NCT04912427

Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease

A Phase Ib Study of Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib study to assess the safety, tolerability, preliminary efficacy, and renal response of isatuximab, bortezomib, and dexamethasone in newly diagnosed multiple myeloma patients with severe renal impairment or dialysis-dependent end-stage renal disease. Such patients have limited therapeutic options due to renal clearance or nephrotoxicity of many myeloma therapies and are often excluded from clinical trials. Isatuximab in other regimens has shown efficacy and tolerability in patients with moderate renal impairment, although data are lacking for regimens containing CD38-targeting immunotherapies in severe renal impairment/ESRD.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Isatuximab	Isatuximab is supplied by Sanofi.
DRUG	Bortezomib	Bortezomib is commercially available.
DRUG	Dexamethasone	Dexamethasone is commercially available.

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-12-06
• Completion: 2024-01-26
• First posted: 2021-06-03
• Last updated: 2024-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study