Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

NCT06758375 | Recruiting Phase 2

• 1 other identifier: HE24-00015
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma, Newly Diagnosed

Keywords

Multiple myeloma; Teclistamab; Newly diagnosed multiple myeloma; Low-dose teclistamab

Outcome Measures

Primary Outcomes (1)

• To determine general response

  Evaluated according to the IMWG response criteria including MRD status.

  18 months after last teclistamab dose

Secondary Outcomes (2)

• To determine response duration

  Up to 18 months after last teclistamab dose

• Adverse events

  Through the study completion and up to 18 months after last teclistamab dose

Study Arms (1)

Arm 1

EXPERIMENTAL

Patients receiving 3 cycles of VRd followed by low-dose teclistamab.

Drug: Low-dose teclistamab

Interventions

Low-dose teclistamab DRUG

NDMM patients will receive VRd 3x cicles followed by low dose teclistamab.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. Jose E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (2)

• 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.

  PMID: 35749004 BACKGROUND

• 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.

  PMID: 34388396 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

David Gomez-Almaguer, MD

CONTACT

528186756718; dgomezalmaguer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Hematology Service

Model Details: One arm, open-label, phase 2 study

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 3, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): September 7, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

ME (1)