ANDROMEDA

ANDROMEDA

A Randomised Phase 3 Study to Evaluate the Safety and Efficacy of Daratumumab in combination with Bortezemib, Cyclophosphamide and Dexamethasone compared with Bortezemib, Cyclophosphamide and Dexamethasone alone in newly diagnosed Systemic AL Amyloidosis.

Disease:

Systemic AL Amyloidosis

Summary:

Amyloidosis is a term given to a group of disorders, characterised by the production of an abnormal protein called amyloid. There are several subtypes, with different triggers and causes. This trial is for patients with the subtype of Systemic AL Amyloidosis.

Plasma cells are part of the body’s immune system, and are responsible for producing antibodies. Systemic AL Amyloidosis occurs when abnormal plasma cells in the bone marrow produce an abnormal antibody protein called light chains. The light chains can build up and be deposited in organs and body tissues as amyloid.

Plasma cells express a cell marker called CD38. Daratumumab is a manufactured antibody that specifically binds to CD38, and leads to reduced activity and death of the targeted plasma cells. It has already been evaluated in patients with other plasma cell disorders, such as Multiple Myeloma, but its benefits are less well known in Systemic AL Amyloidosis.

The aim of the trial is to understand the safety and effectiveness of adding Daratumumab to other established treatments for Systemic AL Amyloidosis.

Eligibility:

Include, but not limited to, the following:

Include, but not limited to, the following;

A new diagnosis of AL Amyloidosis (confirmed on biopsy and blood tests), with one or more organs affected by the condition.

No prior treatment received for Systemic AL Amyloidosis (except a short course of steroids if required)

No symptoms of advanced heart failure.

No other active cancers in the last three years (except for some cancers cured with minor operations such as early skin cancer).

Contact person:

Louise Hay

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

Phone 6457 7600

Principal Investigator:

Dr Brad Auguston

08 6457 7600 (Sir Charles Gairdner Hospital)

Sponsor:

Janssen Australia and New Zealand

Phase:

3

Protocol Number:

54767414AMY3001

Trial Registration Number:

NCT03201965

Clinical Trials.gov

ANZ Clinical Trial Registry