20 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)Primary· Cycle 1 (28 days)
DLTs: AEs occurring during 1st treatment cycle, assessed per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs included: Hematologic DLTs: Grade(G) 4 neutropenia(N) lasting greater than or equal to (\>=) 5 days; G3 to G4 N with fever or microbiologically or radiographically documented infection; G4 thrombocytopenia lasting for \>=5 days; thrombocytopenia, treatment delay greater than (\>)14 days due to hematologic toxicity. Non-hematologic DLTs: G\>=3 non-hematological AE, excluding G3 fatigue, G 3 to 4 electrolyte abnormalities, G3 nause
Group
Value
95% CI
Phase 1, Cohort 1: Isatuximab 10 mg/kg
0
Phase 1, Cohort 2: Isatuximab 20 mg/kg
0
Phase 2: Percentage of Participants With Overall Response (OR)Primary· From the date of the first response until the primary analysis data cut-off date of 31 July 2018 (median duration of follow-up was 24.14 weeks)
Percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) assessed by International Myeloma Working Group (IMWG) uniform response criteria. sCR: CR as defined plus normal FLC ratio \& absence of clonal cells in bone marrow. CR: negative immunofixation on serum \& urine; disappearance of any soft tissue plasmacytomas; \<5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65. VGPR: serum \& urine M-protein detectable by immunofixation; \>=90% reduction in serum M-protein plus urine M-protein leve
Group
Value
95% CI
Phase 2: Isatuximab 20 mg/kg
32.1
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Secondary· From first dose of study drug up to 30 days after the last dose of study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TESAEs was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that develop,
TEAEs
Group
Value
95% CI
Phase 1, Cohort 1: Isatuximab 10 mg/kg
3
Phase 1, Cohort 2: Isatuximab 20 mg/kg
4
TESAEs
Group
Value
95% CI
Phase 1, Cohort 1: Isatuximab 10 mg/kg
1
Phase 1, Cohort 2: Isatuximab 20 mg/kg
2
Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Secondary· From first dose of study drug up to 30 days after the last dose of study drug administration (maximum duration of exposure: up to 248 weeks)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. TESAEs was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs are defined as AEs that develop,
TEAEs
Group
Value
95% CI
Phase 2: Isatuximab 20 mg/kg
25
TESAEs
Group
Value
95% CI
Phase 2: Isatuximab 20 mg/kg
11
Phase 1: Percentage of Participants With Overall Response (OR)Secondary· From the date of the first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)
Percentage of participants with sCR, CR, VGPR, and PR assessed by IMWG uniform response criteria. sCR: CR as defined plus normal FLC ratio \& absence of clonal cells in bone marrow. CR: negative immunofixation on serum \& urine; disappearance of any soft tissue plasmacytomas; \<5 percentage (%) plasma cells in bone marrow; normal FLC ratio of 0.26-1.65. VGPR: serum \& urine M-protein detectable by immunofixation; \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hour (h); \>90% decrease in difference between involved \& uninvolved FLC levels required. PR: \>=50% reduct
Group
Value
95% CI
Phase 1, Cohort 1: Isatuximab 10 mg/kg
66.7
Phase 1, Cohort 2: Isatuximab 20 mg/kg
60.0
Phase 1: Duration of Response (DOR)Secondary· From the date of the first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)
DOR: time (in weeks) from date of first response to date of subsequent progressive disease (PD) or death, whichever happens earlier. In absence of confirmation of subsequent PD or death before cut-off date, DOR was censored at date of last valid assessment performed or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): increase (inc.) of \>=25% from lowest response value in any one of following: serum M-component (absolute inc.\>=0.5 g/dL) and/or; urine M-component (absolute inc.\>=200 mg/24h) and/or, in participants without measurable serum \& urine M-p
Group
Value
95% CI
Phase 1, Cohort 1: Isatuximab 10 mg/kg
100.64
± 7.78
Phase 1, Cohort 2: Isatuximab 20 mg/kg
113.90
± 18.45
Phase 2: Percentage of Participants With Clinical Benefit (CB)Secondary· From date of first study treatment administration until first documented response, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)
CB defined as percentage of participants with sCR, CR, VGPR, PR or Minor/minimal response (MR) assessed by IMWG criteria. sCR: CR as defined plus normal FLC ratio \& absence of clonal cells. CR: negative immunofixation on serum \& urine; disappearance of any soft tissue plasmacytomas; \<5% plasma cells in bone marrow; normal FLC ratio: 0.26-1.65. VGPR: serum \& urine M-protein detectable by immunofixation; \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24h; \>90% decrease in difference between involved \& uninvolved FLC levels required. PR: \>=50% reduction of serum M-
Group
Value
95% CI
Phase 2: Isatuximab 20 mg/kg
53.6
Phase 2: Overall Survival (OS)Secondary· From date of first study treatment administration to the date of death due to any cause (maximum duration of exposure: up to 248 weeks)
Overall survival was defined as the time interval (in months) from the date of first study treatment administration to death due to any cause. In the absence of the confirmation of death before the cut-off date, OS was censored at the last date the participant was known to be alive or at the study cut-off date, whichever was earlier. Analysis was performed by Kaplan-Meier method.
