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Dose escalation of CJM112 in combination with a fixed dose of PDR001

Dose escalation of LCL161 in combination with a fixed dose of PDR001

PDR001

CJM112

LCL161

Novartis Pharmaceuticals

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.

The study is comprised of 3 treatment arms:

* Single agent CJM112 (Arm A)
* A fixed dose of PDR001 in combination with CJM112 (Arm B)
* A fixed dose of PDR001 in combination with LCL161 (Arm C)

Patients may switch from treatment on Arm A to the corresponding CJM112 dose level on Arm B at the time of disease progression if that dose level has been declared safe, and if patients do not have any DLTs on single agent CJM112. Otherwise, patients will switch to a lower dose level that has been declared safe. No other cross-over between treatment arms is allowed.

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

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

number of patients reporting dose limiting toxicity

Number of patients with treatment-related adverse events as assessed by CTCAE v4.0

Frequency of patients requiring a dose interruption

Frequency of patients discontinuing treatment.

Frequency of patients requiring a dose reduction.

Presence and/or concentration of anti-PDR001, and anti-CJM112 antibodies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Multiple Myeloma	NCT03111992	Multiple Myelom...	PDR001 CJM112 LCL161	18 Years -	Novartis
Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Multiple Myeloma	NCT03111992	Multiple Myelom...	PDR001 CJM112 LCL161	18 Years -	Novartis

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