VIBER-M: This study aims to assess the effect of a combination therapy with Venetoclax, Iberdomide and Dexamethasone for the treatment of patients with first or second relapse of Multiple Myeloma t(11;14)A phase 1b/II study of the efficacy of Venetoclax, Iberdomide and Dexamethasone (IberVenD) for patients in first or second relapse of Multiple Myeloma with t(11;14)

Exclusion

1. Previous treatment with Bcl-2 inhibitor or CELMod
2. Any of the following conditions: Non-secretory Multiple Myeloma, solitary plasmacytoma or plasma cell leukaemia.
3. Known Central nervous system involvement
4. Systemic anti-myeloma therapy within less than or equal to 14 days with the exception of corticosteroids equivalent to dexamethasone less than or equal to 160mg in total within last 4 weeks.
5. Major surgery within 14 days of initiating study treatment
6. Radiotherapy within 14 days of initiating study treatment
7. Female patients who are lactating or have a positive serum pregnancy test during screening period.
8. Evidence of cardiovascular risk:
o Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block;
o History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, or stenting or bypass grafting within the last 6 months;
o Class III of IV heart failure defined by New York Heart Association functional classification system
9. Known immediate or delayed hypersensitivity or allergy to previous drugs chemically related to venetoclax and/or Iberdomide.
10. Acute infections requiring antibiotic, antifungal or antiviral therapy within 1 week prior to first dose.
11. Known HIV infection.
12. Hepatitis B surface antigen positivity or Hepatitis B DNA positivity at screening or within 3 months prior to first dose of study treatment. Participants with positive Hepatitis B core antibody testing can be enrolled if Hepatitis B DNA negative and receiving Hepatitis B prophylaxis.
13. Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance of iberdomide or venetoclax.
14. Use of a strong or moderate CYP3A inhibitor or inducer within 1 week prior to starting first dose of study treatment.
15. Diagnosed or treated for another malignancy within 2 years before study enrolment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
16. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.