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RecruitingLast updated: 1 March 2024

Riddle-M-X: The purpose of this study is to improve treatment for people with newly diagnosed multiple myeloma who undergo autologous stem cell treatment by using diagnostic techniques to guide whether a drug called Selinexor should be added to standard careInvestigating the efficacy of Risk Directed front-line therapy for Multiple Myeloma incorporating Selinexor: The RIDDLE-M-X trial

Clinical summary

Summary

All participants who enrol in this study will have a bone marrow sample taken and assessed to determine whether they are have high risk or standard risk disease. These details will then be used to allocate participants for 'induction' therapy, to either standard of care treatment (consisting of bortezomib, lenalidomide and dexamethasone), or standard of care treatment with added selinexor.

This is a risk-adaptive approach to treatment, meaning your treatment is guided by the results of your myeloma risk profile. Participants will continue with their allocated treatments for 4-5 months. After this time, all participants will then undergo preparation for an autologous stem cell transplant, where healthy stem cells will be harvested from each participant and expanded externally, before being re-implanted back to stimulate further stem cell growth.

At 5-6 months after the transplant, all participants will be required to provide a second bone marrow sample to undergo a second test to check how they are responding to treatment and assess if there is a very small but detectable number of myeloma cells.

For standard risk patients, if there isn't any detectable myeloma cells, you will continue treatment with only lenalidomide. If there are detectable cells, you will be given lenalidomide and selinexor. High-risk patients will be given lenalidomide and selinexor regardless of the results. This is called 'maintenance' therapy.

Participants will then continue taking their second allocation of medications for maintenance until the treatments are no longer effective. This could range from months to years. Further bone marrow samples will be required at 6 and 12 months after commencing maintenance treatment to test for detectable myeloma cells. The trial is intended to run over 4-5 years.

You will be asked to complete short questionnaires about your multiple myeloma treatment and your health-related quality of life every month prior to the transplant, and about 4-5 months after the transplant and within 12 months after commencing maintenance therapy.

Conditions

This trial is treating patients with newly diagnosed multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

Riddle-M-X

More information

Trial Identifiers

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Trial sponsor

Australasian Myeloma Research Consortium

Scientific Title

Investigating the efficacy of Risk Directed front-line therapy for Multiple Myeloma incorporating Selinexor: The RIDDLE-M-X trial

Eligibility

Inclusion

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.

Exclusion

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.

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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