Daratumumab + Ixazomib + Dexamethasone for Amyloidosis

Recruiting in Palo Alto (17 mi)

Overseen byHans Lee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Hans Lee, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with AL amyloidosis, a condition where abnormal proteins build up in organs. Participants must have an acceptable level of organ function and performance status, not be pregnant or breastfeeding, and agree to use contraception. Those with severe infections, recent major surgeries or treatments, certain other cancers within the last 2 years, or specific heart diseases cannot join.

Inclusion Criteria

I agree to use contraception as required.

I am a woman who is postmenopausal, surgically sterile, or agrees to use contraception.

I have been diagnosed with AL amyloidosis confirmed by specific tests.

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Exclusion Criteria

My condition is not light-chain (AL) amyloidosis.

My lung function is severely reduced, with less than half the normal airflow.

Participation in other clinical trials within 30 days of the start of this trial and throughout its duration

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Treatment Details

Interventions

Daratumumab (Monoclonal Antibodies)
Dexamethasone (Corticosteroid)
Ixazomib (Proteasome Inhibitor)

Trial OverviewThe study tests the combination of daratumumab (a monoclonal antibody), ixazomib (chemotherapy), and dexamethasone (a steroid) to treat AL amyloidosis. It aims to find the safest doses and see how well they work together against this disease by stopping tumor cells from growing.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (daratumumab, ixazomib, dexamethasone)Experimental Treatment3 Interventions

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.