A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma

Official Title

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Summary:

The purpose of this study is evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

Trial Description

Primary Outcome:

• Overall Response Rate (ORR)

Secondary Outcome:

• Duration of Response (DOR)
• Very Good Partial Response (VGPR) or Better Rate
• Complete Response (CR) or Better Rate
• Stringent Complete Response (sCR) Rate
• Time to Response (TTR)
• Progression-free Survival (PFS)
• Overall Survival (OS)
• Minimal Residual Disease (MRD) Negative Rate
• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
• Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
• Number of Participants with AEs by Severity
• Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values
• Serum Concentration of Teclistamab
• Number of Participants with Teclistamab Antibodies
• Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
• Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
• Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
• Overall Response Rate (ORR) in Participants with High-risk Molecular Features

Study record NCT03145181 is Phase 1 part of this study and study record NCT04557098 is Phase 2 part of this study.

View this trial on ClinicalTrials.gov