Phase
Condition
Multiple Myeloma
Bone Neoplasm
Cancer/tumors
Treatment
Low-dose teclistamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥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 tostarting treatment and agree to use a highly effective method of contraception, suchas a hormonal method that inhibits ovulation, an intrauterine device, or a vasectomypartner.
Males: agree to use a highly effective contraceptive method, such as a male condomor vasectomy.
Exclusion
Exclusion Criteria:
History of previous treatment for MM.
Active central nervous system (CNS) involvement or clinical signs of meningealinvolvement of multiple myeloma.
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.
Vaccination with live attenuated virus in the 4 weeks prior to teclistamabadministration.
Major surgery during the 2 weeks prior to the first dose or absence of completerecovery from surgery.
Presence of other concomitant malignancy.
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 AssociationStage).
Acute myocardial infarction or history of coronary revascularization surgery in thelast 6 months.
Women of childbearing age: active pregnancy prior to the first administration oftreatment.
Study Design
Study Description
Connect with a study center
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León 64460
MexicoActive - Recruiting
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