Trials / Completed
CompletedNCT03733717
Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Isatuximab SAR650984 | Pharmaceutical form: Concentrate for solution Route of administration: Intravenous |
Timeline
- Start date
- 2018-10-22
- Primary completion
- 2020-09-06
- Completion
- 2023-08-25
- First posted
- 2018-11-07
- Last updated
- 2023-09-08
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03733717. Inclusion in this directory is not an endorsement.