Low-Dose Teclistamab Tested in Newly Diagnosed Multiple Myeloma
Tests low-dose teclistamab as follow-up treatment in adults with newly diagnosed multiple myeloma.
Plain-language title generated from the registry record
Registry title: Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients
Key facts
- Where
- Monterrey, MexicoSee the site
- Phase
- Phase 2
Where in Mexico
- Hospital Universitario Dr. Jose E. GonzalezMonterrey, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitario Dr. Jose E. Gonzalez
- Trial code
- NCT06758375
- Record updated
- 20 March 2025
- Original description
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.Read full original descriptionShow less
Low-dose Teclistamab As Consolidation in the First-line Treatment of Patients with Newly Diagnosed Multiple Myeloma.
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.
Inclusion: ≥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.
Exclusion: 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.