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

Inclusion criteria

• Must be able to provide written informed consent before any screening procedures.
• Male or female patients ≥18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
• Patients with a confirmed diagnosis of multiple myeloma who have received two or more lines of therapy including an IMiD and PI, and are relapsed and/or refractory to their most recent line of therapy. Patients who have received a prior autologous bone marrow transplant and otherwise meet the inclusion criteria are eligible for this study.
• Must have measurable disease defined by at least 1 of the following 3 measurements:
• Serum M-protein ≥ 0.5 g/dL OR
• Urine M-protein ≥ 200 mg/24 hours OR
• Serum free light chain (FLC) > 100 mg/L of involved FLC
• All patients must be willing to undergo a mandatory serial bone marrow aspirate and/or biopsy at screening and subsequently following treatment for the assessment of biomarker/pharmacodynamics and disease status. Exceptions may be considered after documented discussion with Novartis.

Other inclusion criteria included in the protocol might apply.

Exclusion criteria

• Use of systemic chronic steroid therapy (≥10mg /day of prednisone or equivalent), or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal, or ophthalmic steroids are allowed.
• Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.
• Active, known or suspected autoimmune disease other than patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur.
• Patients with prior known toxicity attributed to PD-1 or PDL-1 directed therapy, which led to discontinuation of these agents, will be excluded from the PDR001 containing arms of the study.
• Patients with prior known toxicity from IL-17A directed therapy, which led to discontinuation of the study treatment, will be excluded from CJM112 containing arms of the study.
• Any of the following clinical laboratory results during screening (i.e., within 28 days before the first dose of study treatment):

• Absolute neutrophil count (ANC) < 1,000/mm3 without growth factor support within 7 days prior to testing
• Platelet count < 75,000 mm3 without transfusion support within 7 days prior to testing
• Bilirubin > 1.5 times the upper limit of the normal range (ULN)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN
• Calculated creatinine clearance < 30 ml/min according to Cockcroft-Gault equation Other exclusion criteria included in the protocol might apply.