Ixazomib Maintenance for AL Amyloidosis

Recruiting in Palo Alto (17 mi)

+8 other locations

Heather J. Landau, MD - MSK Bone Marrow ...

Overseen byHeather Landau, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to learn if Ixazomib maintenance treatment (chemotherapy) works to control the disease. Through this study, the investigators hope to learn more about ways to prevent or delay relapse of AL Amyloidosis.

Eligibility Criteria

This trial is for adults with AL Amyloidosis who've had a partial response to initial therapy, have organ involvement, and are within 12 months of starting treatment. They must not have severe neuropathy or active infections, be pregnant or breastfeeding, or have other recent cancers. Men and women must follow specific contraception guidelines.

Inclusion Criteria

I am 18 years old or older.

I am a woman following specific guidelines regarding menopause, birth control, and pregnancy tests.

My blood tests show significant markers for my disease.

+9 more

Exclusion Criteria

I have a stomach or intestine condition that could affect how I absorb pills.

I am not pregnant or breastfeeding.

My condition did not improve with proteasome inhibitor treatments.

+10 more

Participant Groups

The study tests if Ixazomib can control AL Amyloidosis after initial therapy success. It's given as maintenance chemotherapy to prevent disease relapse. Patients will also receive Dexamethasone as part of the treatment regimen.

1Treatment groups

Experimental Treatment

Group I: ixazomibExperimental Treatment2 Interventions

Enrolled patients will receive ixazomib at a fixed dose of 4mg on days 1, 8, and 15 of a 28-day cycle. Ixazomib will be given orally on days 1, 8, and 15 of a 28 day cycle. Dexamethasone 4mg-12mg will be allowed on days 1, 8, 15 if patients previously tolerated dexamethasone without issue. Treatment cycles will be repeated until disease progression for up to 24 cycles or until development of significant treatment-related toxicities.