Multiple Myeloma (MM) remains a high-burden, high-cost and incurable disease, where current available therapies on the PBS are relatively ineffective against high-risk newly-diagnosed MM. Patients with high-risk MM have genetic profiles that make the treatment of MM more challenging, resulting in poorer health outcomes.
There is also evidence that treating MM patients to achieve their best response possible and reduce the number of detectable myeloma cells leads to better health outcomes.
Selinexor is part of a group of drugs known as 'selective inhibitors of nuclear export'. Selinexor works by blocking the action of a protein called XPO1 in myeloma cells. This blocks the transport of several proteins involved in cancer cell growth, which ultimately leads to myeloma cell death. There is evidence to show that selinexor is more effective than the existing PBS treatments for MM.
The RIDDLE-M-X trial will utilise a risk and response adaptation approach to treat newly-diagnosed MM patients undergoing autologous stem cell transplantation (ASCT). We plan to use a diagnosic proceture known as SKY92 MMProfiler to pre-screen participants to determine their MM genetic risk category in real time. We will also use another diagnostic technique called EuroFlow after ASCT to determine a parameter called minimal residual disease (MRD), which is based on the number of detectable myeloma cells. Selinexor will be added to standard PBS therapy in patients who either: 1) are categorised to have high-risk myeloma based on the SKY92 MMProfiler test, or 2) have a significant number of detectable myeloma cells (MRD positive) based on the EuroFlow test.
STATUS
Actively Recruiting
CURRENT ENROLMENT
43 Patients
Recruitment updated as of December 2024
STUDY DESIGN
A multicentre, phase II, risk and response stratified, open label trial
CORRELATIVE STUDIES
Blood, bone marrow, and saliva samples will be collected as part of the trial to assess the immunological, epigenetics and molecular profile.
TRIAL PRINCIPAL INVESTIGATORS
Professor Andrew Spencer, Dr Sueh-li Lim
TIME FRAME
2023-2028
PARTICIPANTS
Newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant
SITE LOCATIONS
- Alfred Hospital, VIC
- Nepean Hospital, NSW
- Northern Hospital, VIC
- Royal Prince Alfred Hospital, NSW
- Sunshine Coast University Hospital, QLD
- Royal Brisbane and Women's Hospital, QLD
- Latrobe Regional Hospital, VIC
- Sir Charles Gairdner Hospital, WA
- Box Hill Hospital, VIC
- Canberra Hospital, ACT