Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

Last updated: March 19, 2025
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple Myeloma

Bone Neoplasm

Cancer/tumors

Treatment

Low-dose teclistamab

Clinical Study ID

NCT06758375
HE24-00015
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • ≥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 tostarting treatment and agree to use a highly effective method of contraception, suchas a hormonal method that inhibits ovulation, an intrauterine device, or a vasectomypartner.

  • Males: agree to use a highly effective contraceptive method, such as a male condomor vasectomy.

Exclusion

Exclusion Criteria:

  • History of previous treatment for MM.

  • Active central nervous system (CNS) involvement or clinical signs of meningealinvolvement 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 teclistamabadministration.

  • Major surgery during the 2 weeks prior to the first dose or absence of completerecovery 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 AssociationStage).

  • Acute myocardial infarction or history of coronary revascularization surgery in thelast 6 months.

  • Women of childbearing age: active pregnancy prior to the first administration oftreatment.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Low-dose teclistamab
Phase: 2
Study Start date:
March 03, 2025
Estimated Completion Date:
December 01, 2026

Study Description

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.

Connect with a study center

  • Hospital Universitario Dr. Jose E. Gonzalez

    Monterrey, Nuevo León 64460
    Mexico

    Active - Recruiting

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