Investigating the efficacy of Risk Directed front-line therapy for Multiple Myeloma incorporating Selinexor: The RIDDLE-M-X trial
Multiple Myeloma
To assess the efficacy of the incorporation of selinexor into standard of care therapy in high-risk newly diagnosed MM.
Key inclusion criteria:
1. Male and Female patients, 18 years of age or older
2. Able to provide written consent.
3. Newly diagnosed MM as per IMWG criteria eligible for ASCT.
4. Diagnostic bone marrow sample available for SKY92 risk analysis.
5. Measurable disease as defined by any of the following
o Serum M-component >5 g/L, and/or
o Urine M-component > 200 mg/24 h, and/or
o Involved serum FLC level >100mg/L.
6. No contraindication to the use of any of the study drugs and able to comply with trial requirements.
7. Adequate liver function (total bilirubin < 2.0x ULN, ALT < 5.0x ULN) unless considered secondary to MM.
8. Absolute neutrophil count >= 1.0 x 109/L.
9. Platelet count >= 50 x 109/L (>= 30 x 109/L if MM involvement in the marrow is greater than 50%), patients should not have received platelet transfusions within 7 days of the screening platelet count.
10. Hb >= 80g/L, red cell transfusions as per institutional protocol are allowed.
11. Woman of childbearing potential must agree to ongoing pregnancy testing, to be performed within 72 hours before during treatment and on day 28 after last dose of study treatment.
12. Women of childbearing potential must agree to use one highly effective method and preferably one additional effective (barrier) method during the study and for 28 days following the last dose of study treatment.
13. Male participants who are sexually active with WOCBP must use a condom during sexual contact during study and for at least 7 days after last dose of study treatment.
14. Male participants must not donate sperm during study and for at least 7 days after last dose of study treatment.
Key exclusion criteria:
1. Patients who have had myocardial infarction within 6 months prior to enrolment, or New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
2. Any other serious or uncontrolled medical or psychiatric illness that could, in the investigators’ opinion, potentially interfere with the completion of treatment according to this protocol.
3. Known ongoing or active systemic infection, active hepatitis B or C infection, or known human immunodeficiency positivity.
4. Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine pregnancy test at Screening.
5. Any patient who is unable or unwilling to meet the requirements of the lenalidomide pregnancy prevention programme.
6. Active malignancy with the exception of any of the following:
o Adequately treated basal cell carcinoma, squamous cell carcinoma or in situ cervical cancer.
o Adequately treated stage 1 cancer from which the subject is currently in remission from and has been in remission for > 2 years.
o Stage 1 prostate cancer that does not require treatment.
o Any other cancer from which the subject has been disease-free for > 2 years.
7. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
Dr. Katharine Lewis
Australasian Myeloma Research Consortium
Phase 2
AMaRC 21-04
ACTRN12622001366741