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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Mayo Clinic Arizona
Phoenix, Arizona, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Novartis Investigative Site
Freiburg im Breisgau, Germany
Novartis Investigative Site
Heidelberg, Germany
Number of patients reporting dose limiting toxicities
number of patients reporting dose limiting toxicity
Time frame: 2 months
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
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 24 months
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
Frequency of patients requiring a dose interruption
Time frame: 24 months
The number of patients treated with single agent CJM112, or PDR001 in combination with either CJM112 or LCL161, who discontinued treatment
Frequency of patients discontinuing treatment.
Time frame: 24 months
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
Frequency of patients requiring a dose reduction.
Time frame: 24 months
Immunogenicity of PDR001 and CJM112
Presence and/or concentration of anti-PDR001, and anti-CJM112 antibodies
Time frame: First 6 months of study treatment
Overall Response Rate (ORR)
Determine ORR in each arm of the study
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Novartis Investigative Site
Kiel, Germany
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Salamanca, Castille and León, Spain
Novartis Investigative Site
Madrid, Spain
Time frame: 24 Months
Best Overall Response (BOR)
Determine BOR in each arm of the study
Time frame: 24 Months
Progression Free Survival (PFS)
Determine PFS in each arm of the study
Time frame: 24 Months
Disease Control Rate (DCR)
Determine DCR in each arm of the study
Time frame: 24 Months
AUC of PDR001, CJM112 and LCL161
AUC
Time frame: 24 months
Cmax of PDR001, CJM112 and LCL161
Cmax
Time frame: 24 months
Tmax of PDR001, CJM112 and LCL161
Tmax
Time frame: 24 months
Half-life of PDR001, CJM112 and LCL161
Half-life
Time frame: 24 months
Concentration vs time profile of PDR001, CJM112 and LCL161
Concentration vs time
Time frame: 24 months