Back to resultsEvaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Isatuximab SAR650984
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Anti-CD38 monoclonal antibody
Eligibility Criteria
Inclusion criteria:
- Known diagnosis of symptomatic multiple myeloma.
- At least 2 prior lines of therapies which must include treatment with at least 1 of an immunomodulatory drug (IMiD) or a proteasome inhibitor (PI). The patients must have received an IMiD or a PI for ≥2 cycles or ≥2 months of treatment.
- Patients must have been responsive to at least 1 prior line of therapy (minimal response or better).
- Refractory to the most recently received IMiD or PI included therapy (ie, patients must have progressed during or within 60 days of completion of treatment with IMiD or PI). For patients who have received more than 1 type of IMiD or PI, their disease must be refractory to the most recent one.
Measurable disease defined as at least 1 of the following:
- Serum M-protein ≥0.5 g/dL (≥5 g/L);
- Urine M-protein ≥200 mg/24 hours.
- Written informed consent.
Exclusion criteria:
- <18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status >2.
- Life expectancy of less than 3 months.
- Pretreated with any anticluster of differentiation (CD) 38 agent.
- Concurrent plasma cell leukemia.
- Known amyloidosis.
- Disease measurable only by serum free light chain (FLC) analysis.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 1560003
- Investigational Site Number 1560002
- Investigational Site Number 1560001
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Isatuximab
Arm Description
Administered intravenously every week in Cycle 1 (4 weeks) followed by every 2 weeks (Q2W) in subsequent cycles.
Outcomes
Primary Outcome Measures
Assessment of PK: Cmax
To evaluate the maximum observed concentration (Cmax)
Assessment of PK: tmax
To evaluate the time to reach Cmax (tmax)
Assessment of PK: AUC0-168h
To evaluate area under the plasma concentration versus time curve over the dosing interval (AUC0-168h)
Assessment of PK: Ceoi
To evaluate the concentration observed at the end of an IV infusion (Ceoi)
Assessment of PK: Ctrough
To evaluate concentration observed just before investigational medicinal product (IMP) administration during repeated dosing (Ctrough)
Secondary Outcome Measures
Adverse Events
Treatment Emergent Adverse Events (TEAEs)/Serious Adverse Events (SAE) based on standard and systematic assessment including infusion associated reactions (IARs), laboratory test abnormalities, vital signs and ECOG performance status
Anti-tumor activity: Overall response (ORR)
Proportion of patients achieving: stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to International Myeloma Working Group (IMWG 2016) criteria
Anti-Tumor Activity: Duration of response (DOR)
Time from the date of the first determined response to the date of subsequent determined progressive disease or death, whichever happens earlier
Anti-Tumor Activity: Time to progression (TTP)
Time interval from the date of first IMP administration to the date of the first assessed disease progression using IMWG criteria
Anti-Tumor Activity: Progression free survival (PFS)
Time interval from the date of first IMP administration to the date of the first documentation of disease progression or death due to any cause, whichever comes first
Anti-Tumor Activity: Overall survival (OS)
Time interval from the date of first IMP administration to death due to any cause
Immunogenicity
To evaluate the presence of antidrug antibodies (ADA) to isatuximab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03733717
Brief Title
Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma
Official Title
An Open-label, Multi-center Study to Evaluate the Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
September 6, 2020 (Actual)
Study Completion Date
August 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective:
To evaluate the pharmacokinetics (PK) of isatuximab.
Secondary Objectives:
To evaluate the safety and tolerability of isatuximab.
To assess the preliminary antitumor effect of isatuximab.
To evaluate the immunogenicity of isatuximab.
Detailed Description
The duration of the study for an individual patient will include a screening period of up to 21 days, a treatment period of repeated 28-day cycles, and a follow-up period. End of treatment visit will be done at 30 (±7) days after last treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Anti-CD38 monoclonal antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isatuximab
Arm Type
Experimental
Arm Description
Administered intravenously every week in Cycle 1 (4 weeks) followed by every 2 weeks (Q2W) in subsequent cycles.
