Free regimen of Dexamethasone as initial therapy for advanced relapsed/refractory multiple myeloma: an open-label randomized, non-inferiority, controlled trial

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• • Contraindications to investigational medicinal products or auxiliary medicinal product • Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies or if the patient received an anti-CD38 within the last 6 months. • Previous treatment according to the ICARIA schema with pomalidomide orIKEMA schema with carfilzomib • Allogenic hematopoietic cell transplant (HCT, regardless of timing). • Planned to undergo an HCT prior to progression of disease ie, these patients should not be enrolled in order to reduce disease burden prior to transplant. • History of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator is considered cured with minimal risk of recurrence within 3 years). • Known MM meningeal Involvement. • Plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström’s macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis. • Any concurrent medical condition or disease (e.g., active systemic infection) that is likely to interfere with study procedures or results, or that, in the opinion, of the Investigator would constitute a hazard by participating in this study. • Uncontrolled chronic obstructive pulmonary disease (COPD) • Clinically significant cardiac disease. • Seropositive for hepatitis B with positive PCR • Seropositive for human immunodeficiency virus (HIV) or hepatitis C. • Creatinine clearance ≤30 mL/min • Pregnancy or absence of effective contraceptive method for women of childbearing potential • Lactation • Participation to another interventional clinical trial except with the agreement of the coordinating investigator.• Inability to give written informed consent