54767414MMY3010
Research type
Research Study
Full title
An Open-Label Treatment Use Protocol for Daratumumab in Subjects with Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and an Immunomodulatory Agent) or are Double Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent
IRAS ID
195511
Contact name
Matthew Streetly
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2015-002993-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
This is a non-randomised, single-arm, open-label, multi-centre, treatment use study in participants at least 18 years old with multiple myeloma. Multiple myeloma is a rare type of bone barrow 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, whereby there is an uncontrolled and progressive proliferation of plasma cells which damages the bones and affects the production of healthy blood cells. Treatments for multiple myeloma currently include proteasome inhibitors (PI) and immunomodulatory agents (IMiD), but there remains an unmet need for new treatments for patients that have relapsed following treatment with these classes of drug. Patients who have received at least 3 prior lines of therapy including a PI and an IMiD, or are double refractory to a PI and an IMiD (that is, their multiple myeloma has progressed during or within 60 days of the end of the last cycle of treatment) have no effective treatments and therefore have poor prognostic outcomes. Median overall survival is 9 months for patients refractory to 2 drugs, and 5 months in patients refractory to 3 or 4 drugs, with treatment response decreasing and cumulative toxicity increasing from each additional line of treatment.
This is an early access treatment study that will provide access to daratumumab for this patient population who have received at least 3 prior lines of therapy including a PI and an IMiD, or are double refractory to a PI and an IMiD, and will aim to collect additional safety data whilst the drug is not commercially available.
Daratumumab is a new treatment for multiple myeloma. Daratumumab is different to current treatments in that it binds to CD38, which is a transmembrane glycoprotein that is expressed by the affected plasma cells, and therefore targets the disease in a novel way.
In this study, up to 2000 patients will be treated with daratumumab 16mg/kg via intravenous infusion until disease progression, unacceptable toxicity, lack of clinical benefit, or end of study. The study will be divided into two sections: a screening period and a treatment period. The screening period will be a period of up to 30 days prior to the first dose of daratumumab, followed by the treatment period which will comprise cycles of daratumumab of 28 days.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0457
Date of REC Opinion
24 Dec 2015
REC opinion
Favourable Opinion