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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001431-39 | EudraCT Number | ||
| U1111-1189-4706 | Other Identifier | UTN |
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Primary Objectives:
Secondary Objectives:
The duration of the study for a patient will include a period for screening of up to 21 days and 3-month post treatment follow up. The cycle duration is 28 days. Patients will continue treatment until disease progression, unacceptable adverse events, consent withdrawal, or any other reason.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isatuximab/cemiplimab (Regimen 1) | Experimental | Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression. Cemiplimab on Days 1 and 15 in 28-day cycle up to disease progression. |
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| Isatuximab/cemiplimab (Regimen 2) | Experimental | Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression. Cemiplimab on Day 1 in 28-day cycle up to disease progression. |
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| Isatuximab | Active Comparator | Isatuximab on Days 1, 8, 15 and 22, then Day 1 and 15 in 28-day cycles up to disease progression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isatuximab SAR650984 | Drug | Pharmaceutical form: solution for infusion Route of administration: intravenous |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Potential DLTs were defined as the occurrence of any of the following adverse reactions at first treatment cycle, unless due to disease progression or obviously unrelated cause: Hematological DLTs: Grade(G) 4 neutropenia (N) for more than 7 consecutive days, G3 to G4 N complicated by fever (temperature greater than or equal to [>=] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention or Non-hematological DLTs: G4 non-hematologic AE, G>=2 uveitis, G3 non-hematological AE lasting greater than (>)3 days despite optimal care support, delay in initiation of Cycle 2 >14 days due to treatment related laboratory abnormalities/AE. Any other AE that the investigator/study committee deemed to be dose-limiting, regardless of grade, was also considered as DLT. | Cycle 1 Day 1 to Day 28 |
| Phase 1 and Phase 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily have a causal relationship with study treatment. SAEs were 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 an AE which occurred after the first dose of study treatment administration up to 30 days after the last dose of study treatment administration. The DLT observation period was 1 cycle (28 days). However, all AEs during treatment, unless due to disease progression or an obviously unrelated cause, were taken into consideration by the Study Committee for the determination of the maximum tolerated dose and recommended Phase 2 dose. | TEAEs were collected from the first dose up to 30 days after the last dose of study treatment, approximately 50 months |
| Phase 2: Percentage of Participants With Overall Response Rate (ORR) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Percentage of Participants With Clinical Benefit Rate (CBR) | CBR by Investigator using IMWG response criteria: percentage of participants with CR (including sCR), VGPR, PR (all defined in previous OM) or MR. MR was defined as >= 25% but <= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceeded 200 mg/24h; if present at baseline, >=50% reduction in size (SPD) of soft tissue plasmacytomas was also required. |
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Inclusion criteria:
Patients must have a known diagnosis of multiple myeloma with evidence of measurable disease, as defined below:
Patients must have received prior treatment with an immunomodulatory drug (IMiD) (for ≥2 cycles or ≥2 months of treatment) and a proteasome inhibitor (PI) (for ≥2 cycles or ≥2 months of treatment).
Patients must have received at least 3 prior lines of therapy (Note: Induction therapy and stem cell transplant ± maintenance will be considered as one line).
Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible).
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado-Site Number:8400001 | Denver | Colorado | 80262 | United States | ||
| University of Kansas Medical Center-Site Number:8400003 |
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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The study consisted of 2 phases: Phase 1 confirmed the feasibility of isatuximab/cemiplimab combination and Phase 2 further evaluated safety, efficacy and pharmacokinetics (PK) of combination versus isatuximab monotherapy. Participants in Phase 2 were randomized in a 1:1:1 ratio to receive either isatuximab monotherapy or combination therapy. The duration of study for a participant included a screening period (up to 21 days) and 3-month post treatment follow-up. Each cycle duration was 28 days.
