A.R.R.O.W. Study
Research type
Research Study
Full title
A Randomized, Open-label, Phase 3 Study in Subjects with Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination with Dexamethasone, Comparing Once-weekly versus Twice-weekly Carfilzomib Dosing
IRAS ID
178335
Contact name
Margaret Vargo
Contact email
Sponsor organisation
Onyx Therapeutics, Inc.
Eudract number
2014-005325-12
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 71,057
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Patients with multiple myeloma (MM) that has relapsed (returned) or is refractory (nonresponsive to treatment) will be able to join this study and receive treatment with Carfilzomib, an experimental medication.
Carfilzomib is approved in the U.S.A to be used in certain patients but is not approved in the U.K. for any use. In the U.S.A., carfilzomib is approved for use at a specified dose and schedule. This study will evaluate how effective and safe a higher dose of carfilzomib is for treating relapsed or refractory MM given at a higher dose and at a more convenient dosing schedule to the one currently approved for use in the U.S.A.
Enrolled participants will receive carfilzomib in combination with another medication, Dexamethasone. Depending on which treatment group the patient enters, carfilzomib will either be given once weekly at a higher dose in combination with dexamethasone, or at the U.S.A. approved schedule (i.e. twice weekly at the standard dose) in combination with dexamethasone. The effectiveness and safety of these two treatments will then be compared.
Carfilzomib works by preventing the breakdown of abnormal proteins in cells, causing these cells to die. Cancer cells are more sensitive to these effects than normal cells. Dexamethasone is a medicine that is approved for use in the UK for treatment of patients with MM.
About 460 male and female patients aged 18 years or older will join this study at approximately 120 study sites globally. Eligible patients must have had 2 to 3 previous therapies for MM, including treatment with bortezomib and an immunomodulatory medication.
Enrolled participants will receive carfilzomib until their disease worsens, they experience serious side effects, or leave owing to another reason. Participants will come to the clinic for cycles of treatment. Each cycle is 28 days, with a maximum of 7 visits per cycle.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
15/WM/0207
Date of REC Opinion
10 Aug 2015
REC opinion
Further Information Favourable Opinion