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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05669989




Registration number
NCT05669989
Ethics application status
Date submitted
20/12/2022
Date registered
3/01/2023

Titles & IDs
Public title
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
Scientific title
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
Secondary ID [1] 0 0
U1111-1277-6635
Secondary ID [2] 0 0
LTS17704
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasma Cell Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Isatuximab intravenous (IV)
Treatment: Drugs - Cemiplimab (SAR439684)
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Isatuximab subcutaneous (SC)
Treatment: Drugs - Carfilzomib

Experimental: Isatuximab - Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol


Treatment: Drugs: Isatuximab intravenous (IV)
Route of administration: IV infusion; Pharmaceutical form: Vial

Treatment: Drugs: Cemiplimab (SAR439684)
Route of administration: IV infusion; Pharmaceutical form: Vial

Treatment: Drugs: Dexamethasone
Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial

Treatment: Drugs: Lenalidomide
Route of administration: Oral; Pharmaceutical form: Capsules

Treatment: Drugs: Pomalidomide
Route of administration: Oral; Pharmaceutical form: Hard capsules

Treatment: Drugs: Isatuximab subcutaneous (SC)
Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial

Treatment: Drugs: Carfilzomib
Route of administration: IV infusion; Pharmaceutical form: Vial
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent adverse events
Timepoint [1] 0 0
Baseline to 42 months

Eligibility
Key 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 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360006 - Blacktown
Recruitment hospital [2] 0 0
Investigational Site Number : 0360001 - Saint Leonards
Recruitment hospital [3] 0 0
Investigational Site Number : 0360003 - Wollongong
Recruitment hospital [4] 0 0
Investigational Site Number : 0360004 - Melbourne
Recruitment hospital [5] 0 0
Investigational Site Number : 0360005 - Melbourne
Recruitment hospital [6] 0 0
Investigational Site Number : 0360002 - Richmond
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
3065 - Melbourne
Recruitment postcode(s) [5] 0 0
3084 - Melbourne
Recruitment postcode(s) [6] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
Brazil
State/province [2] 0 0
Rio de Janeiro
Country [3] 0 0
Chile
State/province [3] 0 0
Temuco
Country [4] 0 0
China
State/province [4] 0 0
Tianjin
Country [5] 0 0
Czechia
State/province [5] 0 0
Brno
Country [6] 0 0
Czechia
State/province [6] 0 0
Ostrava
Country [7] 0 0
Czechia
State/province [7] 0 0
Prague
Country [8] 0 0
Finland
State/province [8] 0 0
Helsinki
Country [9] 0 0
France
State/province [9] 0 0
Nantes
Country [10] 0 0
Greece
State/province [10] 0 0
Athens
Country [11] 0 0
Greece
State/province [11] 0 0
Patras
Country [12] 0 0
Italy
State/province [12] 0 0
Torino
Country [13] 0 0
Japan
State/province [13] 0 0
Okayama
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul-teukbyeolsi
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
New Zealand
State/province [16] 0 0
Newtown, Wellington
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Kirov
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Moscow
Country [19] 0 0
Spain
State/province [19] 0 0
Andalucia
Country [20] 0 0
Spain
State/province [20] 0 0
Cantabria
Country [21] 0 0
Spain
State/province [21] 0 0
Catalunya [Cataluña]
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid, Comunidad De
Country [23] 0 0
Spain
State/province [23] 0 0
Navarra
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Spain
State/province [25] 0 0
Salamanca
Country [26] 0 0
Sweden
State/province [26] 0 0
Luleå
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05669989