Phase 3 Study of Teclistamab with Lenalidomide or Alone Versus Lenalidomide Alone for Maintenance Therapy in Newly Diagnosed Multiple Myeloma Patients After Stem Cell Transplant

Sponsor: Stichting European Myeloma Network

Sponsor score: 0

ClinicalTrials ID:NCT05243797

This clinical trial is testing whether the drug teclistamab, used alone or with lenalidomide, is more effective than lenalidomide alone as a maintenance treatment for patients with newly diagnosed multiple myeloma who have undergone a stem cell transplant.

Patient Parameters

Program Overview

The study aims to find out if using teclistamab, either by itself or with lenalidomide, can provide better maintenance therapy compared to using lenalidomide alone in patients who have recently been diagnosed with multiple myeloma and have had a stem cell transplant. This trial involves multiple centers and participants will be randomly assigned to different treatment groups.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with multiple myeloma and have received initial treatment.
  • Have only had one type of treatment and shown at least a partial improvement without the disease getting worse.
  • Can tolerate the starting dose of lenalidomide.
  • Have not received any maintenance therapy before.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Have lab test results within a specific range.

Exclusion Criteria

  • Have received any previous treatment targeting BCMA.
  • Have had any therapy involving redirected immune cells or gene-modified cell therapy, like CAR-T cells.
  • Stopped lenalidomide treatment due to side effects.
  • Experienced disease progression before the study.
  • Have taken a high dose of corticosteroids recently.
  • Have received a live vaccine within four weeks before starting the study treatment. Non-live vaccines, like those for COVID-19, are allowed.

Locations

FACILITYZIPCITYSTATE
The University of Arizona Cancer Center85004PhoenixArizona
University of California-Davis Cancer Center95817SacramentoCalifornia
University of Colorado Hospital80045AuroraColorado
Colorado Blood Cancer Institute80218DenverColorado
Yale New Haven Hospital06519New HavenConnecticut
Blood & Marrow Transplant Center, Florida Hospital Medical Group32804OrlandoFlorida
Moffitt at Memorial Healthcare System33612TampaFlorida
University of Illinois Medical Center at Chicago60612ChicagoIllinois
IU Health Blood and Bone Marrow Stem Cell Transplant and Immune Cell Therapy Program46202IndianapolisIndiana
Greenebaum Cancer Center UM of MD21201BaltimoreMaryland

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