Research project
Myeloma XII (ACCoRd)
- Start date: 20 March 2017
- End date: 31 May 2027
- Value: CRUK and Takeda Pharmaceuticals
- Primary investigator: Professor Gordon Cook
- Co-investigators: Professor David Cairns, Anna Hockaday
- External co-investigators: Professor Walter Gregory (UoL Division of Clinical Trtials Research), Professor Jamie Cavanagh, Professor John Snowden, Professor Kwee Yong, Professor Mark Drayson, Dr John Ashcroft, Dr Mamta Garg, Dr Roger Owen, Dr Ruth DeTute, Dr Christopher Parrish, Dr Kevin Boyd, Dr Mark Cook
Description
Myeloma XII: 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 (ACCoRd)
Introduction
Myeloma XII (also known as ACCoRd) is a clinical trial for patients with multiple myeloma. Multiple myeloma is a cancer of the plasma cells. Plasma cells are white blood cells that are made in the bone marrow and help fight harmful bacteria and viruses in your blood. Patients with myeloma have plasma cells that do not work properly.
Over the past 10 years the treatment for multiple myeloma has developed rapidly and there are many new treatment options available. These new treatments generally keep the myeloma under control (referred to as remission). However, unfortunately for most people their myeloma will return. This is known as relapse of the disease.
When people are first diagnosed, if they are well enough, they will have chemotherapy and an autologous stem cell transplant (ASCT). An ASCT uses healthy blood stem cells from the patient’s own body to replace the diseased or damaged bone marrow. A previous study has shown that although having a second ACST when the disease relapses works, it does not seem to work as well in keeping the myeloma under control as when a stem cell transplant is given at the time of diagnosis.
This trial is intended for people with multiple myeloma who have previously been treated with a stem cell transplant and have experienced a relapse after being disease-free for at least 12 months. The people taking part must be fit and healthy enough to have another stem cell transplant. This trial is still open, but we are no longer recruiting people.
What is the first stage of the trial?
Everyone who enters the trial initially receives treatment with ixazomib, thalidomide and dexamethasone for 4 – 6 cycles of treatment. This stage is called ITD re-induction. Each cycle of treatment lasts 28 days and at the end of every cycle of treatment, a blood test is performed to make sure that trial treatment can continue safely. After ITD re-induction, people who respond well to treatment can move onto the next stage of the trial.
What is the second stage of the trial?
This stage of the trial is called Randomisation 1. Each person is put into a group at random. One group receives the current standard treatment, which is the chemotherapy drug, melphalan and a stem cell transplant. The other group receives an augmented treatment with melphalan and ixazomib and a stem cell transplant. Every person who responds well to this treatment can then move to the next stage of the trial.
What is the third stage of the trial?
This stage of the trial is called Randomisation 2. Each person is put into a group at random. One group receives consolidation and maintenance treatment. The other group is regularly monitored and receives no further treatment which is the current standard of care. People who receive no further treatment are still followed up regularly at their hospital.
The people in the consolidation and maintenance group initially receive 2 cycles of consolidation treatment with ixazomib, thalidomide and dexamethasone. If they continue to respond well to this treatment and are well enough, they can then receive maintenance treatment. On maintenance, people take cycles of ixazomib only. If the disease progresses or if the treatment is not suitable then they withdraw from the trial.
What do we want to find out?
We want to know if adding the targeted cancer chemotherapy drug, ixazomib, alongside the second stem cell transplant at relapse can delay the time it takes for the disease to return. Ixazomib (also called Ninlaro) is like other drugs already used to treat myeloma (e.g., bortezomib), but is a tablet rather than an injection.
We also want to know if adding ixazomib as a treatment after the stem cell transplant helps people with relapsed myeloma when compared with no further treatment.
Impact
Trial Results
It can take many years until all the results are available from a trial. In general, results are often presented at large medical meetings and conferences and are published in scientific journals. This ensures that as many doctors as possible get to know the results. This is how clinical trials can improve treatment and care for patients.
Downloads
If you would like more detailed information on the Myeloma XII trial, the following links may be helpful.
Trial Registry
A clinical trial has to be formally registered on a public database. THIS LINK will take you to the page for the Myeloma trial on ISCRTN.
Protocol Paper
The trial protocol (the instruction manual for people carrying out the trial) was published as an article in a journal. THIS LINK will take you to the online version of the paper.
CRUK Lay Summary
A lay summary of the trial and results is provided on the Cancer Research UK website (CRUK).
Being diagnosed with multiple myeloma can be a particularly stressful time for patients as well as their families and friends. We have included some resources below which you may find helpful.
Cancer Research UK (CRUK) provide research funding and develop evidence-based policy to inform government decisions related to cancer and research, and useful information on clinical trials and supporting information on all types of cancer such as treatment and how to manage the emotional, physical, and practical effects of cancer.
Myeloma UK is a UK charity dedicated to providing support to patients and their families and influencing access to treatment. The charity has an info line 0800 980 3332, where someone can answer your myeloma-related questions and provide emotional support, and also provide ‘Ask the Nurse’ email support and ‘Peer Buddy Service’.
Blood Cancer UK (BCUK) is a UK charity supporting people with all types of blood cancer. The support service nurses can be contacted via phone on 0808 2080888 or e-mail or webform.
If you would like further information about clinical trials, the UK Clinical Research Collaboration (a partnership of organisations working together on clinical research in the UK) and the National Institute for Health Research have published THIS BOOKLET entitled ‘Understanding Clinical Trials’.