Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients
10 patients around the world
Available in Mexico
This single-arm, open-label study aims to determine the efficacy and safety of low-dose
(1.0 mg/kg), limited-duration teclistamab as a consolidation scheme in newly diagnosed
multiple myeloma (NDMM) patients after 3 (three) VRd cycles as induction therapy.
Patients with MMND who meet the established inclusion criteria will be invited to
participate. A single-arm phase 2 study will be conducted in the Hematology Department of
the University Hospital, where an induction schedule of 3 cycles of bortezomib,
lenalidomide, and dexamethasone (VRd) will be administered followed by consolidation with
4 therapeutic doses of teclistamab at 1.0 mg/kg subcutaneously. Four weeks after the last
dose of teclistamab, the clinical response will be assessed according to standard
International Myeloma Working Group (IMWG) criteria. Those with a complete response (CR)
or better will be assessed for measurable residual disease (MRD) with multiparametric
flow cytometry with a sensitivity of 10^6. Patients with CR and negative MRD will be kept
under active surveillance for 18 months, while those with positive MRD or high
cytogenetic risk will be offered biweekly bortezomib as maintenance. On the other hand,
patients with very good partial response (VGPR) or worse will be offered 1-2 additional
therapeutic doses of teclistamab and reevaluated 4 weeks after the last dose. Finally,
patients who do not achieve CR will exit the study and will continue their management
according to the standard of care recommended by their treating physician.
Hospital Universitario Dr. Jose E. Gonzalez
1Research sites
10Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
≥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.
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.
Sites
Hospital Universitario Dr. José Eleuterio González
Recruiting
Av. Dr. José Eleuterio González, Mitras Centro, 64460 Monterrey, N.L., Mexico
SponsorHospital Universitario Dr. Jose E. Gonzalez