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Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis

NCT04754945 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-02-18

No results posted yet for this study

Summary

This phase I trial studies the side effects of isatuximab and to see how well it works in treating patients with high risk immunoglobulin light chain amyloidosis (AL amyloidosis). Isatuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.

Conditions

  • AL Amyloidosis

Interventions

DRUG

Bortezomib

Given SC

DRUG

Cyclophosphamide

Given IV or PO

DRUG

Dexamethasone

Given IV or PO

BIOLOGICAL

Isatuximab

Given IV

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Craig C Hofmeister, MD, MPH · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2026-05-06
Completion
2026-07-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT04754945 on ClinicalTrials.gov