Intervention Type
Drug
Intervention Name(s)
Isatuximab SAR650984
Other Intervention Name(s)
Sarclisa
Intervention Description
Pharmaceutical form: Concentrate for solution
Route of administration: Intravenous
Primary Outcome Measure Information:
Title
Assessment of PK: Cmax
Description
To evaluate the maximum observed concentration (Cmax)
Time Frame
Cycle 1, up to 168 hours after start of infusion
Title
Assessment of PK: tmax
Description
To evaluate the time to reach Cmax (tmax)
Time Frame
Cycle 1, up to 168 hours after start of infusion
Title
Assessment of PK: AUC0-168h
Description
To evaluate area under the plasma concentration versus time curve over the dosing interval (AUC0-168h)
Time Frame
Cycle 1, up to 168 hours after start of infusion
Title
Assessment of PK: Ceoi
Description
To evaluate the concentration observed at the end of an IV infusion (Ceoi)
Time Frame
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1; Cycle duration is 28 days
Title
Assessment of PK: Ctrough
Description
To evaluate concentration observed just before investigational medicinal product (IMP) administration during repeated dosing (Ctrough)
Time Frame
Up to approximately 40 weeks (Cycle 10)
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Treatment Emergent Adverse Events (TEAEs)/Serious Adverse Events (SAE) based on standard and systematic assessment including infusion associated reactions (IARs), laboratory test abnormalities, vital signs and ECOG performance status
Time Frame
Up to 30 days after the last IMP administration
Title
Anti-tumor activity: Overall response (ORR)
Description
Proportion of patients achieving: stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to International Myeloma Working Group (IMWG 2016) criteria
Time Frame
Up to 12 months after last patient treated
Title
Anti-Tumor Activity: Duration of response (DOR)
Description
Time from the date of the first determined response to the date of subsequent determined progressive disease or death, whichever happens earlier
Time Frame
Up to 12 months after last patient treated
Title
Anti-Tumor Activity: Time to progression (TTP)
Description
Time interval from the date of first IMP administration to the date of the first assessed disease progression using IMWG criteria
Time Frame
Up to 12 months after last patient treated
Title
Anti-Tumor Activity: Progression free survival (PFS)
Description
Time interval from the date of first IMP administration to the date of the first documentation of disease progression or death due to any cause, whichever comes first
Time Frame
Up to 12 months after last patient treated
Title
Anti-Tumor Activity: Overall survival (OS)
Description
Time interval from the date of first IMP administration to death due to any cause
Time Frame
Up to 12 months after last patient treated
Title
Immunogenicity
Description
To evaluate the presence of antidrug antibodies (ADA) to isatuximab
Time Frame
Up to 13 months (10 cycles + 3 months) after last patient treated
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Known diagnosis of symptomatic multiple myeloma.
At least 2 prior lines of therapies which must include treatment with at least 1 of an immunomodulatory drug (IMiD) or a proteasome inhibitor (PI). The patients must have received an IMiD or a PI for ≥2 cycles or ≥2 months of treatment.
Patients must have been responsive to at least 1 prior line of therapy (minimal response or better).
Refractory to the most recently received IMiD or PI included therapy (ie, patients must have progressed during or within 60 days of completion of treatment with IMiD or PI). For patients who have received more than 1 type of IMiD or PI, their disease must be refractory to the most recent one.
Measurable disease defined as at least 1 of the following:
Serum M-protein ≥0.5 g/dL (≥5 g/L);
Urine M-protein ≥200 mg/24 hours.
Written informed consent.
Exclusion criteria:
<18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status >2.
Life expectancy of less than 3 months.
Pretreated with any anticluster of differentiation (CD) 38 agent.
Concurrent plasma cell leukemia.
Known amyloidosis.
Disease measurable only by serum free light chain (FLC) analysis.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 1560003
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Investigational Site Number 1560002
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Investigational Site Number 1560001
City
Tianjin
ZIP/Postal Code
300020
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Learn more about this trial
Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma
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