Plasma Cell MyelomaPhase 2NCT05669989
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
A Phase 2 study testing Isatuximab intravenous (IV), Cemiplimab (SAR439684) and Dexamethasone in people with Plasma Cell Myeloma, run by Sanofi at 37 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- Isatuximab intravenous (IV), Cemiplimab (SAR439684) and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 37 sitesin 17 countries
- Study dates
- 5 Apr 2023to 30 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
37 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 17 countries
Spain7 sites
Investigational Site Number : 7240005
Badalona, Barcelona [Barcelona], 08916
Investigational Site Number : 7241001
Madrid, 28027
Investigational Site Number : 7240003
Madrid, 28041
Investigational Site Number : 7240001
Pamplona, Navarre, 31008
Investigational Site Number : 7240002
Salamanca, Castille and León, 37007
Investigational Site Number : 7240004
Santander, Cantabria, 39008
Investigational Site Number : 7240006
Seville, Andalusia, 41013
Australia6 sites
Investigational Site Number : 0360006
Blacktown, New South Wales, 2148
Investigational Site Number : 0360005
Heidelberg, Victoria, 3084
Investigational Site Number : 0360004
Melbourne, Victoria, 3065
Investigational Site Number : 0360002
Richmond, Victoria, 3121
Investigational Site Number : 0360001
Saint Leonards, New South Wales, 2065
Investigational Site Number : 0360003
Wollongong, New South Wales, 2500
Brazil3 sites
Hospital Mae de Deus- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, 90880-480
Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760001
Rio de Janeiro, 22775-001
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760002
São Paulo, 05403-000
Czechia3 sites
Investigational Site Number : 2030002
Brno, 625 00
Investigational Site Number : 2030003
Ostrava, 708 52
Investigational Site Number : 2030001
Prague, 128 08
Greece3 sites
Investigational Site Number : 3000004
Athens, 106 76
Investigational Site Number : 3000003
Athens, 115 28
Investigational Site Number : 3000001
Pátrai, 265 04
New Zealand2 sites
Investigational Site Number : 5540002
Auckland, 2025
Investigational Site Number : 5540001
Wellington, 6021
Russia2 sites
Investigational Site Number : 6430002
Kirov, 610027
Investigational Site Number : 6430001
Moscow, 125284
South Korea2 sites
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, 03080
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 06591
United States1 site
Washington University- Site Number : 8400001
St Louis, Missouri, 63110
Japan1 site
Investigational Site Number : 3920001
Okayama, Okayama-ken, 701-1192
About this study
Official 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
- 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.
Read the 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.
- Conditions
- Plasma Cell Myeloma
- Being tested
- Isatuximab intravenous (IV), Cemiplimab (SAR439684), Dexamethasone, Lenalidomide, Pomalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isatuximab intravenous (IV)Drug
Also called SARCLISA®, SAR650984
Route of administration: IV infusion; Pharmaceutical form: Vial
Cemiplimab (SAR439684)Drug
Route of administration: IV infusion; Pharmaceutical form: Vial
DexamethasoneDrug
Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial
LenalidomideDrug
Route of administration: Oral; Pharmaceutical form: Capsules
PomalidomideDrug
Route of administration: Oral; Pharmaceutical form: Hard capsules
Isatuximab subcutaneous (SC)Drug
Also called SARCLISA®, SAR650984
Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial
CarfilzomibDrug
Route of administration: IV infusion; Pharmaceutical form: Vial
| Study group | Role | What they receive |
|---|---|---|
| Isatuximab | Experimental | Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol Receives: Drug: Isatuximab intravenous (IV); Drug: Cemiplimab (SAR439684); Drug: Dexamethasone; Drug: Lenalidomide; Drug: Pomalidomide; Drug: Isatuximab subcutaneous (SC); Drug: Carfilzomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events
Measured: Baseline to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start5 Apr 2023
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669989
- Sponsor's protocol ID
- LTS17704
- Other IDs
- U1111-1277-6635, 2023-507180-19, 2022-002253-26, 2023
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05669989
- Acronym / sponsor ID
- LTS17704
- Conditions
- Plasma Cell Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isatuximab | Experimental | Drug: Isatuximab intravenous (IV), Drug: Cemiplimab (SAR439684), Drug: Dexamethasone, Drug: Lenalidomide, Drug: Pomalidomide, Drug: Isatuximab subcutaneous (SC), Drug: CarfilzomibParticipants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isatuximab intravenous (IV)Also: SARCLISA®, SAR650984Route of administration: IV infusion; Pharmaceutical form: Vial | Drug | Isatuximab |
| Cemiplimab (SAR439684)Route of administration: IV infusion; Pharmaceutical form: Vial | Drug | Isatuximab |
| DexamethasoneRoute of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial | Drug | Isatuximab |
| LenalidomideRoute of administration: Oral; Pharmaceutical form: Capsules | Drug | Isatuximab |
| PomalidomideRoute of administration: Oral; Pharmaceutical form: Hard capsules | Drug | Isatuximab |
| Isatuximab subcutaneous (SC)Also: SARCLISA®, SAR650984Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial | Drug | Isatuximab |
| CarfilzomibRoute of administration: IV infusion; Pharmaceutical form: Vial | Drug | Isatuximab |
Primary outcome
Number of participants with treatment-emergent adverse events
Time frame: Baseline to 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- LTS17704 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Sciences & Operations study director
Sanofi
37 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isatuximab intravenous (IV), Cemiplimab (SAR439684) and Dexamethasone in people with Plasma Cell Myeloma, run by Sanofi at 37 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Spain, Australia, Brazil, Czechia, Greece and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (time frame: Baseline to 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.