Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Multiple Myeloma

Official Title

Phase I/Ib, Multi-centre, Open-label, Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Relapsed and/or Refractory Multiple Myeloma

Summary:

The purpose of this study is to assess the safety, tolerability, and identify the recommended doses of single agent CJM112, and of CJM112 or LCL161 in combination with PDR001, in patients with relapsed and/or refractory multiple myeloma.

Trial Description

Primary Outcome:

• Number of patients reporting dose limiting toxicities
• The number of patients who experience a treatment-related adverse event after being treated with a single dose of single agent CJM112, or two doses of PDR001 in combination with CJM112 or LCL161
• The number of patients requiring interruptions after a single dose of single agent CJM112, or two doses of PDR001 in combination with CJM112 or LCL161
• The number of patients treated with single agent CJM112, or PDR001 in combination with either CJM112 or LCL161, who discontinued treatment
• The number of patients requiring a dose reduction after a single dose of single agent CJM112, or two doses of PDR001 in combination with CJM112 or LCL161

• Immunogenicity of PDR001 and CJM112
• Overall Response Rate (ORR)
• Best Overall Response (BOR)
• Progression Free Survival (PFS)
• Disease Control Rate (DCR)
• AUC of PDR001, CJM112 and LCL161
• Cmax of PDR001, CJM112 and LCL161
• Tmax of PDR001, CJM112 and LCL161
• Half-life of PDR001, CJM112 and LCL161
• Concentration vs time profile of PDR001, CJM112 and LCL161

View this trial on ClinicalTrials.gov