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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05669989
Registration number
NCT05669989
Ethics application status
Date submitted
20/12/2022
Date registered
3/01/2023
Date last updated
15/02/2024
Titles & IDs
Public title
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
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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
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Secondary ID [1]
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U1111-1277-6635
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Secondary ID [2]
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LTS17704
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Plasma Cell Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Isatuximab IV (SAR650984)
Treatment: Drugs - Cemiplimab (SAR439684)
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Isatuximab SC (SAR650984)
Experimental: Isatuximab - Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the patient received on the parental protocol
Treatment: Drugs: Isatuximab IV (SAR650984)
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 Pharmaceutical form: Tablets
Treatment: Drugs: Lenalidomide
Route of administration: Oral Pharmaceutical form: Capsules
Treatment: Drugs: Pomalidomide
Route of administration: Oral Pharmaceutical form: Hard capsules
Treatment: Drugs: Isatuximab SC (SAR650984)
Route of administration: SC injection with the investigational isatuximab injector device Pharmaceutical form: Vial
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with treatment-emergent adverse events
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Assessment method [1]
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Timepoint [1]
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Baseline to 42 months
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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 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
21/09/2026
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Actual
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Sample size
Target
70
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360001 - St Leonards
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Recruitment hospital [2]
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Investigational Site Number : 0360003 - Wollongong
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Recruitment hospital [3]
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Investigational Site Number : 0360004 - Fitzroy
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Recruitment hospital [4]
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Investigational Site Number : 0360002 - Richmond
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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3065 - Fitzroy
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Recruitment postcode(s) [4]
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3121 - Richmond
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Missouri
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Country [2]
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Brazil
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State/province [2]
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Rio De Janeiro
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Country [3]
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Chile
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State/province [3]
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Temuco
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Country [4]
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China
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State/province [4]
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Tianjin
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Country [5]
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Czechia
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State/province [5]
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Praha 2
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Country [6]
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Finland
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State/province [6]
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Helsinki
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Country [7]
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France
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State/province [7]
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Nantes
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Country [8]
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Greece
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State/province [8]
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Patra
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Country [9]
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Italy
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State/province [9]
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Torino
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Country [10]
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Japan
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State/province [10]
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Okayama
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Country [11]
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Korea, Republic of
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State/province [11]
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Seoul-teukbyeolsi
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Country [12]
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Russian Federation
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State/province [12]
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Moscow
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Country [13]
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Spain
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State/province [13]
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Cantabria
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Country [14]
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Spain
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State/province [14]
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Madrid, Comunidad De
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Country [15]
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Spain
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State/province [15]
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Navarra
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Country [16]
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Spain
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State/province [16]
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Madrid
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Country [17]
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Spain
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State/province [17]
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Salamanca
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Country [18]
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Sweden
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State/province [18]
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Luleå
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Country [19]
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Taiwan
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State/province [19]
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Taichung
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
- This is a multi-center, open-label, Phase 2 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.
- This Treatment Extension study has the purpose to provide continued access to
isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab
parental study for which study objectives are completed will be eligible to be enrolled
in this Treatment Extension study.
- The primary objective of the study is to assess long-term safety of isatuximab as study
treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05669989
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Trial Transparency email recommended (Toll free for US & Canada)
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Address
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Country
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05669989
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