Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Official Title

A Phase 3, Multicentre, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

Summary:

This is a multicentre, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM). The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.

Trial Description

Primary Outcome:

• Progression-free Survival (PFS)

• Overall Survival (OS)
• Event-free Survival (EFS)
• Overall Response Rate (ORR)
• Minimal Residual Disease (MRD)
• Complete Response (CR) Rate
• Duration of Response (DOR)
• Time to Response (TTR)
• Adverse Events (AEs)
• Pharmacokinetics- Cmax
• Pharmacokinetics- tmax
• Pharmacokinetics- AUC
• Pharmacokinetics- t-last
• Pharmacokinetics- AUC0-28days
• Subject-reported outcomes as measured by European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC-QLQ-C30)
• Subject-reported outcomes as measured by EuroQoL Group European Quality of Life-5 Dimensions health state classifier to 5 Levels (EQ-5D-5L) Health Questionnaire
• Subject-reported outcomes as measured by European Quality of Life Multiple Myeloma Module (EORTC-QLQ-MY20)
• Time to next antimyeloma treatment
• Progression-free survival after next line therapy (PFS2)

View this trial on ClinicalTrials.gov