AQUILA (54767414SMM3001)
Research type
Research Study
Full title
A phase 3, randomised, multicentre study of subcutaneous daratumumab versus active monitoring in subjects with high-risk smouldering multiple myeloma
IRAS ID
233853
Contact name
Jindriska Lindsay
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2016-001205-16
Duration of Study in the UK
8 years, 0 months, 1 days
Research summary
This is a research study in 360 adults with smouldering multiple myeloma (SMM). SMM is an early stage cancer of the bone marrow, which eventually turns into multiple myeloma (MM) in most patients. MM is a life-threatening cancer which affects the plasma cells in bone marrow, causing these to grow out of control. This causes damage to the bones and organs. Standard care for patients with SMM is currently observation (active monitoring without treatment).
The study will involve patients with high-risk SMM; these patients do not currently feel any symptoms related to their disease (pre-symptomatic).
When patients are diagnosed with SMM, it is not known whether they should have a period of observation, or receive treatment immediately. The purpose of the study is to find out if it is better for patients to receive treatment when diagnosed with SMM, or to have a period of observation until diagnosed with MM. Both observation and treatment aim to prevent bone and organ damage.
Half of the participants will receive observation, and half will receive treatment. Those in the treatment group will receive a medication for MM called daratumumab. This medication (also known as Darzalex in the UK) is currently approved for use in patients with MM when given to patients in liquid form directly into a vein (intravenously). The study will use daratumumab for the treatment for SMM and give daratumumab in a new way, by subcutaneous injection (given in liquid form under the skin).
The study is conducted in three phases: screening, treatment and follow-up. Screening will last up to four weeks, to check whether the patient is eligible. Treatment period will last up to 36 months, comprising either observation or 39 cycles (28 days each) of daratumumab. Follow-up will continue until the end of the study.
REC name
East of England - Essex Research Ethics Committee
REC reference
17/EE/0437
Date of REC Opinion
27 Nov 2017
REC opinion
Further Information Favourable Opinion