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.

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma, Newly Diagnosed
• Intervention / Treatment: Drug: Low-dose teclistamab

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: David Gomez-Almaguer, MD; Phone Number: 528186756718; Email: dgomezalmaguer@gmail.com

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Recruiting
      • Hospital Universitario Dr. Jose E. Gonzalez
      • Contact: David Gomez-Almaguer, MD; Phone Number: 528186756718; Email: dgomezalmaguer@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Patients receiving 3 cycles of VRd followed by low-dose teclistamab.	Drug: Low-dose teclistamab; NDMM patients will receive VRd 3x cicles followed by low dose teclistamab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine general response	Evaluated according to the IMWG response criteria including MRD status.	18 months after last teclistamab dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine response duration	Evaluated according to the IMWG response criteria including MRD status.	Up to 18 months after last teclistamab dose
Adverse events	To report the side effects related to the trial's treatment as per the international guidelines for chemo- and immunotherapy.	Through the study completion and up to 18 months after last teclistamab dose

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Publications and helpful links

General Publications

• Girgis S, Lin SXW, Pillarisetti K, Banerjee A, Stephenson T, Ma X, Shetty S, Yang TY, Hilder BW, Jiao Q, Hanna B, Adams HC 3rd, Sun YN, Sharma A, Smit J, Infante JR, Goldberg JD, Elsayed Y. Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma. Target Oncol. 2022 Jul;17(4):433-439. doi: 10.1007/s11523-022-00893-y. Epub 2022 Jun 24. Erratum In: Target Oncol. 2022 Sep;17(5):609. doi: 10.1007/s11523-022-00904-y.
• Usmani SZ, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Rosinol L, Chari A, Bhutani M, Karlin L, Benboubker L, Pei L, Verona R, Girgis S, Stephenson T, Elsayed Y, Infante J, Goldberg JD, Banerjee A, Mateos MV, Krishnan A. Teclistamab, a B-cell maturation antigen x CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Epub 2021 Aug 10.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): September 7, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Multiple myeloma; Teclistamab; Newly diagnosed multiple myeloma; Low-dose teclistamab
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: HE24-00015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No