Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

Ki vehet részt

• ≥18 years of age
• Newly diagnosed multiple myeloma
• Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1
• Women of childbearing potential must have a negative serum pregnancy test prior to starting treatment and agree to use a highly effective method of contraception, such as a hormonal method that inhibits ovulation, an intrauterine device, or a vasectomy partner
• Males: agree to use a highly effective contraceptive method, such as a male condom or vasectomy

Ki nem vehet részt

• History of previous treatment for MM
• Vaccination with live attenuated virus in the 4 weeks prior to teclistamab administration
• Major surgery during the 2 weeks prior to the first dose or absence of complete recovery from surgery
• Presence of other concomitant malignancy
• Women of childbearing age: active pregnancy prior to the first administration of treatment
• Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or AL amyloidosis
• Severe active infection secondary to viruses, bacteria or fungi
• Pulmonary disease requiring supplemental oxygen
• History of allogeneic or autologous hematopoietic cell transplantation
• Hepatitis B and C virus infection or human immunodeficiency virus (HIV) infection
• Cerebrovascular events or seizures in the last 6 months
• Congestive heart failure class III-IV according to NYHA (New York Heart Association Stage)
• Acute myocardial infarction or history of coronary revascularization surgery in the last 6 months
• Active central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma