Clinical trial NCT03733717: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Anti-CD38 monoclonal antibody
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessment of PK: Cmax
timeFrame: Cycle 1, up to 168 hours after start of infusion
measure: Assessment of PK: tmax
timeFrame: Cycle 1, up to 168 hours after start of infusion
measure: Assessment of PK: AUC0-168h
timeFrame: Cycle 1, up to 168 hours after start of infusion
measure: Assessment of PK: Ceoi
timeFrame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1; Cycle duration is 28 days
measure: Assessment of PK: Ctrough
timeFrame: Up to approximately 40 weeks (Cycle 10)
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 30 days after the last IMP administration
measure: Anti-tumor activity: Overall response (ORR)
timeFrame: Up to 12 months after last patient treated
measure: Anti-Tumor Activity: Duration of response (DOR)
timeFrame: Up to 12 months after last patient treated
measure: Anti-Tumor Activity: Time to progression (TTP)
timeFrame: Up to 12 months after last patient treated
measure: Anti-Tumor Activity: Progression free survival (PFS)
timeFrame: Up to 12 months after last patient treated
measure: Anti-Tumor Activity: Overall survival (OS)
timeFrame: Up to 12 months after last patient treated
measure: Immunogenicity
timeFrame: Up to 13 months (10 cycles + 3 months) after last patient treated
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 1560003
city: Nanjing
country: China
facility: Investigational Site Number 1560002
city: Tianjin
country: China
facility: Investigational Site Number 1560001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: