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Monoclonal Antibodies
Isatuximab SAR650984 for Blood Cancers
Phase 1 & 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for q2w:cycle 1,day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; for qw: cycle 1,day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
Awards & highlights
Study Summary
This trial is testing a drug called Isatuximab to see if it is safe and effective for treating Multiple Myeloma. The trial is divided into two stages, with the first stage testing different doses and schedules of the drug to see what is the best dose and schedule to use. The second stage will test the selected dose and schedule from stage 1 to see if the drug is effective at treating Multiple Myeloma.
Eligible Conditions
- Blood Cancers
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for q2w:cycle 1,day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; for qw: cycle 1,day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for q2w:cycle 1,day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; for qw: cycle 1,day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Phase 2 Stage 1: Percentage of Participants With Overall Response (OR) According to International Myeloma Working Group (IMWG) Uniform Response Criteria
+1 moreSecondary outcome measures
Clinical Assessment: Phase 1: Duration of Response (DOR)
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (Karnofsky Performance Status)-Shift From Baseline Value to Best Value During Treatment
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment
+29 moreSide effects data
From 2023 Phase 1 & 2 trial • 351 Patients • NCT0108425250%
Fatigue
38%
Anaemia
31%
Infusion Related Reaction
31%
Headache
25%
Nausea
25%
Chills
25%
Pyrexia
19%
Cough
19%
Diarrhoea
13%
Contusion
13%
Oedema Peripheral
13%
Vision Blurred
13%
Hypercalcaemia
13%
Thrombocytopenia
13%
Vomiting
13%
Urinary Tract Infection
13%
Blood Creatinine Increased
13%
Lymphocyte Count Decreased
13%
Bone Pain
13%
Pain In Extremity
13%
Dysgeusia
13%
Dyspnoea
6%
Pain
6%
Herpes Simplex
6%
Upper Respiratory Tract Infection
6%
Groin Pain
6%
Dizziness
6%
Sinusitis
6%
Back Pain
6%
Abnormal Dreams
6%
Abdominal Pain
6%
Abdominal Pain Upper
6%
Gastrointestinal Pain
6%
Otitis Media
6%
Myelodysplastic Syndrome
6%
Meningitis Bacterial
6%
Constipation
6%
Acute Kidney Injury
6%
Bradycardia
6%
Glossodynia
6%
Stomatitis
6%
Respiratory Tract Infection
6%
Balance Disorder
6%
Dry Mouth
6%
Gastrooesophageal Reflux Disease
6%
Disease Progression
6%
Influenza Like Illness
6%
Malaise
6%
Cytokine Release Syndrome
6%
Bronchitis
6%
Limb Discomfort
6%
Muscle Spasms
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Head Discomfort
6%
Peripheral Sensory Neuropathy
6%
Agitation
6%
Bradyphrenia
6%
Depression
6%
Insomnia
6%
Irritability
6%
Productive Cough
6%
Throat Lesion
6%
Dermatitis Contact
6%
Hypertension
6%
Onychoclasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Isatuximab 1mg/kg Q2W
Phase 1: Isatuximab 20mg/kg QW
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Phase 1: Isatuximab 3mg/kg Q2W
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Phase 1: Isatuximab 20mg/kg Q2W
Phase 2 Stage 2: Isatuximab Alone
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Phase 1: Isatuximab 5mg/kg Q2W
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Phase 2 Stage 2: Isatuximab + Dexamethasone
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Phase 1: Isatuximab 10mg/kg QW
Trial Design
14Treatment groups
Experimental Treatment
Group I: Phase2 Stage1a:Isatuximab 10mg/kg Q2W; Then Q4WExperimental Treatment1 Intervention
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 week (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
Group II: Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)Experimental Treatment1 Intervention
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Group III: Phase 2 Stage 2: Isatuximab AloneExperimental Treatment1 Intervention
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision maximum exposure: 97 weeks).
Group IV: Phase 2 Stage 2: Isatuximab + DexamethasoneExperimental Treatment2 Interventions
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day [greater than or equal to [>=] for 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Group V: Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2WExperimental Treatment1 Intervention
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
Group VI: Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2WExperimental Treatment1 Intervention
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable adverse event (AE), disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
Group VII: Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2WExperimental Treatment1 Intervention
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
Group VIII: Phase 1:Isatuximab <=1 mg/kg Q2WExperimental Treatment1 Intervention
Participants with CD38+ hematological malignancies (HM), received Isatuximab at any one of the dose less than or equal to (<=) 1 milligram per kilogram (mg/kg) (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as intravenous (IV) infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Group IX: Phase 1:Isatuximab (CD38 + HM and High Risk Multiple Myeloma)Experimental Treatment1 Intervention
Participants with CD38+ HM along with participants with high risk multiple myeloma, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Group X: Phase 1: Isatuximab 5 mg/kg Q2WExperimental Treatment1 Intervention
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Group XI: Phase 1: Isatuximab 3mg/kg Q2WExperimental Treatment1 Intervention
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Group XII: Phase 1: Isatuximab 20 mg/kg QWExperimental Treatment1 Intervention
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Group XIII: Phase 1: Isatuximab 20 mg/kg Q2WExperimental Treatment1 Intervention
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Group XIV: Phase 1: Isatuximab 10 mg/kg QWExperimental Treatment1 Intervention
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Isatuximab SAR650984
2015
Completed Phase 2
~580
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,629 Total Patients Enrolled
1 Trials studying Blood Cancers
25 Patients Enrolled for Blood Cancers
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,488 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have there been any prior investigations concerning Isatuximab SAR650984?
"Presently, there are 568 clinical trials associated with Isatuximab SAR650984; 145 of these studies have advanced to the third phase. While Mishawaka, Indiana is home to a majority of the mentioned investigations, 19151 locations across the globe offer this medication as part of their research protocols."
Answered by AI
How many participants are included in this medical experiment?
"At the moment, new participants are no longer being accepted into this trial; it was first posted on June 10th 2010 and last amended on June 16th 2022. If you seek other studies, there currently exist 2521 ongoing research projects involving hematological neoplasms and 568 trials for Isatuximab SAR650984 recruiting individuals."
Answered by AI
How many locations are currently hosting this research study?
"The following three centres are recruiting for this medical trial: Investigational Site Number 840010 in Chicago, Illinois; Investigational Site Number 840005 in San Francisco, California; and Investigational Site Number 840027 in Detroit, Michigan. An additional 16 locations have also opened their doors to recruitment initiatives."
Answered by AI
What conditions typically warrant a prescription for Isatuximab SAR650984?
"Isatuximab SAR650984 is an effective treatment for ophthalmic and sympathetic conditions. In addition, it can be used to abate symptoms of communicable diseases like branch retinal vein occlusion and macular edema."
Answered by AI
Are there any available slots for participants in this clinical experiment?
"Currently, this medical trial is not accepting enrollees. Initially posted on June 10th 2010 and last updated on June 16th 2022, if you are searching for another study to join there are 2,521 active clinical trials researching hematological neoplasms and 568 studies actively enrolling participants in Isatuximab SAR650984-related research."
Answered by AI
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