This study will evaluate efficacy and tolerability of iberdomide, bortezomib, dexamethasone and isatuximab on demand administered in combination for newly diagnosed transplant-ineligible multiple myeloma patients.
Must understand and voluntarily sign informed consent form
Age ≥ 65 years at the time of signing consent
Must be able to adhere to the study visit schedule and other protocol requirements.
Previously untreated, transplant ineligible, symptomatic multiple myeloma as defined by the criteria below.
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.
Pregnant or lactating females.
Renal failure requiring hemodialysis or peritoneal dialysis.
Single group
Iberdomide
DrugAvailable as formulated capsules and administered as oral medication
Bortezomib
DrugAdministered as subcutaneous injection
Dexamethasone
DrugAdministered as oral medication
Isatuximab
DrugAdministered as subcutaneous injection
Evaluate Rate of Stringent Complete Response (sCR) transplant ineligible multiple myeloma patients.
Evaluate the rate of stringent complete response (sCR) after 4 cycles of therapy of Iber+ weekly Bd in newly diagnosed transplant ineligible multiple myeloma patients.
Evaluate Objective Response
Evaluate objective response as per IMWG criteria: progressive disease, stable disease, partial response, very good partial response, complete response and stringent complete response according to IMWG criteria. Multiple measurements will be aggregated to arrive at one reported value (e.g., weight and height will be combined to report BMI in kg/m\^2).
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