MedTrace Logo

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

NCT05243797 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1594

Last updated 2026-03-25

No results posted yet for this study

Summary

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Conditions

Interventions

DRUG

Teclistamab

Teclistamab will be administered via a subcutaneous injection (SC)

DRUG

Lenalidomide

Lenalidomide will be administered orally

Sponsors & Collaborators

  • Janssen Pharmaceutica

    collaborator INDUSTRY

  • European Myeloma Network B.V.

    lead NETWORK

Principal Investigators

  • Niels van de Donk, Professor · Amsterdam UMC, Vrije Universiteit Amsterdam

  • Elena Zamagni, Professor · IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2028-04-30
Completion
2032-04-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Serbia
  • South Korea
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05243797 on ClinicalTrials.gov