Participants were screened at 30 sites. The study was conducted i.e. participants were randomized at 29 sites in 10 countries. A total of 3 participants in Phase 1 and 106 participants in Phase 2 were enrolled (Phase 1)/randomized (Phase 2) from 21 Feb 2018 to 20 Mar 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Isatuximab + Cemiplimab Once Every 2 Weeks (Q2W) | Participants received isatuximab 10 milligram/ kilogram (mg/kg) intravenous (IV) infusion once weekly for 4 weeks (QWx4) followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable adverse events (AEs), consent withdrawal, or any other reason. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2022 | Mar 26, 2024 |
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| Cemiplimab REGN2810 | Drug | Pharmaceutical form: solution for infusion Route of administration: intravenous |
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ORR by Investigator using international myeloma working group (IMWG) response criteria:percentage of participants with complete response (CR) (including stringent CR [sCR]very good partial response [VGPR] and partial response [PR]).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,less than (<)5% plasma cells in bone marrow (BM) aspirates and normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy.VGPR:serum and urine M-protein detectable by immunofixation,not electrophoresis;>=90% reduction in serum M-protein plus urine M-protein level<100mg/24hour(h);FLC only:>=90% decrease in difference between involved and uninvolved FLC levels.PR:>=50% reduction of serum M-protein and reduction in 24h urine M-protein by >=90% or <200mg/24h.In addition to above, if present at baseline,>=50% reduction in size (sum of products of maximal perpendicular diameters of measured lesions [SPD]) of soft tissue plasmacytomas required. |
| From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
| From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
| Phase 2: Duration of Follow-up | Duration of follow-up was defined as the date of randomization to the date of last contact or death, whichever came first. Median duration of follow-up is reported. | From the date of randomization up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
| Phase 2: Duration of Response (DOR) | DOR: Time from date of first response (>=PR) that was subsequently confirmed to date of first documented progressive disease (PD) or death.DOR was determined only for participants who achieved a response of PR or better.If progression or death not observed, participant was censored at date of last valid disease assessment not showing disease progression performed prior to initiating further anticancer treatment and analysis cut-off date.PD(IMWG criteria):increase of >=25% from lowest confirmed value in any 1 of following:serum M-protein (absolute increase>=0.5 gram/deciliter[g/dL]), serum M-protein increase>=1g/dL if lowest M component >=5g/dL; urine M-component (absolute increase >=200mg/24h),appearance of new lesion(s),>=50% increase from nadir in SPD of >1 lesion or >=50% increase in longest diameter of a previous lesion >1cm in short axis,>=50% increase in circulating plasma cells (minimum 200 cells/microliter[c/mcL]) if that was the only measure of disease. PR: as defined in OM3. | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
| Phase 2: Time to Response (TTR) | TTR was defined as the time from randomization to first response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 hours. In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size SPD of soft tissue plasmacytomas was also required. | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
| Phase 2: Progression Free Survival (PFS) | PFS: Time interval from the randomization date to the date of the first documented disease progression that is subsequently confirmed or the date of death due to any cause, whichever came first. If progression or death was not observed, participant was censored at date of last valid disease assessment not showing disease progression performed prior to initiation of a further anticancer treatment or the analysis cut-off date. Analysis was performed by Kaplan-Meier method. PD (IMWG) criteria: increase of >=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase >=0.5g/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL; urine M-component (absolute increase >=200mg/24h), appearance of new lesion(s),>=50% increase from nadir in SPD of >1 lesion or >=50% increase in the longest diameter of a previous lesion >1 cm in short axis or >=50% increase in circulating plasma cells (minimum of 200 c/mcL) if that was the only measure of disease. | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
| Phase 2: Overall Survival (OS) | OS was defined as the time interval from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever came first. The results provided below corresponds to descriptive OS information at the time of primary analysis completion date of 09 October 2019. | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
| Phase 1 and 2: Plasma Concentration Observed at the End of IV Infusion (Ceoi) of Isatuximab Alone and in Combination With Cemiplimab | Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Ceoi. It was calculated using non-compartmental analysis (NCA) after the first administration in Cycle 1. The PK population was defined independently for isatuximab and cemiplimab and consisted of all participants from the all-treated (AT) population with at least 1 available concentration post-baseline (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. | At end of infusion (EOI) on Cycle 1 Day 1 |
| Phase 1 and 2: Maximum Observed Concentration (Cmax) of Isatuximab Alone and in Combination With Cemiplimab | Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Cmax. It was calculated using NCA after the first administration in Cycle 1. | At start of infusion (SOI), EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
| Phase 1 and 2: Time to Reach Cmax (Tmax) of Isatuximab Alone and in Combination With Cemiplimab | Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of tmax. It was calculated using NCA after the first administration in Cycle 1. | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
