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S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

NCT03499808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-09-09

Study results available
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Summary

This phase II trial studies how well isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.

Conditions

  • Amorphous, Eosinophilic, and Acellular Deposit
  • Constipation
  • Diarrhea
  • Early Satiety
  • Gastrointestinal Hemorrhage
  • Hepatomegaly
  • Lymphadenopathy
  • Macroglossia
  • Nausea
  • Primary Systemic Amyloidosis
  • Purpura
  • Recurrent Primary Amyloidosis
  • Refractory Primary Amyloidosis

Interventions

BIOLOGICAL

Isatuximab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Emma Scott · SWOG Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-06
Primary Completion
2023-08-30
Completion
2023-09-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03499808 on ClinicalTrials.gov