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

NCT04912427 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-02-09

No results posted yet for this study

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

Interventions

DRUG

Isatuximab

Isatuximab is supplied by Sanofi.

DRUG

Bortezomib

Bortezomib is commercially available.

DRUG

Dexamethasone

Dexamethasone is commercially available.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Keith Stockerl-Goldstein, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-12-06
Completion
2024-01-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04912427 on ClinicalTrials.gov