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

Sanofi

Status and phase

Completed

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: Isatuximab SAR650984

Study type

Interventional

Funder types

Industry

Identifiers

NCT03733717

TED15085

U1111-1195-6028 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.