๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* โฅ18 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 Criteria:
* History of previous treatment for MM.
* Active central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
* Plasma cell leukemia, Waldenstrรถm'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.
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Mexico
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.