| Phase 1 and 2: Last Concentration Observed Above the Lower Limit of Quantitation (Clast) of Isatuximab Alone and in Combination With Cemiplimab | Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Clast. It was calculated using NCA after the first administration in Cycle 1. | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
| Phase 1 and 2: Time of Clast (Tlast) of Isatuximab Alone and in Combination With Cemiplimab | Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of tlast. It was calculated using NCA after the first administration in Cycle 1. | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
| Phase 1 and 2: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUClast) of Isatuximab Alone and in Combination With Cemiplimab | AUClast was defined as the area under the plasma concentration versus time curve from time 0 to real time tlast calculated using the trapezoidal method over the dosing interval after the first administration in Cycle 1. | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
| Phase 1 and 2: AUC From Time 0 to Week 1 (AUC1week) of Isatuximab Alone and in Combination With Cemiplimab | AUC1week was defined as the area under the plasma concentration versus time curve from time 0 to 1 week post dose calculated using the trapezoidal method over the dosing interval after the first administration in Cycle 1. | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
| Phase 1 and 2: Number of Participants With Anti-Drug Antibodies (ADA) to Isatuximab | ADA responses were categorized as treatment-induced ADA and treatment boosted ADA. Pre-existing ADA was defined as ADA that were present in samples drawn during the pre-treatment period. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. The ADA evaluable population was defined independently for isatuximab and cemiplimab and consisted of all participants from AT population with at least 1 ADA result (negative, positive, or inconclusive) post-baseline. | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 20 months |
| Phase 1 and 2: Number of Participants With ADA to Cemiplimab | ADA responses were categorized as treatment-induced ADA and treatment boosted ADA. Pre-existing ADA was defined as ADA that were present in samples drawn during the pre-treatment period. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 20 months |
| Kansas City |
| Kansas |
| 66160-7321 |
| United States |
| Memorial Sloan-Kettering Cancer Center-Site Number:8400002 | New York | New York | 10021 | United States |
| Fox Chase Cancer Center-Site Number:8400004 | Philadelphia | Pennsylvania | 19111 | United States |
| Investigational Site Number :0360003 | Wollongong | New South Wales | 2500 | Australia |
| Investigational Site Number :0360002 | Richmond | Victoria | 3121 | Australia |
| Investigational Site Number :0360001 | West Perth | Western Australia | 6005 | Australia |
| Investigational Site Number :0760003 | Goiânia | Goiás | 74605-020 | Brazil |
| Investigational Site Number :0760001 | Porto Alegre | Rio Grande do Sul | 90110-270 | Brazil |
| Investigational Site Number :0760004 | São Paulo | São Paulo | 01236030 | Brazil |
| Investigational Site Number :1240001 | Montreal | Quebec | H1T 2M4 | Canada |
| Investigational Site Number :1240005 | Montreal | Quebec | H4J 1C5 | Canada |
| Investigational Site Number :1240003 | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Investigational Site Number :2030002 | Brno | 62500 | Czechia |
| Investigational Site Number :2030003 | Ostrava - Poruba | 70852 | Czechia |
| Investigational Site Number :2030001 | Prague | 12808 | Czechia |
| Investigational Site Number :2500004 | Lille | 59037 | France |
| Investigational Site Number :2500002 | Nantes | 44093 | France |
| Investigational Site Number :2500003 | Pierre-Bénite | 69495 | France |
| Investigational Site Number :2500001 | Villejuif | 94800 | France |
| Investigational Site Number :3000001 | Athens | 11528 | Greece |
| Investigational Site Number :3480002 | Budapest | 1083 | Hungary |
| Investigational Site Number :3800005 | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number :3800003 | Brescia | 25123 | Italy |
| Investigational Site Number :3800001 | Torino | 10126 | Italy |
| Investigational Site Number :7240003 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Investigational Site Number :7240004 | Badalona | Catalunya [Cataluña] | 08916 | Spain |
| Investigational Site Number :7240002 | Barcelona | Catalunya [Cataluña] | 08036 | Spain |
| Investigational Site Number :7240005 | Valencia | Valenciana, Comunidad | 46017 | Spain |
| Investigational Site Number :7240006 | Madrid | 28041 | Spain |
| FG001 | Phase 2: Isatuximab | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| FG002 | Phase 2: Isatuximab + CemiplimabQ2W | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| FG003 | Phase 2: Isatuximab + Cemiplimab Once Every 4 Weeks (Q4W) | Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
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| Randomized and Treated | Enrolled for Phase1; randomized for Phase 2. Phase 2 Isatuximab + CemiplimabQ2W, one participant was randomized but not treated. |
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| COMPLETED | Participants with end of study or death from any cause forms completed. |
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| NOT COMPLETED |
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Phase 1:The Safety population: All screened participants who received at least 1 dose or a part of a dose of study treatments (isatuximab or cemiplimab), regardless of the amount of treatment administered. Phase 2: The Randomized population: All participants who gave informed consent, were assigned randomization number by interactive response technology (IRT), regardless of whether they received any study treatment or received a different study treatment from which they were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Isatuximab + CemiplimabQ2W | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 in all cycles every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| BG001 | Phase 2: Isatuximab | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| BG002 | Phase 2: Isatuximab + CemiplimabQ2W | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| BG003 | Phase 2: Isatuximab + CemiplimabQ4W | Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
