain all considerations relevant to a potential

participation in a clinical trial.

Studien-Rationale

Primary outcome:

1. Number of participants with treatment-emergent adverse events (Time Frame - Baseline to 42 months)

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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