Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733717
• Other study ID #: TED15085
• Secondary ID: U1111-1195-6028
• Status: Completed
• Phase: Phase 1
• Start date: October 22, 2018
• Est. completion date: August 25, 2023

Study information

• Verified date: September 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 25, 2023
• Est. primary completion date: September 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Isatuximab SAR650984
Pharmaceutical form: Concentrate for solution Route of administration: Intravenous

Locations

Country	Name	City	State
China	Investigational Site Number 1560003	Beijing
China	Investigational Site Number 1560002	Nanjing
China	Investigational Site Number 1560001	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of PK: Cmax	To evaluate the maximum observed concentration (Cmax)	Cycle 1, up to 168 hours after start of infusion
Primary	Assessment of PK: tmax	To evaluate the time to reach Cmax (tmax)	Cycle 1, up to 168 hours after start of infusion
Primary	Assessment of PK: AUC0-168h	To evaluate area under the plasma concentration versus time curve over the dosing interval (AUC0-168h)	Cycle 1, up to 168 hours after start of infusion
Primary	Assessment of PK: Ceoi	To evaluate the concentration observed at the end of an IV infusion (Ceoi)	Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1; Cycle duration is 28 days
Primary	Assessment of PK: Ctrough	To evaluate concentration observed just before investigational medicinal product (IMP) administration during repeated dosing (Ctrough)	Up to approximately 40 weeks (Cycle 10)
Secondary	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	Up to 30 days after the last IMP administration
Secondary	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	Up to 12 months after last patient treated
Secondary	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	Up to 12 months after last patient treated
Secondary	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	Up to 12 months after last patient treated
Secondary	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	Up to 12 months after last patient treated
Secondary	Anti-Tumor Activity: Overall survival (OS)	Time interval from the date of first IMP administration to death due to any cause	Up to 12 months after last patient treated
Secondary	Immunogenicity	To evaluate the presence of antidrug antibodies (ADA) to isatuximab	Up to 13 months (10 cycles + 3 months) after last patient treated