Subcut Daratumumab in combination with standard treatment regimens
Research type
Research Study
Full title
A multicentre phase 2 study to evaluate subcutaneous daratumumab in combination with standard multiple myeloma treatment regimens
IRAS ID
241440
Contact name
Helen McCarthy
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2017-004203-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 7 days
Research summary
This is a research study in 180 adults with multiple myeloma (MM). MM is a rare and life-threating type of bone cancer, which can be controlled by some treatments although there is currently no cure. MM affects the plasma cells in bone marrow, causing these to grow out of control. Daratumumab (also known as Darzalex in the UK) is a new treatment for MM which binds to a substance expressed by affected plasma cells, and so targets the disease in a novel way.
The purpose of the study is to find out if daratumumab (when administered through an injection under the skin) in combination with standard treatment regimens is effective and safe.
The study will involve 3 different groups of MM patients – those with newly diagnosed MM who are transplant eligible, those with newly diagnosed MM who are not eligible for transplant, and those with relapsed or refractory MM (patients who do not respond to treatment, or initially respond but do not respond after disease worsens). Each group will receive daratumumab together with combinations of medicines which are standard care.
The 3 cohorts are known as D-VRd (daratumumab + bortezomib (Velcade) + lenalidomide (Revlimid) + dexamethasone), D-VMP (daratumumab + bortezomib + melphalan + prednisone), and D-Rd (daratumumab + lenalidomide + dexamethasone).
The study is conducted in 3 phases: screening, treatment and follow-up. Screening will last up to 28 days, to check whether the patient is eligible, and follow-up will involve an end of treatment visit, and a visit 8 weeks after the last dose of daratumumab. The treatment period differs between groups: 4x 21-day cycles for D-VRd, 9x 42-day cycles followed by 28-day cycles until disease progression for D-VMP, and 28-day cycles until disease progression for D-Rd. Total length of involvement for patients will be 7 – 8 months (D-VRd) or up to 2.5 years (D-VMP and D-Rd).
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0098
Date of REC Opinion
13 Mar 2018
REC opinion
Favourable Opinion