Trial Outcomes & Findings for Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia (NCT NCT02999633)
NCT ID: NCT02999633
Last Updated: 2022-03-21
Results Overview
Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Baseline until disease progression or death (maximum duration: 12.1 weeks)
Results posted on
2022-03-21
Participant Flow
The study was conducted in 6 countries. A total of 16 participants were screened of those 2 participants failed screening: 1 participant for evidence of ongoing infection and 1 participant for not meeting the criterion for relapsed or refractory T-acute lymphoblastic leukemia (ALL)/T-lymphoblastic lymphoma (LBL).
The first participant was enrolled on 14 March 2017. A total of 14 participants were enrolled to receive isatuximab. The study was early terminated on 08 Nov 2017 due to an unsatisfactory benefit/risk ratio.
Participant milestones
| Measure |
Isatuximab
Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Isatuximab
Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Progressive disease
|
12
|
Baseline Characteristics
Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Isatuximab
n=14 Participants
Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
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|---|---|
|
Age, Continuous
|
41.36 years
STANDARD_DEVIATION 19.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline until disease progression or death (maximum duration: 12.1 weeks)Population: Safety analysis set included all participants who received at least 1 dose of isatuximab.
Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC.
Outcome measures
| Measure |
Isatuximab
n=14 Participants
Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
|
|---|---|
|
Percentage of Participants With Objective Response
|
0 percentage of participants
Interval 0.0 to 23.2
|
SECONDARY outcome
Timeframe: Baseline until disease progression or death (maximum duration: 12.1 weeks)Population: The outcome measure was not analyzed due to lack of objective response. There was no specific additional data collected for the analysis of DOR as this outcome measure was to be derived using time point responses and death information that were collected and analyzed as part of primary and safety outcome measures, respectively.
DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. Progressive disease as per NCCN guidelines was defined as increase of at least 25 percentage (%) in the absolute number of circulating or bone marrow blasts or development of extramedullary disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until disease progression or death (maximum duration: 12.1 weeks)Population: This outcome measure was not analyzed because disease progression data were not collected.
PFS was defined as the time interval (in days) from the date of first study drug administration to the date of first observation of PD or death due to any cause, whichever came first. PD as per NCCN guidelines was defined as increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until death (maximum duration: 12.1 weeks)Population: This outcome measure was not analyzed because overall survival data were not collected.
Overall Survival was defined as the time interval from the date of first study drug administration to the date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until death or study cut-off (maximum duration: 12.1 weeks)Population: Data for this outcome measure was not collected and analyzed because no participant achieved CR or CRi.
Presence of MRD was measured by sequencing and/or flow cytometry in participants achieving CR and CRi. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, ANC greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. Complete response with incomplete blood count recovery meet all criteria for complete response except platelet count and/or ANC.
Outcome measures
Outcome data not reported
Adverse Events
Isatuximab
Serious events: 10 serious events
Other events: 12 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Isatuximab
n=14 participants at risk
Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
|
|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Cardiac disorders
Pericarditis Constrictive
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Gastrointestinal disorders
Pancreatitis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
General disorders
Disease Progression
|
28.6%
4/14 • Number of events 4 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Infections and infestations
Device Related Infection
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Infections and infestations
Fungal Infection
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Infections and infestations
Periorbital Cellulitis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Vascular disorders
Pelvic Venous Thrombosis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Vascular disorders
Vein Collapse
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
Other adverse events
| Measure |
Isatuximab
n=14 participants at risk
Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14 • Number of events 2 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Cardiac disorders
Tachycardia
|
14.3%
2/14 • Number of events 2 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • Number of events 2 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
2/14 • Number of events 2 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
General disorders
Asthenia
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
General disorders
Pyrexia
|
35.7%
5/14 • Number of events 6 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Hepatobiliary disorders
Cholangitis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Hepatobiliary disorders
Cholecystitis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Immune system disorders
Cytokine Release Syndrome
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Infections and infestations
Bronchiolitis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Infections and infestations
Device Related Infection
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Infections and infestations
Oral Herpes
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Infections and infestations
Pyelitis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Infections and infestations
Rhinitis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
57.1%
8/14 • Number of events 11 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Investigations
Body Temperature Increased
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Investigations
Weight Decreased
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
2/14 • Number of events 2 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
14.3%
2/14 • Number of events 2 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
7.1%
1/14 • Number of events 2 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Musculoskeletal and connective tissue disorders
Muscle Oedema
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Nervous system disorders
Facial Paralysis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 2 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Nervous system disorders
Sciatica
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Renal and urinary disorders
Urinary Retention
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Number of events 2 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
|
Vascular disorders
Phlebitis
|
7.1%
1/14 • Number of events 1 • Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER