A Study to Compare Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) in Participants With Newly Diagnosed Multiple Myeloma

Titre officiel

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

Sommaire:

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

Description de l'essai

Primary Outcome:

• Progression Free Survival (PFS)
• Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)

Secondary Outcome:

• Very Good Partial Response (VGPR) or Better
• Complete Response (CR) or Better
• MRD-negative CR
• Progression Free Survival on Next-line Therapy (PFS2)
• Overall Survival (OS)
• Number of Participants with Adverse Events (AEs) by Severity
• Number of Participants with Abnormalities in Laboratory Parameters
• Number of Participants with Abnormalities in Vital Signs
• Number of Participants with Abnormalities in Physical Examination
• Number of Participants with Abnormalities in Electrocardiogram (ECG)
• Serum Concentrations of Teclistamab
• Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab
• Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
• Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
• Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
• Time to Sustained Worsening in Symptoms, Functioning, and HRQoL

Teclistamab is a full-size, immunoglobin G4 proline, alanine, alanine (IgG4-PAA) bispecific antibody that targets the cluster of differentiation 3 (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. DRd is an approved regimen for the treatment of participants with newly diagnosed, transplant-ineligible multiple myeloma. The primary hypothesis of this study is that Tec-DR will significantly improve the rate of progression free survival (PFS) or sustained minimal residual disease (MRD)-negative complete response (CR) compared with DRd in participants with newly diagnosed multiple myeloma who are ineligible or not intended for autologous stem cell transplant (ASCT) as initial therapy. The study will be conducted in 3 phases: Screening, Treatment, and Follow-up. Safety Assessment includes adverse events (AEs), laboratory test results, vital sign measurements, physical examination findings, assessment of Eastern Cooperative Oncology Group (ECOG) performance status grade, and effector cell associated encephalopathy (ICE) score (Tec-DR only). Total duration of this study will be up to 9 years.

Voir cet essai sur ClinicalTrials.gov