Last updated on February 2019

Study of Daratumumab Ixazomib and Dexamethasone in Previously Treated Amyloid Light Chain (AL) Amyloidosis

Brief description of study

The goal of this clinical research study is to learn if the combination of daratumumab, ixazomib, and dexamethasone at standard doses can be given safely to patients with amyloid light chain (AL) amyloidosis.

Researchers also want to learn the recommended dose of the study drug combination.

This is an investigational study. Daratumumab and ixazomib are FDA approved and commercially available for the treatment of another type of blood cancer called multiple myeloma, although not in combination. Dexamethasone is FDA approved and commercially available to help prevent or treat certain side effects. The combination of daratumumab and ixazomib with dexamethasone is not FDA approved for the treatment of AL amyloidosis. It is currently being used for research purposes only.

The study doctor can explain how the study drugs are designed to work.

Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.

Detailed Study Description

Study Drug Administration:

If participant is found to be eligible to take part in this study, participant will receive daratumumab, ixazomib, and dexamethasone. All participants will receive the study drugs at the same doses. Dexamethasone will be given at a lower dose during Cycle 1 and then a higher dose during Cycles 2 and beyond.

Each cycle is 28 days.

Participant will receive daratumumab by vein on Days 1, 8, 15, and 22 of Cycles 1-2, then on Days 1 and 15 for Cycles 3-6, and on Day 1 of Cycles 7-12. The first 2 doses will be given over 6 hours. After that, the doses may be given over 3 hours if participant has no bad reactions.

Participant will take ixazomib by mouth on Days 1, 8, and 15 of Cycles 1-12. Participant should take each dose of ixazomib on an empty stomach (no food or drink) at least 1 hour before or at least 2 hours after food, with about 8 ounces (1 cup) of water.

Swallow the ixazomib capsules whole. Do not break, chew, or open capsules. If participant misses or vomits a dose of study drug at home, participant should not retake the missed or vomited dose. Participant should wait and take the next scheduled dose.

Dexamethasone is given as a premedication before participant's dose of daratumumab to lower the risk of side effects. Participant will receive dexamethasone by vein over 15 minutes or by mouth on Days 1, 8, 15, and 22 of Cycle 1. Starting with Cycle 2 and beyond, dexamethasone will be given as a premedication before each dose of daratumumab and then again the next day. During weeks when participant does not have a daratumumab dose scheduled, participant will receive dexamethasone as a single dose 1 time a week.

Participant will be given other standard drugs to help decrease the risk of side effects, such as infection and indigestion. Participant may ask the study staff for information about how the drugs are given and their risks.

Participant should bring any empty bottles and any unused study drug to the clinic at each visit. Participant will be given a diary to record when participant takes participant's study drug each day.

Study Visits:

On Day 1 of Cycles 1-12:

  • Participant will have a physical exam.
  • Blood (about 4 tablespoons) will be drawn and a 24-hour urine sample will be collected for routine tests.

On Day 8, 15, and 22 of Cycles 1 and 2 and Day 15 of Cycle 3-6, blood (about 1-2 tablespoons) will be drawn for routine tests.

These tests may be repeated if the doctor thinks it is needed.

Length of Study:

Participant may continue taking the study drugs for up to 12 cycles, as long as the doctor thinks it is in participant's best interest. Participant will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.

Participation on the study will be over after participant's last follow-up visit.

Follow-up Visits:

About 30 days after participant's last study drug dose:

  • Participant will have a physical exam.
  • Blood (about 4 tablespoons) will be drawn and a 24-hour urine sample will be collected for routine tests.
  • Participant will have an ECHO to check participant's heart function.

If participant stops the study drugs and the disease has not gotten worse, blood (about 4 tablespoons) will be drawn and a 24-hour urine sample will be collected for routine tests every 90 days (+/- 30 days). The testing will stop after 24 months or if the disease gets worse, whichever comes first.

Clinical Study Identifier: NCT03283917

Contact Investigators or Research Sites near you

Start Over

Hans C. Lee, MD

University of Texas MD Anderson Cancer Center
Houston, TX United States
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Recruitment Status: Open

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