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Clinical trial · no report yet · Phase 1

NCT02513186

Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
X threads7
YouTube1

The trial

ClinicalTrials.gov
Official title
A Dose Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of SAR650984 (Isatuximab) Administered Intravenously in Combination With Bortezomib - Based Regimens in Adult Patients With Newly Diagnosed Multiple Myeloma Non Eligible for Transplantation or No Intent for Immediate Transplantation
Phase
Phase 1
Status
Completed
Conditions
Plasma Cell Myeloma
Interventions
lenalidomide; bortezomib; cyclophosphamide; dexamethasone; isatuximab SAR650984
Arms
  • Isatuximab · Experimental
Enrollment
90
Primary outcomes
  • Assessment of dose-limiting toxicities (DLTs) in VCDI cohort
  • Overall response rate (VCDI)
  • Complete response rate (VCDI)
  • Complete response rate (VRDI)
Sponsor
Sanofi
Start
Sep 30, 2015
Primary completion
Jan 28, 2022
Results posted
No
Registry record
NCT02513186 · updated Jan 29, 2024

Publications

linked from the registry
  • Ocio EM, Perrot A, Moreau P, Mateos MV, Bringhen S, Martinez-Lopez J, Karlin L, Oprea C, Li Y, Kodas E, San-Miguel J. Plain language summary of a study on 30-minute intravenous infusion of isatuximab in people with newly diagnosed multiple myeloma. Future Oncol. 2026 May;22(11):1235-1246. doi: 10.1080/14796694.2026.2652723. Epub 2026 Apr 27. PubMed 42041169
  • Ocio EM, Perrot A, Bories P, San-Miguel JF, Blau IW, Karlin L, Martinez-Lopez J, Wang SY, Bringhen S, Marcatti M, Mateos MV, Rodriguez-Otero P, Oliva S, Nogai A, Le Roux N, Dong L, Mace S, Gassiot M, Fitzmaurice T, Oprea C, Moreau P. Efficacy and safety of isatuximab plus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma ineligible/with no immediate intent for autologous stem cell transplantation. Leukemia. 2023 Jul;37(7):1521-1529. doi: 10.1038/s41375-023-01936-7. Epub 2023 Jun 14. PubMed 37316728