Multiple MyelomaPhase 1NCT04045795
Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
A Phase 1 study testing isatuximab SAR650984 IV, pomalidomide and dexamethasone in people with Multiple Myeloma, run by Sanofi at 14 sites in 6 countries.
Trial summary
Primary Objectives: To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device To evaluate the pharmacokinetics… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- isatuximab SAR650984 IV, pomalidomide and dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 6 Aug 2019to 27 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Participant must be above 18 years of age or country's legal age of majority if the legal age is >18 years old, at the time of signing the informed consent.
- Participant has been previously diagnosed with multiple myeloma (MM) based on standard criteria and currently requires treatment because MM has relapsed following a response, according to International Myeloma Working Group (IMWG) criteria.
- Participant has received at least two previous therapies including lenalidomide and a proteasome inhibitor and has demonstrated disease progression on last therapy or after completion of the last therapy.
- Participants with measurable disease defined as at least one of the following:
- Serum M protein ≥ 0.5 g/dL (≥5 g/L).
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- Urine M protein ≥ 200 mg/24 hours.
- Serum free light chain (FLC) assay: Involved FLC assay ≥ 10 mg/dL (≥ 100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
- Male or female: Contraceptive use by men or women
Who cannot join
- Malignancy within 3 years prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score >2.
- Inadequate hematological, liver or renal function.
- Serum calcium (corrected for albumin) level above the upper limit of normal (ULN) range.
- Patients with prior anti-CD38 treatment are excluded if:
- Refractory to anti-CD38 treatment defined as progression on or within 60 days of the last dose of the anti-CD38 or,
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- Intolerant to the anti-CD38 previously received or,
- Progression after initial response on anti-CD38 therapy with a washout period inferior to 9 months before the first dose of isatuximab SC or IV.
- Participant did not achieve a minimal response or better to at least one of the previous lines of treatment (ie, primary refractory disease is not eligible).
- Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
- Prior anti-cancer therapy within 14 days.
- Any >Grade 1 adverse reaction unresolved from previous treatments according to the NCI-CTCAE v5.0. The presence of alopecia or peripheral neuropathy ≤ Grade 2 without pain is allowed.
- Previous allogeneic stem cell transplantation with active Graft Versus Host Disease or being under immunosuppressive therapy in the last 2 months previously to the inclusion in the trial.
- Daily requirement for corticosteroids.
- Known to be HIV+ or to have hepatitis A or uncontrolled or active hepatitis B virus (HBV) infection (patients with positive HBsAg [HBsAg] and/or HBV DNA) or active HCV (HCV) infection (positive HCV RNA and negative anti-HCV).
- Active tuberculosis and severe infections requiring treatment with antibiotic parenteral administration.
- Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the patient or may interfere with compliance or interpretation of the study results.
- History of erythema multiforme or severe hypersensitivity to prior immunomodulatory drugs (IMiDs).
- Hypersensitivity or history of intolerance to immunomodulatory drugs (IMiDs), dexamethasone, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study therapy that are not amenable to premedication with steroids and histamine H2 blockers or would prohibit further treatment with these agents.