Group
Value
95% CI
Phase 2: Isatuximab 20 mg/kg
NA
20.24 – NA
Phase 2: Progression Free Survival (PFS)Secondary· From date of first study treatment administration until disease progression or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)
PFS was defined as the time interval (in months) from date of first study treatment administration until disease progression or death due to any cause, whichever comes first. In absence of PD or death, PFS was censored at date of last valid assessment performed before cut-off date or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): inc. of \>=25% in any one of following: serum M-component absolute (abs.) inc. \>=0.5 g/dL) and/or; urine M-component (abs. inc. \>=200 mg/24h) and/or, in participants without measurable serum \& urine M-protein, difference
Group
Value
95% CI
Phase 2: Isatuximab 20 mg/kg
5.6
3.75 – 12.98
Phase 2: Duration of Response (DOR)Secondary· From the date of first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)
DOR was defined as time (in weeks) from date of first response to date of subsequent progressive disease (PD) or death, whichever happens earlier. In absence of confirmation of subsequent PD or death before cut-off date, DOR was censored at date of last valid assessment performed or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria):inc. of \>=25% from lowest response value in any one of following: serum M-component (absolute inc.\>=0.5 g/dL) and/or; urine M-component (absolute inc.\>=200 mg/24h) and/or, in participants without measurable serum \& urine M
Group
Value
95% CI
Phase 2: Isatuximab 20 mg/kg
58.70
± 29.91
Phase 2: Time to Progression (TTP)Secondary· From date of first study treatment administration until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)
TTP: time interval (in months) from date of first study treatment administration to date of first assessed disease progression. In absence of disease progression, TTP was censored at date of last valid assessment performed before cut-off date or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): inc. of \>=25% from lowest response value in any one of following: serum M-component (absolute inc.\>=0.5 g/dL) and/or; urine M-component (absolute inc.\>=200 mg/24h) and/or, in participants without measurable serum \& urine M-protein: difference between involved
Group
Value
95% CI
Phase 2: Isatuximab 20 mg/kg
5.5
3.745 – 12.977
Phase 1: Plasma Concentration Observed at the End of Intravenous Infusion (Ceoi) of IsatuximabSecondary· End of infusion on Day 1 of Cycle 1
Ceoi is the plasma concentration observed at the end of intravenous infusion.
Group
Value
95% CI
Phase 1, Cohort 1: Isatuximab 10 mg/kg
122
± 21.6
Phase 1, Cohort 2: Isatuximab 20 mg/kg
246
± 51.8
Adverse events — posted to ClinicalTrials.gov
Time frame: AE data was collected from first dose of study drug up to 30 days after last dose of study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1, and 137 weeks for Cohort 2 for Phase 1 part; and up to 248 weeks for Phase 2 part).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1, Cohort 1: Isatuximab 10 mg/kg
Serious: 1/3 (33%)
Deaths: 1/3
Phase 1, Cohort 2: Isatuximab 20 mg/kg
Serious: 2/5 (40%)
Deaths: 2/5
Phase 2: Isatuximab 20 mg/kg
Serious: 11/28 (39%)
Deaths: 10/28
Serious adverse events (23 terms)
Reaction
System
Phase 1, Cohort 1: Isatuxi…
Phase 1, Cohort 2: Isatuxi…
Phase 2: Isatuximab 20 mg/kg
Pneumonia
Infections and infestations
—
—
—
Disseminated Intravascular Coagulation
Blood and lymphatic system disorders
—
—
—
Cataract
Eye disorders
—
—
—
Ileus
Gastrointestinal disorders
—
—
—
Large Intestine Polyp
Gastrointestinal disorders
—
—
—
Disease Progression
General disorders
—
—
—
Non-Cardiac Chest Pain
General disorders
—
—
—
Anal Abscess
Infections and infestations
—
—
—
Intervertebral Discitis
Infections and infestations
—
—
—
Lung Infection
Infections and infestations
—
—
—
Sinusitis
Infections and infestations
—
—
—
Diabetic Ketoacidosis
Metabolism and nutrition disorders
—
—
—
Osteonecrosis Of Jaw
Musculoskeletal and connective tissue disorders
—
—
—
Synovial Cyst
Musculoskeletal and connective tissue disorders
—
—
—
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Gastrointestinal Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primary Objectives:
* Phase I: To evaluate safety and tolerability of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.
* Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.
Secondary Objectives:
* To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events were assessed.
* To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule.
* To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria.
* To assess the relationship between Baseline cluster of differentiation 38 (CD38) receptor density on multiple myeloma cells and efficacy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04661033 — Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA
· Phase 2
· terminated
NCT04294459 — Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
· Phase 1, PHASE2
· terminated
NCT04270409 — Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
· Phase 3
· active not recruiting
NCT03733717 — Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or
· Phase 1
· completed
NCT03637764 — Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With
· Phase 1, PHASE2
· terminated
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Currently open trials in the same condition.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 1 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02812706.