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| Primary | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Potential DLTs were defined as the occurrence of any of the following adverse reactions at first treatment cycle, unless due to disease progression or obviously unrelated cause: Hematological DLTs: Grade(G) 4 neutropenia (N) for more than 7 consecutive days, G3 to G4 N complicated by fever (temperature greater than or equal to [>=] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention or Non-hematological DLTs: G4 non-hematologic AE, G>=2 uveitis, G3 non-hematological AE lasting greater than (>)3 days despite optimal care support, delay in initiation of Cycle 2 >14 days due to treatment related laboratory abnormalities/AE. Any other AE that the investigator/study committee deemed to be dose-limiting, regardless of grade, was also considered as DLT. | The DLT evaluable population consisted of participants in Phase 1 who received the planned doses of isatuximab and cemiplimab during Cycle 1, and who completed the DLT observation period of Cycle 1 after the first study treatment administration, unless they discontinued the study treatment(s) due to DLT. | Posted | Count of Participants | Participants | No | Cycle 1 Day 1 to Day 28 |
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| Primary | Phase 1 and Phase 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily have a causal relationship with study treatment. SAEs were 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 an AE which occurred after the first dose of study treatment administration up to 30 days after the last dose of study treatment administration. The DLT observation period was 1 cycle (28 days). However, all AEs during treatment, unless due to disease progression or an obviously unrelated cause, were taken into consideration by the Study Committee for the determination of the maximum tolerated dose and recommended Phase 2 dose. | Analysis was performed on the Safety population (tabulated according to treatment actually received [as treated]). There were 2 participants randomized in group isatuximab and isatuximab + cemiplimabQ4W respectively and who took another treatment/schedule. | Posted | Count of Participants | Participants | No | TEAEs were collected from the first dose up to 30 days after the last dose of study treatment, approximately 50 months |
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| Primary | Phase 2: Percentage of Participants With Overall Response Rate (ORR) | ORR by Investigator using international myeloma working group (IMWG) response criteria:percentage of participants with complete response (CR) (including stringent CR [sCR]very good partial response [VGPR] and partial response [PR]).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,less than (<)5% plasma cells in bone marrow (BM) aspirates and normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy.VGPR:serum and urine M-protein detectable by immunofixation,not electrophoresis;>=90% reduction in serum M-protein plus urine M-protein level<100mg/24hour(h);FLC only:>=90% decrease in difference between involved and uninvolved FLC levels.PR:>=50% reduction of serum M-protein and reduction in 24h urine M-protein by >=90% or <200mg/24h.In addition to above, if present at baseline,>=50% reduction in size (sum of products of maximal perpendicular diameters of measured lesions [SPD]) of soft tissue plasmacytomas required. | The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
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| Secondary | Phase 2: Percentage of Participants With Clinical Benefit Rate (CBR) | CBR by Investigator using IMWG response criteria: percentage of participants with CR (including sCR), VGPR, PR (all defined in previous OM) or MR. MR was defined as >= 25% but <= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceeded 200 mg/24h; if present at baseline, >=50% reduction in size (SPD) of soft tissue plasmacytomas was also required. | The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
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| Secondary | Phase 2: Duration of Follow-up | Duration of follow-up was defined as the date of randomization to the date of last contact or death, whichever came first. Median duration of follow-up is reported. | The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized. | Posted | Median | 95% Confidence Interval | months | From the date of randomization up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
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| Secondary | Phase 2: Duration of Response (DOR) | DOR: Time from date of first response (>=PR) that was subsequently confirmed to date of first documented progressive disease (PD) or death.DOR was determined only for participants who achieved a response of PR or better.If progression or death not observed, participant was censored at date of last valid disease assessment not showing disease progression performed prior to initiating further anticancer treatment and analysis cut-off date.PD(IMWG criteria):increase of >=25% from lowest confirmed value in any 1 of following:serum M-protein (absolute increase>=0.5 gram/deciliter[g/dL]), serum M-protein increase>=1g/dL if lowest M component >=5g/dL; urine M-component (absolute increase >=200mg/24h),appearance of new lesion(s),>=50% increase from nadir in SPD of >1 lesion or >=50% increase in longest diameter of a previous lesion >1cm in short axis,>=50% increase in circulating plasma cells (minimum 200 cells/microliter[c/mcL]) if that was the only measure of disease. PR: as defined in OM3. | The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized. Only responders were included in the analysis. | Posted | Median | Full Range | months | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
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| Secondary | Phase 2: Time to Response (TTR) | TTR was defined as the time from randomization to first response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 hours. In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size SPD of soft tissue plasmacytomas was also required. | The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized. Only responders were included in the analysis. | Posted | Median | Full Range | months | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
