ANDROMEDA (54767414AMY3001)
Research type
Research Study
Full title
ANDROMEDA: A randomised phase 3 study to evaluate the efficacy and safety of daratumumab in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in newly diagnosed systemic AL amyloidosis
IRAS ID
239889
Contact name
Ashutosh Wechalekar
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2016-001737-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
This is a research study in 370 patients with newly diagnosed systemic amyloid light chain (AL) amyloidosis. AL amyloidosis is a type of cancer which affects the plasma cells inside bone marrow, causing these to produce abnormal forms of light chain proteins. These proteins can enter the bloodstream and form amyloid deposits that can lead to organ failure.
AL amyloidosis has a poor prognosis, with a 13-month median survival for untreated patients from diagnosis. There is no cure, but treatments can help to eradicate the plasma cells which produce the proteins that form amyloid deposits. Treatment for AL amyloidosis is taken directly from experience of treating a different but similar disease called multiple myeloma (MM). Patients with AL amyloidosis are commonly treated with three medications collectively known as CyBorD (cyclophosphamide, bortezomib (also known as Velcade in the UK) and dexamethasone).
Half of the participants will receive treatment with CyBorD, and half will receive treatment with CyBorD plus a medication called daratumumab. This medication (also known as Darzalex in the UK) is currently approved for use when given to patients with MM in liquid form directly into a vein (intravenously). This study will use a new way to give daratumumab, which is called subcutaneous injection (given in liquid form under the skin).
The purpose of the study is to evaluate whether daratumumab when given with CyBorD is useful for treating patients with AL amyloidosis. The study will look at what happens (good and bad) when daratumumab is given with CyBorD compared to just CyBorD alone.
The study is conducted in four phases: screening, treatment, post-treatment observation, and long-term follow-up. Participation in the study will last up to six years. Participants will receive six months of CyBorD treatment, and half of the participants will also receive up to two years of daratumumab.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/1156
Date of REC Opinion
8 Oct 2018
REC opinion
Further Information Favourable Opinion