NCT04754945

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

Slow-Go Strategy for High Risk AL Amyloidosis: Isatuximab for Upfront Therapy

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: 1. Test the safety and feasibility of isatuximab-based drug treatment. 2. Evaluate the preliminary efficacy of a slow-go approach in high risk AL amyloid patients. STUDY TREATMENT Each patient starts by receiving increasing intensity of treatment for AL Amyloidosis up to maximum tolerance, and then maintenance Isatuximab thereafter for a specified period. All patients will receive Isatuximab (weekly x 4 then every other week) plus dexamethasone 4 mg PO/IV days weekly. If tolerating Isatuximab/Dex4 (earliest time to escalate C1D15), add Velcade to 1 mg/m2 SQ weekly. If tolerating Isa/Vel1.0/Dex4 (earliest time to escalate C2D1), increase dexamethasone to 12 mg weekly. If tolerating Isa/Velcade1.0/Dex12 (earliest time to escalate C3D1), increase Velcade to 1.3 mg/m2 SQ. If tolerating Isa/Velcade1.3/Dex12 (earliest time to escalate C4D1), add cyclophosphamide 300 mg IV weekly. If tolerating Isa/Velcade1.3/Cy300/Dex12 (earliest time to escalate C5D1), increase cyclophosphamide to 400 mg IV weekly. If tolerating Isa/Velcade1.3/Cy400/Dex12 (earliest time to escalate C6D1), increase cyclophosphamide to 500 mg IV weekly. Tolerance determined by the patient not reaching an escalation limiting toxicity AND patient approval to dose escalate. Patients then receive dexamethasone and isatuximab as maintenance treatment twice per month for 12 months in the absence of disease progression or unacceptable toxicity.

Conditions

• AL Amyloidosis

Interventions

Type	Name	Description
DRUG	Bortezomib	Given SC
DRUG	Cyclophosphamide	Given IV or PO
DRUG	Dexamethasone	Given IV or PO
BIOLOGICAL	Isatuximab	Given IV

Timeline

• Start date: 2021-04-28
• Primary completion: 2026-05-06
• Completion: 2026-07-24
• First posted: 2021-02-15
• Last updated: 2026-02-18

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study