| |||||||||||||||||||||||||||
| Secondary | Phase 2: Progression Free Survival (PFS) | PFS: Time interval from the randomization date to the date of the first documented disease progression that is subsequently confirmed or the date of death due to any cause, whichever came first. If progression or death was not observed, participant was censored at date of last valid disease assessment not showing disease progression performed prior to initiation of a further anticancer treatment or the analysis cut-off date. Analysis was performed by Kaplan-Meier method. PD (IMWG) criteria: increase of >=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase >=0.5g/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL; urine M-component (absolute increase >=200mg/24h), appearance of new lesion(s),>=50% increase from nadir in SPD of >1 lesion or >=50% increase in the longest diameter of a previous lesion >1 cm in short axis or >=50% increase in circulating plasma cells (minimum of 200 c/mcL) if that was the only measure of disease. | The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized. | Posted | Median | 95% Confidence Interval | months | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
| |||||||||||||||||||||||||||
| Secondary | Phase 2: Overall Survival (OS) | OS was defined as the time interval from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever came first. The results provided below corresponds to descriptive OS information at the time of primary analysis completion date of 09 October 2019. | The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized. | Posted | Median | 95% Confidence Interval | months | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months |
| |||||||||||||||||||||||||||
| Secondary | Phase 1 and 2: Plasma Concentration Observed at the End of IV Infusion (Ceoi) of Isatuximab Alone and in Combination With Cemiplimab | Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Ceoi. It was calculated using non-compartmental analysis (NCA) after the first administration in Cycle 1. The PK population was defined independently for isatuximab and cemiplimab and consisted of all participants from the all-treated (AT) population with at least 1 available concentration post-baseline (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. | Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms. | Posted | Mean | Standard Deviation | microgram (mcg)/mL | At end of infusion (EOI) on Cycle 1 Day 1 |
| |||||||||||||||||||||||||||
| Secondary | Phase 1 and 2: Maximum Observed Concentration (Cmax) of Isatuximab Alone and in Combination With Cemiplimab | Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Cmax. It was calculated using NCA after the first administration in Cycle 1. | Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms. | Posted | Mean | Standard Deviation | mcg/mL | At start of infusion (SOI), EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||
| Secondary | Phase 1 and 2: Time to Reach Cmax (Tmax) of Isatuximab Alone and in Combination With Cemiplimab | Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of tmax. It was calculated using NCA after the first administration in Cycle 1. | Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms. | Posted | Median | Full Range | hour | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
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| Secondary | Phase 1 and 2: Last Concentration Observed Above the Lower Limit of Quantitation (Clast) of Isatuximab Alone and in Combination With Cemiplimab | Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Clast. It was calculated using NCA after the first administration in Cycle 1. | Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms. | Posted | Mean | Standard Deviation | mcg/mL | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||
| Secondary | Phase 1 and 2: Time of Clast (Tlast) of Isatuximab Alone and in Combination With Cemiplimab | Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of tlast. It was calculated using NCA after the first administration in Cycle 1. | Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms. | Posted | Median | Full Range | hour | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||
| Secondary | Phase 1 and 2: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUClast) of Isatuximab Alone and in Combination With Cemiplimab | AUClast was defined as the area under the plasma concentration versus time curve from time 0 to real time tlast calculated using the trapezoidal method over the dosing interval after the first administration in Cycle 1. | Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms. | Posted | Mean | Standard Deviation | (mcg*hour)/mL | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||
| Secondary | Phase 1 and 2: AUC From Time 0 to Week 1 (AUC1week) of Isatuximab Alone and in Combination With Cemiplimab | AUC1week was defined as the area under the plasma concentration versus time curve from time 0 to 1 week post dose calculated using the trapezoidal method over the dosing interval after the first administration in Cycle 1. | Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms. Only those participants with data available were analyzed. | Posted | Mean | Standard Deviation | (mcg*hour)/mL | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||
| Secondary | Phase 1 and 2: Number of Participants With Anti-Drug Antibodies (ADA) to Isatuximab | ADA responses were categorized as treatment-induced ADA and treatment boosted ADA. Pre-existing ADA was defined as ADA that were present in samples drawn during the pre-treatment period. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. The ADA evaluable population was defined independently for isatuximab and cemiplimab and consisted of all participants from AT population with at least 1 ADA result (negative, positive, or inconclusive) post-baseline. | Analysis was performed on the ADA evaluable population."Isatuximab + CemiplimabQ2W" arm includes 3 and 36 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W arms. Hence analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W arms. | Posted | Count of Participants | Participants | No | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 20 months |
