NCT03499808

S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients With Previously Treated AL Amyloidosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response or better) of isatuximab in relapsed/refractory systemic light chain (AL) amyloidosis. SECONDARY OBJECTIVES: I. To evaluate toxicities in the treatment of relapsed/refractory AL amyloidosis with isatuximab. II. To evaluate time to hematologic response. III. To evaluate duration of response. IV. To evaluate progression-free survival (PFS). V. To evaluate overall survival (OS). TERTIARY OBJECTIVES: I. To evaluate efficacy of isatuximab in relapsed/refractory immunoglobulin amyloid light chain (AL) amyloidosis as measured by organ specific response rates (cardiac, renal, gastrointestinal \[GI\], liver, soft tissue, nerve), in the subset of patients that can be evaluated for organ response. II. To evaluate time to organ response in the subset of patients that can be evaluated for organ response. OUTLINE: Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 30 days and then every at least every 6 months for up to 4 years.

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

Type	Name	Description
BIOLOGICAL	Isatuximab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2018-06-06
• Primary completion: 2023-08-30
• Completion: 2023-09-19
• First posted: 2018-04-17
• Last updated: 2025-09-09
• Results posted: 2025-02-27

Locations

345 sites across 1 country: United States

Regulatory

• FDA-regulated drug study