Trial Title:
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
NCT ID:
NCT05669989
Condition:
Plasma Cell Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Lenalidomide
Pomalidomide
Cemiplimab
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Isatuximab intravenous (IV)
Description:
Route of administration: IV infusion; Pharmaceutical form: Vial
Arm group label:
Isatuximab
Other name:
SARCLISA®, SAR650984
Intervention type:
Drug
Intervention name:
Cemiplimab (SAR439684)
Description:
Route of administration: IV infusion; Pharmaceutical form: Vial
Arm group label:
Isatuximab
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use
vial
Arm group label:
Isatuximab
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Route of administration: Oral; Pharmaceutical form: Capsules
Arm group label:
Isatuximab
Intervention type:
Drug
Intervention name:
Pomalidomide
Description:
Route of administration: Oral; Pharmaceutical form: Hard capsules
Arm group label:
Isatuximab
Intervention type:
Drug
Intervention name:
Isatuximab subcutaneous (SC)
Description:
Route of administration: SC injection with the investigational isatuximab injector
device; Pharmaceutical form: Vial
Arm group label:
Isatuximab
Other name:
SARCLISA®, SAR650984
Intervention type:
Drug
Intervention name:
Carfilzomib
Description:
Route of administration: IV infusion; Pharmaceutical form: Vial
Arm group label:
Isatuximab
Summary:
- This is a multi-center, open-label, Phase 2 treatment extension study in
participants 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.
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.
Criteria for eligibility:
Criteria:
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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine- Site Number : 8400001
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 0360006
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 0360001
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 0360003
Address:
City:
Wollongong
Zip:
2500
Country:
Australia
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 0360004
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 0360005
Address:
City:
Heidelberg West
Zip:
3081
Country:
Australia
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 0360002
Address:
City:
Richmond
Zip:
3121
Country:
Australia
Status:
Active, not recruiting
Facility:
Name:
Instituto COI de Educacao e Pesquisa- Site Number : 0760001
Address:
City:
Rio De Janeiro
Zip:
22775-002
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 1520001
Address:
City:
Temuco
Zip:
4800827
Country:
Chile
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 1560001
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 2030002
Address:
City:
Brno
Zip:
62500
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 2030003
Address:
City:
Ostrava - Poruba
Zip:
70852
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 2030001
Address:
City:
Praha 2
Zip:
12808
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 2460001
Address:
City:
Helsinki
Zip:
00029
Country:
Finland
Status:
Completed
Facility:
Name:
Investigational Site Number : 2500002
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 3000004
Address:
City:
Athens
Zip:
10676
Country:
Greece
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 3000003
Address:
City:
Athens
Zip:
11528
Country:
Greece
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 3000001
Address:
City:
Patra
Zip:
26504
Country:
Greece
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 3800002
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 3920001
Address:
City:
Okayama-shi
Zip:
701-1192
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 4100001
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 4100002
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 6430002
Address:
City:
Kirov
Zip:
610027
Country:
Russian Federation
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 6430001
Address:
City:
Moscow
Zip:
125284
Country:
Russian Federation
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 7240004
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 7241001
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 7240001
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 7240003
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 7240002
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Investigational Site Number : 7520004
Address:
City:
Luleå
Zip:
97180
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 1580001
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Completed
Start date:
April 5, 2023
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Sanofi
Agency class:
Industry
Source:
Sanofi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05669989
