NCT03283917

Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis

A Safety Study of Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of daratumumab, ixazomib, and dexamethasone in treating participants with amyloid light chain amyloidosis. Monoclonal antibodies, such as daratumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as ixazomib and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab, ixazomib, and dexamethasone may be effective in treating participants with light chain amyloidosis.

Detailed description

PRIMARY OBJECTIVES: I. To confirm the safety and tolerability of daratumumab, ixazomib, and dexamethasone (DId) in patients with amyloid light chain (AL) amyloidosis. II. To determine the recommended phase 2 dose (RP2D) of daratumumab, ixazomib, and dexamethasone in subjects with AL amyloidosis. SECONDARY OBJECTIVES: I. To determine the hematologic response rate of daratumumab, ixazomib, and dexamethasone in patients with AL amyloidosis. II. To determine cardiac and renal organ response rate of daratumumab, ixazomib, and dexamethasone in patients with AL amyloidosis. III. To determine time to next therapy. IV. To determine the time to response. V. To determine the duration of response. VI. To determine progression free survival (PFS). VII. To determine overall survival (OS). OUTLINE: This is a dose-escalation study of dexamethasone. Participants receive daratumumab intravenously (IV) over 3.5-6.5 hours on days 1, 8, 15, and 22 of courses 1-2, on days 1 and 15 of courses 3-6, and on day 1 of courses 7-12. Participants also receive ixazomib orally (PO) on days 1, 8, and 15, and dexamethasone IV over 15 minutes or PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unaccepted toxicity. After completion of study treatment, participants are followed up at 30 days and then every 90 days for 24 months.

Conditions

• Newly Diagnosed Primary Amyloidosis
• Recurrent Primary Amyloidosis
• Refractory Primary Amyloidosis

Interventions

Type	Name	Description
BIOLOGICAL	Daratumumab	Given IV
DRUG	Dexamethasone	Given IV or PO
DRUG	Ixazomib	Given PO

Timeline

• Start date: 2018-02-07
• Primary completion: 2027-05-18
• Completion: 2027-05-18
• First posted: 2017-09-14
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study