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

NCT ID: NCT03733717

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-22
• Study Completion Date: 2023-08-25

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Isatuximab

Administered intravenously every week in Cycle 1 (4 weeks) followed by every 2 weeks (Q2W) in subsequent cycles.

Group Type: EXPERIMENTAL

Isatuximab SAR650984

Intervention Type: DRUG

Pharmaceutical form: Concentrate for solution

Route of administration: Intravenous

Interventions

Isatuximab SAR650984

Pharmaceutical form: Concentrate for solution

Route of administration: Intravenous

Intervention Type: DRUG

Other Intervention Names

Sarclisa

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 1560003

Beijing, , China

Investigational Site Number 1560002

Nanjing, , China

Investigational Site Number 1560001

Tianjin, , China

Countries

China

References

Sun M, Jing H, Qu X, Dong F, Li Y, Feng Z, Ziti-Ljajic S, Semiond D, Li L, Qi J, Qiu L. Phase 1 study of isatuximab monotherapy in Chinese patients with relapsed/refractory multiple myeloma. Sci Rep. 2024 Nov 11;14(1):27550. doi: 10.1038/s41598-024-59186-1.

Reference Type: DERIVED

PMID: 39528489 (View on PubMed)

Other Identifiers

U1111-1195-6028

Identifier Type: OTHER

Identifier Source: secondary_id

TED15085

Identifier Type: -

Identifier Source: org_study_id