- Inability to tolerate thromboprophylaxis.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
Australia4 sites
Investigational Site Number : 0360002
Blacktown, New South Wales, 2148
Investigational Site Number : 0360004
Fitzroy, Victoria, 3065
Investigational Site Number : 0360003
Richmond, Victoria, 3121
Investigational Site Number : 0360001
Wollongong, New South Wales, 2500
United States3 sites
Gabrail Cancer Center Site Number : 8400001
Canton, Ohio, 44718
City of Hope Site Number : 8400002
Duarte, California, 91010
~Banner MD Anderson Cancer Center Site Number : 8400005
Gilbert, Arizona, 85234
France2 sites
Investigational Site Number : 2500001
Nantes, 44093
Investigational Site Number : 2500002
Toulouse, 31059
Japan2 sites
Investigational Site Number : 3920002
Okayama, Okayama-ken, 701-1192
Investigational Site Number : 3920001
Shibuya-ku, Tokyo, 150-8935
Spain2 sites
Investigational Site Number : 7240001
Badalona, Catalunya [Cataluña], 08916
Investigational Site Number : 7240002
Santander, Cantabria, 39008
About this study
Official title: A Multi-center, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Efficacy of Subcutaneous and Intravenous Isatuximab (SAR650984) in Combination With Pomalidomide and Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
Primary Objectives:
- To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV)
- To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device
- To evaluate the pharmacokinetics (PK) of SC and IV isatuximab
Read more
Secondary Objectives:
- To estimate absolute bioavailability of SC and IV isatuximab
- To measure receptor occupancy (RO) after isatuximab SC versus IV administration
- To assess efficacy of isatuximab after SC and IV administration
- To assess patient expectations prior to and patient experience and satisfaction after SC administration
- To evaluate potential immunogenicity of SC or IV isatuximab
Read the detailed description
Total study duration is variable depending on treatment and follow-up periods, including 21 days of screening, and treatment period until disease progression, unacceptable adverse reaction or other reason for discontinuation. End of treatment will be 30 days after last administration of investigational medicinal product, or before further anti-myeloma therapy, whichever comes first; approximately 14 months after first study treatment administration.
- Conditions
- Multiple Myeloma
- Being tested
- isatuximab SAR650984 IV, pomalidomide, dexamethasone, isatuximab SAR650984 SC, Investigational injector device
- Keywords
- Anti-CD38 monoclonal antibody
- 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 SAR650984 IVDrug
Also called Sarclisa
Pharmaceutical form: solution
Route of administration: intravenous
pomalidomideDrug
Also called Pomalyst®
Pharmaceutical form: tablet
Route of administration: oral
dexamethasoneDrug
Also called Decadron®
Pharmaceutical form: tablet
Route of administration: oral
isatuximab SAR650984 SCDrug
Pharmaceutical form: solution
Route of administration: subcutaneous
Investigational injector deviceDevice
Subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Dose regimen 1 | Experimental | Isatuximab SC administration dose level 1 once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle Receives: Drug: pomalidomide; Drug: dexamethasone; Drug: isatuximab SAR650984 SC |
| Dose regimen 2 | Experimental | Isatuximab SC administration dose level 2 once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle Receives: Drug: pomalidomide; Drug: dexamethasone; Drug: isatuximab SAR650984 SC |
| Dose regimen 3 | Experimental | Isatuximab SC administration dose level 3 using the investigational injector device once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle Receives: Drug: pomalidomide; Drug: dexamethasone; Drug: isatuximab SAR650984 SC; Device: Investigational injector device |
| Dose regimen 4 | Experimental | Isatuximab IV administration once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle Receives: Drug: isatuximab SAR650984 IV; Drug: pomalidomide; Drug: dexamethasone |
| Dose regimen 5 | Experimental | Isatuximab IV administration once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle Receives: Drug: isatuximab SAR650984 IV; Drug: pomalidomide; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse events (AEs)
Number of participants with adverse events
Measured: Baseline to 30 days after last study treatment administration (up to approximately 14 months after first study treatment administration)
Pharmacokinetic (PK) assessment: Ceoi
Concentration observed at the end of infusion (Ceoi)
Measured: Baseline to end of treatment (EOT) after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
PK assessment: Cmax
Maximum concentration observed after the first infusion (Cmax)
Measured: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
PK assessment: tmax
Time to reach Cmax (tmax)
Measured: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
PK assessment: Clast
Last concentration observed above the lower limit of quantification after the first infusion (Clast)
Measured: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
PK assessment: tlast
Time of Clast (tlast)
Measured: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
PK assessment: Ctrough
Concentration observed just before treatment administration during repeated dosing (Ctrough)
Measured: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
PK assessment: AUClast
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to time of the last concentration observed above the lower limit of quantification (ie, Clast) (AUClast)
Measured: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
PK assessment: AUC0 T
Area under the plasma concentration versus time curve calculated over the dosing interval T (168h or 336h) (AUC0 T)
