COLUMBA
Research type
Research Study
Full title
A phase 3, randomised, multicentre study of subcutaneous vs intravenous administration of daratumumab in subjects with relapsed or refractory multiple myeloma
IRAS ID
233852
Contact name
Matthew Streetly
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2017-000206-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
This is a research study in 480 adults with multiple myeloma. Multiple myeloma is a rare type of bone marrow cancer that can be controlled by some current treatments, but there is currently no cure. Multiple myeloma affects the plasma cells inside the bone marrow, causing these to grow out of control. This damages the bones and affects the production of healthy blood cells. Treatments for multiple myeloma currently include combination chemotherapy, proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs), high-dose chemotherapy, and stem cell support.
This study will involve patients who have multiple myeloma that is resistant to treatment. They will have received at least 3 prior lines of therapy including a PI and a IMiD, or have disease which does not respond to both a PI and a IMiD.
The study will use a medication for multiple myeloma called daratumumab. This medication (also known as Darzalex in the UK) is currently approved for use when given to patients in liquid form directly into a vein (intravenously). The 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 how well daratumumab works when given subcutaneously, as compared to intravenously. The benefits of giving daratumumab subcutaneously would include the potential for fewer infusion-related reactions, shorter administration time, and reduced volume of medication.
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 comprise 28 day cycles of daratumumab – half of the patients will receive daratumumab subcutaneously, and half will receive daratumumab intravenously. Follow-up will continue until the end of the study.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0345
Date of REC Opinion
11 Oct 2017
REC opinion
Favourable Opinion