This single-arm, open-label study aims to determine the efficacy and safety of low-dose, limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients.
≥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.
History of previous treatment for MM.
Active central nervous system (CNS) involvement or clinical signs of meningeal involvement 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.
Single group
Low-dose teclistamab
DrugNDMM patients will receive VRd 3x cicles followed by low dose teclistamab.
To determine general response
Evaluated according to the IMWG response criteria including MRD status.
To determine response duration
Evaluated according to the IMWG response criteria including MRD status.
Adverse events
To report the side effects related to the trial's treatment as per the international guidelines for chemo- and immunotherapy.
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