Testing Iberdomide with Bortezomib for multiple myeloma

Exclusion

• −Patients with hypersensitivity to boron or any of its excipients or to the active substance of Iberdomide or its excipients
• −Known HIV positivity or active infectious hepatitis, type A, B, or C.
• −Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \[i.e. less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of treatment start\]).
• −Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
• −Renal failure requiring hemodialysis or peritoneal dialysis.
• −Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
• −Basal cell carcinoma of the skin
• −Squamous cell carcinoma of the skin
• −Carcinoma in situ of the cervix
• −Carcinoma in situ of the breast
• −Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
• −Patients who are unable or unwilling to undergo antithrombotic therapy.
• −Peripheral neuropathy of ≥ grade 2 severity.
• −Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
• −Plasma Cell Leukemia
• −Evidence of cardiovascular risk including any of the following:
• −QTc interval ≥ 470 msecs. Note that the QT interval should be corrected for heart rate by Fridericia's formula (QTcF)
• −Evidence of current clinically significant uncontrolled arrhythmias; including clinically significant ECG abnormalities; including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
• −History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• −Class III or IV heart failure as defined by the New York Heart Association functional classification system (Appendix 2)
• −Uncontrolled hypertension
• −Patients requiring strong inhibitors or inducers of CYP3A4/5. See Appendix 10 for a list of these drugs
• −Any concurrent severe and/or uncontrolled medical condition or psychiatric disease that is likely to interfere with study procedures or results, or that in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → would constitute a hazard for participating in this study or that confounds the ability to interpret data from the study.
• −Patients that have had severe acute respiratory syndrome coronavirus 2 infection within 14 days for mild or asymptomatic infections or 28 days for severe/critical illness prior to initiating study treatment.
• −Active systemic infection that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.
• −Patients with a gastrointestinal disease that may significantly alter the absorption of iberdomide
• −Patients that have received a live vaccine within 3 months of initiating study treatment.
• −Pregnant or lactating females.
• −Patients that have undergone major surgery (as defined by the investigator) within 28 days of initiating study treatment.