| |||||||||||||||||||||||||||
| Secondary | Phase 1 and 2: Number of Participants With ADA to Cemiplimab | ADA responses were categorized as treatment-induced ADA and treatment boosted ADA. Pre-existing ADA was defined as ADA that were present in samples drawn during the pre-treatment period. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. | Analysis was performed on the ADA evaluable population. "Isatuximab + CemiplimabQ2W" arm includes 3 and 36 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W arms. Hence analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W arms. | Posted | Count of Participants | Participants | No | From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 20 months |
|
TEAEs were collected from the first dose up to 30 days after the last dose of study treatment, approximately 50 months. All-Cause Mortality was reported for the whole study duration, approximately 62 months
Analysis was performed on the Safety population (tabulated according to treatment actually received [as treated]). There were 2 participants randomized in group isatuximab and isatuximab + cemiplimabQ4W respectively and who took another treatment/schedule.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Isatuximab+Cemiplimab Q2W | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 in all cycles every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG001 | Phase 2: Isatuximab | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. | 20 | 33 | 17 | 33 | 31 | 33 |
| EG002 | Phase 2: Isatuximab + CemiplimabQ2W | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. | 23 | 37 | 17 | 37 | 34 | 37 |
| EG003 | Phase 2:Isatuximab + CemiplimabQ4W | Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. | 22 | 35 | 21 | 35 | 27 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 Pneumonia | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Catheter Site Infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Encephalomyelitis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Escherichia Bacteraemia | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Herpes Zoster Disseminated | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Parainfluenzae Virus Infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Pneumonia Staphylococcal | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Pulmonary Sepsis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 25.1 | Systematic Assessment |
| |
| Colon Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 25.1 | Systematic Assessment |
| |
| Neuroendocrine Carcinoma Of The Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hyperviscosity Syndrome | Blood and lymphatic system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| Tumour Lysis Syndrome | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDra 25.1 | Systematic Assessment |
| |
| Psychomotor Hyperactivity | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Radicular Pain | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDra 25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Acute Abdomen | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Anal Haemorrhage | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Obstruction Gastric | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Bone Lesion | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Fanconi Syndrome Acquired | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDra 25.1 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 25.1 | Systematic Assessment |
| |
| Euthanasia | Surgical and medical procedures | MedDra 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDra 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDra 25.1 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDra 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Gingival Pain | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Lip Oedema | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Oral Papule | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDra 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 25.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDra 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra 25.1 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 25.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2019 | Mar 26, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599209 | isatuximab |
| C000627974 | cemiplimab |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Phase 2: Isatuximab | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| OG002 | Phase 2: Isatuximab + CemiplimabQ2W | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| OG003 | Phase 2: Isatuximab + CemiplimabQ4W | Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
|
|
| OG001 | Phase 2: Isatuximab + CemiplimabQ2W | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| OG002 | Phase 2: Isatuximab + CemiplimabQ4W | Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
|
|
| OG002 | Phase 2: Isatuximab + CemiplimabQ4W | Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
|
|
| OG002 |
| Phase 2: Isatuximab + CemiplimabQ4W |
Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
|
|
| OG001 | Phase 2: Isatuximab + CemiplimabQ2W | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| OG002 | Phase 2: Isatuximab + CemiplimabQ4W | Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
|
|
| OG002 | Phase 2: Isatuximab + CemiplimabQ4W | Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
|
|
| OG001 | Phase 2: Isatuximab + CemiplimabQ2W | Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| OG002 | Phase 2: Isatuximab + CemiplimabQ4W | Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
|
|
| OG002 | Phase 2: Isatuximab + CemiplimabQ4W | Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
|
|
All participants who received isatuximab in combination with cemiplimab were included in this arm. |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 |
| Phase 1 and 2: Isatuximab + CemiplimabQ2W |
Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
| OG002 | Phase 2: Isatuximab + CemiplimabQ4W | Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
|
|
Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason. |
|
|