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

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Isatuximab SAR650984

• Registration Number: NCT03733717
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2018-10-22
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-07
• Primary Completion: 2020-09-06
• Study Completion: 2023-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Isatuximab	Isatuximab SAR650984	Administered intravenously every week in Cycle 1 (4 weeks) followed by every 2 weeks (Q2W) in subsequent cycles.

Primary Outcome Measures

Name	Time	Method
Assessment of PK: Ctrough	Up to approximately 40 weeks (Cycle 10)	To evaluate concentration observed just before investigational medicinal product (IMP) administration during repeated dosing (Ctrough)
Assessment of PK: Cmax	Cycle 1, up to 168 hours after start of infusion	To evaluate the maximum observed concentration (Cmax)
Assessment of PK: tmax	Cycle 1, up to 168 hours after start of infusion	To evaluate the time to reach Cmax (tmax)
Assessment of PK: AUC0-168h	Cycle 1, up to 168 hours after start of infusion	To evaluate area under the plasma concentration versus time curve over the dosing interval (AUC0-168h)
Assessment of PK: Ceoi	Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1; Cycle duration is 28 days	To evaluate the concentration observed at the end of an IV infusion (Ceoi)

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Up to 30 days after the last IMP administration	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 survival (OS)	Up to 12 months after last patient treated	Time interval from the date of first IMP administration to death due to any cause
Anti-Tumor Activity: Duration of response (DOR)	Up to 12 months after last patient treated	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)	Up to 12 months after last patient treated	Time interval from the date of first IMP administration to the date of the first assessed disease progression using IMWG criteria
Immunogenicity	Up to 13 months (10 cycles + 3 months) after last patient treated	To evaluate the presence of antidrug antibodies (ADA) to isatuximab
Anti-tumor activity: Overall response (ORR)	Up to 12 months after last patient treated	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: Progression free survival (PFS)	Up to 12 months after last patient treated	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

Trial Locations

Locations (3)

Investigational Site Number 1560003; 🇨🇳 Beijing, China

Investigational Site Number 1560001; 🇨🇳 Tianjin, China

Investigational Site Number 1560002; 🇨🇳 Nanjing, China