Myeloma XII (ACCoRd trial) Version 1.0
Research type
Research Study
Full title
A phase III study to determine the role of ixazomib as an Augmented Conditioning therapy in salvage autologous stem cell transplant (ASCT) and as a post-ASCT Consolidation and maintenance strategy in patients with Relapsed multiple myeloma.
IRAS ID
188554
Contact name
Gordon Cook
Contact email
Sponsor organisation
University of Leeds
Eudract number
2016-000905-35
Duration of Study in the UK
9 years, 6 months, 0 days
Research summary
Background: Multiple myeloma (MM) is a blood cancer with approximately 4500 new cases in the UK each year. Treatment for MM has changed in the last decade with the arrival of new drugs such as proteasome inhibitors and immunomodulatory drugs (IMiDs). These new drugs have been shown to improve response rate and duration of response in second-line treatment (second treatment for patients whose MM has deteriorated since their first treatment). \n\nThe Myeloma X study showed that an autologous stem cell transplant (ASCT) (using the patient’s own stem cells) as part of second-line treatment prolongs progression free survival (PFS) following chemotherapy containing a proteasome inhibitor (known as re-induction therapy). Consequently, the number of second ASCTs performed in the UK has risen and is now recommended (for suitable patients) by the International Myeloma Working Group. However, the Myeloma X study showed that depth and duration of response in second-line ASCT, was less than that of first-line ASCT. Hence, this study will investigate whether depth and duration of response can be improved by the addition of a proteasome inhibitor called ixazomib to melphalan conditioning, consolidation and maintenance treatment.\n\nAims: This trial aims to determine and compare: \na) The depth of response between standard melphalan conditioning and augmented (adding ixazomib) melphalan conditioning at second ASCT. \nb) The impact of adding consolidation and maintenance treatment versus no further treatment, on progression free survival.\n\nMethods: This is a phase III, randomised, controlled, multi-centre, open-label trial with a single intervention registration stage and two randomisations. The first randomisation will be between augmented ASCT and standard ASCT. The primary end-point is to assess improvement in depth of response. The second randomisation will be between consolidation and maintenance treatment versus no further treatment. The primary end-point being to assess the duration of response as determined by PFS.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0517
Date of REC Opinion
24 Aug 2016
REC opinion
Further Information Favourable Opinion