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

NCT03733717 | Completed Phase 1

• 2 other identifiers: TED15085U1111-1195-6028
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Myeloma

Keywords

Anti-CD38 monoclonal antibody

Outcome Measures

Primary Outcomes (5)

• Assessment of PK: Cmax

  To evaluate the maximum observed concentration (Cmax)

  Cycle 1, up to 168 hours after start of infusion

• Assessment of PK: tmax

  To evaluate the time to reach Cmax (tmax)

  Cycle 1, up to 168 hours after start of infusion

• 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

• 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

• 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 Outcomes (7)

• Adverse Events

  Up to 30 days after the last IMP administration

• Anti-tumor activity: Overall response (ORR)

  Up to 12 months after last patient treated

• Anti-Tumor Activity: Duration of response (DOR)

  Up to 12 months after last patient treated

• Anti-Tumor Activity: Time to progression (TTP)

  Up to 12 months after last patient treated

• Anti-Tumor Activity: Progression free survival (PFS)

  Up to 12 months after last patient treated

Study Arms (1)

Isatuximab

EXPERIMENTAL

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

Drug: Isatuximab SAR650984

Interventions

Isatuximab SAR650984 DRUG

Pharmaceutical form: Concentrate for solution Route of administration: Intravenous

Also known as: Sarclisa

Isatuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Investigational Site Number 1560003

Beijing, 100191, China

Location

Investigational Site Number 1560002

Nanjing, 210029, China

Location

Investigational Site Number 1560001

Tianjin, 300020, China

Location

Related Publications (1)

• 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.

  PMID: 39528489 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

isatuximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 7, 2018
• Study Start: October 22, 2018
• Primary Completion: September 6, 2020
• Study Completion: August 25, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)