A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

Titre officiel

A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

Sommaire:

The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-cluster of differentiation 38 (CD38) treatment naive participants with newly diagnosed multiple myeloma who are MRD positive as determined by next generation sequencing (NGS) at screening, following high-dose therapy (HDT) and autologous stem cell transplant (ASCT).

Description de l'essai

Primary Outcome:

• Percentage of Participants with Minimal Residual Disease (MRD) Negative Status as determined by NGS

• Progression-free Survival (PFS)
• Percentage of Participants with Overall Minimal Residual Disease (MRD) Negative Status
• Durable MRD Negative Rate
• Percentage of Participants Achieving Complete Response (CR) or Stringent Complete Response (sCR)
• Overall Survival (OS)
• Duration of Complete Response (CR)
• Change in Health-Related Quality of Life (HRQoL) as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30
• Change in HRQoL as Measured by European Quality of Life Five Dimensions Questionnaire-5-level (EQ-5D-5L)
• Change in HRQoL as Measured by EORTC QLQ-Multiple Myeloma Module (MY20)
• Number of Participants with Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability

Voir cet essai sur ClinicalTrials.gov