Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

Titre officiel

A Randomized, 2-Arm, Phase 3 Study of Elranatamab (PF-06863135) Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease-Positive After Undergoing Autologous Stem-Cell Transplantation

Sommaire:

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma who are MRD-positive after undergoing autologous stem cell transplant.

Participants in the study will either receive elrantamab as an injection under the skin at the study clinic or lenalidomide orally once daily at home. Participants who will receive elranatamab will start receiving one dose every week after the initial step-up doses. After 6 months of treatment, the frequency of clinic visits for injections will decrease to every other week. Participation in the study will be approximately five years.

Description de l'essai

Primary Outcome:

  • Minimal Residual Disease negativity rate
  • Progression Free Survival
Secondary Outcome:
  • Progression Free Survival
  • Overall minimal residual disease negativity rate
  • Duration of minimal residual disease negativity
  • Sustained minimal residual disease negativity rate
  • Complete response rate
  • Duration of complete response
  • Overall survival
  • Frequency of adverse events
  • Frequency of laboratory abnormalities
  • Pre-dose concentrations of elranatamab
  • Post-dose concentrations of elranatamab
  • Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
  • Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
  • Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Voir cet essai sur ClinicalTrials.gov

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