C16011

Ixazomib and dexamethasone versus investigator's choice in relapsed AL amyloidosis

A Phase 3 Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physician’s Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

Disease:

AL amyloidosis

Summary:

Amyloids are abnormal proteins that can infiltrate into organs (such as the heart and kidneys) causing damage and dysfunction.

These proteins can be produced by a change in the immune system cells that produce antibodies (plasma cells). This condition is known as systemic AL-amyloidosis. Treatment for AL-amyloidosis can be similar to other plasma cell diseases such as multiple myeloma.

This trial is for patients with AL-amyloidosis who have had treatment previously, and the disease has continued to grow or come back. Patients will have a 50:50 chance of receiving MLN9708 (ixazomib) and dexamethasone (a steroid) or currently used medications for amyloidosis. Ixazomib works by stopping the abnormal plasma cells from multiplying.

The aim of the trial is to see whether ixazomib and dexamethasone is more effective than currently used treatments in AL-amyloidosis.

Eligibility:

Include, but not limited to, the following:

- Patients must be aged 18 years of age or above
- A diagnosis of amyloidosis that has continued to grow (refractory) or returned (relapsed) after 1-2 prior treatments
- No other active cancer (other than some cancers cured with minor operations like skin cancer)
- No other major health problems

Contact person:

Louise Hay

Email louise.hay@health.wa.gov.au

Phone 6457 7600

Principal Investigator:

Dr Bradley Augustson

08 6457 7600

Sponsor:

Millennium Pharmaceuticals

Phase:

III

Protocol Number:

C16011

Trial Registration Number:

NCT01659658

Clinical Trials.gov

ANZ Clinical Trial Registry