RecruitingPhase 2NCT06758375
Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients
Low-dose Teclistamab As Consolidation in the First-line Treatment of Patients with Newly Diagnosed Multiple Myeloma.
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Enrollment
10 participants
Start Date
Mar 3, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 18 Years
Inclusion Criteria5
- ≥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 Criteria14
- 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.
- Pulmonary disease requiring supplemental oxygen.
- History of allogeneic or autologous hematopoietic cell transplantation.
- 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.
- 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.
- Women of childbearing age: active pregnancy prior to the first administration of treatment.
Interventions
DRUGLow-dose teclistamab
NDMM patients will receive VRd 3x cicles followed by low dose teclistamab.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06758375
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