Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06758375

Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

Led by Hospital Universitario Dr. Jose E. Gonzalez · Updated on 2025-03-20

10

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Newly diagnosed with multiple myeloma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception
  • Male participants must agree to use effective contraception such as condoms or vasectomy
Not Eligible

You will not qualify if you...

  • Previous treatment for multiple myeloma
  • Active central nervous system involvement or signs of meningeal involvement
  • Diagnosis of plasma cell leukemia, Waldenstr�f6m's macroglobulinemia, POEMS syndrome, or AL amyloidosis
  • Severe active infections caused by viruses, bacteria, or fungi
  • Lung disease requiring supplemental oxygen
  • History of bone marrow transplantation (allogeneic or autologous)
  • Vaccination with live attenuated virus within 4 weeks before teclistamab
  • Major surgery within 2 weeks before first teclistamab dose or incomplete recovery from surgery
  • Presence of other active cancers
  • Infection with hepatitis B, hepatitis C, or HIV
  • Stroke or seizures within the last 6 months
  • Severe heart failure (NYHA class III-IV)
  • Heart attack or coronary surgery within the last 6 months
  • Pregnant women before first treatment dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario Dr. Jose E. Gonzalez

Monterrey, Nuevo León, Mexico, 64460

Actively Recruiting

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Research Team

D

David Gomez-Almaguer, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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