Brief Summary
This clinical trial aims to assess the effect of a combination therapy with Venetoclax, Iberdomide and Dexamethasone for the treatment of patients with first or second relapsethe return of disease of Multiple Myeloma t(11;14).
Intervention/Treatment
- Drug: Venetoclax.
- Drug: Iberdomide.
- Drug: Dexamethasone.
Inclusion Criteria:
- Males or females, age 18 years or older, capable of giving consent.
- ECOG performance status of 0 to 2.
- Have confirmed MM as defined by IMWG criteria and have had 1 to 2 prior lines of therapy.
- Have measurable disease defined by having at least one of the following:
- Serum M-protein concentration of greater than or equal to 5g/L.
- Urine M-protein excretion of greater than or equal to 200mg/24 hours.
- Involved serum free light chain (SFLC) greater than or equal to 100mg/L and an abnormal SFLC ratio ( less than 0.26 or greater than 1.65)
- Positive for t(11;14) by fluorescence-in-situ-hybridisation (FISH) testing on bone marrowsoft, spongy tissue found in bones that makes blood cells aspirateto draw out fluid or tissue from the body, often with a syringe sample.
- Adequate bone marrow function.
- Adequate liver function (ALT/AST equal to 2.5 x Upper limit of normal, Bilirubin equal to 1.5 x Upper limit of normal).
- Adequate renal function (creatinine clearance equal to 30ml/minute).
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following applies:
- Is not a woman of childbearing potential (WOCBP) or
- Is a WOCBP and is using a contraceptive method that is highly effective (with failure rate of less than 1%/year) during the study intervention and for at least 4 months after the last dosethe amount of medication taken of the study drug.
- A male participant is eligible to participate if they agree to refrain from donating sperm AND either agree to be abstinent from heterosexual intercourse or agree to use barrier contraception when engaging in sexual activity with a WOCBP (including pregnant females). This female partner must also be using an additional method of highly effective contraceptive method (with failure rate of less than 1%/year).
- Willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments.
- Signed, written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..