Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01749969 · ClinicalTrials.gov registry record · Phase 1
SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT01749969 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 57 participants.
The verdict
NCT01749969, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
Primary Objectives: * To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and dexamethasone (LD) in patients with relapsed or refractory multiple myeloma. * Expansion Phase Only: To further evaluate preliminary evidence of antitumor activity (objective response rate \[ORR\]) of SAR650984 (isatuximab) in combination with LD using International Myeloma Working Group (IMWG) criteria. Secondary Objectives: * To evaluate the safety, including immunogenicity, of SAR650984 (isatuximab) in combination with LD in relapsed or refractory multiple myeloma. The severity, frequency and incidence of all toxicities will be assessed. * To evaluate the pharmacokinetics (PK) of SAR650984 (isatuximab) when administered in combination with LD and the PK of lenalidomide in combination with SAR650984 and dexamethasone. * To assess the relationship between clinical (adverse event \[AE\] and/or tumor response) effects and pharmacologic parameters (PK/pharmacodynamics), and/or biologic (correlative laboratory) results. * For the dose expansion phase, estimate the activity (ORR) using IMWG defined response criteria of SAR650984 (isatuximab) plus LD. * To describe progression-free survival (PFS) in patients treated with this combination.
Interventions
- DRUG dexamethasone
- DRUG lenalidomide
- DRUG isatuximab SAR650984
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2013-02-06 |
| Est. Completion | 2023-06-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01749969
The ClinicalTrials.gov registry entry for NCT01749969 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which dexamethasone is the first listed.
NCT01749969 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01749969 about?
NCT01749969 is a clinical study titled "SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients". Primary Objectives: * To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and dexamethasone (LD) in patients with relapsed or refractory multiple myeloma. * Expansion Phase Only: To further evaluate preliminary evidence of antitumor activity (objective response rate ...
What is the current status of trial NCT01749969?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2013-02-06. Estimated completion is 2023-06-20.
What interventions are being tested in trial NCT01749969?
The interventions under investigation include: dexamethasone (DRUG), lenalidomide (DRUG), isatuximab SAR650984 (DRUG).
Who is sponsoring clinical trial NCT01749969?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.