Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario Dr. Jose E. Gonzalez

About this trial

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.

Eligibility criteria

Qualifiers

≥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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Low-dose teclistamab

Treatment groups

10 Participants
are divided into 1 treatment group