Measured: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
Secondary outcomes (11)
Estimation of absolute bioavailability of isatuximab
Absolute bioavailability of isatuximab SC, expressed as a percentage, estimated from AUC0-168h obtained after intravenous (IV) and extravascular (EV) administration
Measured: Day 8
Overall response rate (ORR)
ORR is the proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) using the IMWG response criteria
Measured: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Duration of response (DOR)
Time from the date of the first response to the date of first progressive disease (PD) or death, whichever happens first
Measured: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Time to response (TTR)
Time from the date of first study treatment to the first response
Measured: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Time to progression (TTP)
Time from date of first study treatment to date of first documentation of progressive disease
Measured: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Overall survival (OS)
Time from the date of first study treatment to date of death from any cause
Measured: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Clinical benefit rate (CBR)
Proportion of patients with sCR, CR, VGPR, PR or minimal response (MR) according to IMWG criteria
Measured: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Progression free survival (PFS)
Time from date of first study treatment to date of first documentation of progressive disease or death
Measured: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Comparison of patient expectations and satisfaction: Patient Expectations and Satisfaction Questionnaires
Comparison of patient expectations and satisfaction will be assessed using Patient Expectations and Satisfaction Questionnaires before and after subcutaneous (SC) administration, where a score of 1 = not satisfied and a score of 5 = extremely satisfied
Measured: Cycles 1 and 2 (28 days per Cycle), and 30 days after last isatuximab administration (up to approximately 14 months after first study treatment administration)
Immunogenicity: Anti drug antibody levels
Incidence of patients with anti drug antibodies against isatuximab
Measured: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
Biomarker: Change in CD38 receptor occupancy
Change in CD38 receptor occupancy from baseline
Measured: At screening and at Day 1 of Cycle 2 (28 days per Cycle) (predose); to be stopped once the isatuximab SC dose has been selected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start6 Aug 2019
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
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
- NCT04045795
- Sponsor's protocol ID
- TCD15484
- Other IDs
- U1111-1211-9525, 2018-001996-19, 2018
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Efficacy of Subcutaneous and Intravenous Isatuximab (SAR650984) in Combination With Pomalidomide and Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
- ClinicalTrials.gov ID
- NCT04045795
- Acronym / sponsor ID
- TCD15484
- Conditions
- Multiple Myeloma
- Keywords
- Anti-CD38 monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 6 Aug 2019 (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.
Primary Objectives:
- To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV)
- To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device
- To evaluate the pharmacokinetics (PK) of SC and IV isatuximab
Secondary Objectives:
- To estimate absolute bioavailability of SC and IV isatuximab
- To measure receptor occupancy (RO) after isatuximab SC versus IV administration
- To assess efficacy of isatuximab after SC and IV administration
- To assess patient expectations prior to and patient experience and satisfaction after SC administration
- To evaluate potential immunogenicity of SC or IV isatuximab
Detailed description
Total study duration is variable depending on treatment and follow-up periods, including 21 days of screening, and treatment period until disease progression, unacceptable adverse reaction or other reason for discontinuation. End of treatment will be 30 days after last administration of investigational medicinal product, or before further anti-myeloma therapy, whichever comes first; approximately 14 months after first study treatment administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose regimen 1 | Experimental | Drug: pomalidomide, Drug: dexamethasone, Drug: isatuximab SAR650984 SCIsatuximab SC administration dose level 1 once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle |
| Dose regimen 2 | Experimental | Drug: pomalidomide, Drug: dexamethasone, Drug: isatuximab SAR650984 SCIsatuximab SC administration dose level 2 once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle |
| Dose regimen 3 | Experimental | Drug: pomalidomide, Drug: dexamethasone, Drug: isatuximab SAR650984 SC, Device: Investigational injector deviceIsatuximab SC administration dose level 3 using the investigational injector device once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle |
| Dose regimen 4 | Experimental | Drug: isatuximab SAR650984 IV, Drug: pomalidomide, Drug: dexamethasoneIsatuximab IV administration once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle |
| Dose regimen 5 | Experimental | Drug: isatuximab SAR650984 IV, Drug: pomalidomide, Drug: dexamethasoneIsatuximab IV administration once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Participant must be above 18 years of age or country's legal age of majority if the legal age is >18 years old, at the time of signing the informed consent.
- Participant has been previously diagnosed with multiple myeloma (MM) based on standard criteria and currently requires treatment because MM has relapsed following a response, according to International Myeloma Working Group (IMWG) criteria.
