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

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Unknown Primary	NCT ID:	NCT04754945
Trial Phases:	Phase I	Protocol IDs:	Winship5086-20 (primary) NCI-2020-06548
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04754945

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.

Objectives

PRIMARY OBJECTIVES:
I. Test the safety and feasibility of isatuximab-based drug treatment.
II. Evaluate the preliminary efficacy of a slow-go approach in high risk AL amyloid patients.

OUTLINE:
Patients receive dexamethasone intravenously (IV) or orally (PO) and isatuximab IV over 3 hours and 20 minutes for the first dose, over 1 hour and 53 minutes for the second dose, and over 75 minutes for subsequent doses. Treatment repeats weekly for 4 weeks and then every other week thereafter for up to 196 days. Beginning day 15, patients receive bortezomib subcutaneously (SC) weekly for 182 days and beginning day 85, patients receive cyclophosphamide IV or PO weekly for 112 days. Patients then receive dexamethasone and isatuximab as maintenance treatment twice per month for 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks. Patient records are reviewed for 2 years from enrollment.

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