Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Daratumumab — BIOLOGICAL
  Given IV
• Dexamethasone — DRUG
  Given IV or PO
• Ixazomib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Feb 7, 2018

Status verified

Feb 2026

Primary completion

May 18, 2027

Completion

May 18, 2027

Study Design

Enrollment

21 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (daratumumab, ixazomib, dexamethasone)
  Participants receive daratumumab 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 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.

Primary Outcome Measure

Dose limiting toxicity rate [ Time Frame: Up to 28 days ]

Locations (1)

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