- Participant has received at least two previous therapies including lenalidomide and a proteasome inhibitor and has demonstrated disease progression on last therapy or after completion of the last therapy.
- Participants with measurable disease defined as at least one of the following:
Key exclusion criteria (21 listed)
- Malignancy within 3 years prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score >2.
- Inadequate hematological, liver or renal function.
- Serum calcium (corrected for albumin) level above the upper limit of normal (ULN) range.
- Patients with prior anti-CD38 treatment are excluded if:
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 SAR650984 IVAlso: SarclisaPharmaceutical form: solution Route of administration: intravenous | Drug | Dose regimen 4, Dose regimen 5 |
| pomalidomideAlso: Pomalyst®Pharmaceutical form: tablet Route of administration: oral | Drug | Dose regimen 1, Dose regimen 2, Dose regimen 3, Dose regimen 4, Dose regimen 5 |
| dexamethasoneAlso: Decadron®Pharmaceutical form: tablet Route of administration: oral | Drug | Dose regimen 1, Dose regimen 2, Dose regimen 3, Dose regimen 4, Dose regimen 5 |
| isatuximab SAR650984 SCPharmaceutical form: solution Route of administration: subcutaneous | Drug | Dose regimen 1, Dose regimen 2, Dose regimen 3 |
| Investigational injector deviceSubcutaneous administration | Device | Dose regimen 3 |
Primary outcome
Assessment of adverse events (AEs)
Time frame: Baseline to 30 days after last study treatment administration (up to approximately 14 months after first study treatment administration)
Number of participants with adverse events
Pharmacokinetic (PK) assessment: Ceoi
Time frame: Baseline to end of treatment (EOT) after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
Concentration observed at the end of infusion (Ceoi)
PK assessment: Cmax
Time frame: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
Maximum concentration observed after the first infusion (Cmax)
PK assessment: tmax
Time frame: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
Time to reach Cmax (tmax)
PK assessment: Clast
Time frame: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
Last concentration observed above the lower limit of quantification after the first infusion (Clast)
PK assessment: tlast
Time frame: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
Time of Clast (tlast)
PK assessment: Ctrough
Time frame: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
Concentration observed just before treatment administration during repeated dosing (Ctrough)
PK assessment: AUClast
Time frame: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to time of the last concentration observed above the lower limit of quantification (ie, Clast) (AUClast)
PK assessment: AUC0 T
Time frame: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
Area under the plasma concentration versus time curve calculated over the dosing interval T (168h or 336h) (AUC0 T)
11 secondary outcomes
Estimation of absolute bioavailability of isatuximab
Time frame: Day 8
Overall response rate (ORR)
Time frame: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Duration of response (DOR)
Time frame: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Time to response (TTR)
Time frame: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Time to progression (TTP)
Time frame: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Overall survival (OS)
Time frame: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Clinical benefit rate (CBR)
Time frame: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Progression free survival (PFS)
Time frame: From day -21 to day 60 after last study treatment (up to approximately 14 months after first study treatment administration)
Comparison of patient expectations and satisfaction: Patient Expectations and Satisfaction Questionnaires
Time frame: Cycles 1 and 2 (28 days per Cycle), and 30 days after last isatuximab administration (up to approximately 14 months after first study treatment administration)
Immunogenicity: Anti drug antibody levels
Time frame: Baseline to EOT after isatuximab SC and to Cycle 10 after IV (28 days per Cycle)
Biomarker: Change in CD38 receptor occupancy
Time frame: At screening and at Day 1 of Cycle 2 (28 days per Cycle) (predose); to be stopped once the isatuximab SC dose has been selected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- TCD15484 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. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing isatuximab SAR650984 IV, pomalidomide and dexamethasone in people with Multiple Myeloma, run by Sanofi at 14 sites in 6 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 9 inclusion and 21 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: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Australia, United States, France, Japan, Spain and 1 more country. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of adverse events (AEs) (time frame: Baseline to 30 days after last study treatment administration (up to approximately 14 months after first study treatment administration)). The study lists 9 primary outcomes in all. 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 12 Sep 2025.