A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2019-06-05
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this dose escalation study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of LGH447 as a single agent when administered orally once daily to adult patients with Multiple Myeloma (MM).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• Confirmed diagnosis of multiple myeloma that is relapsed and/or refractory for which no curative option exists.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

• During the dose expansion part of the study patients must have measurable disease defined by at least 1 of the following 2 measurements:

• Serum M-protein ≥ 0.5 g/dL

• Urine M-protein ≥ 200 mg/24 hours

• Serum free light chain (FLC) > 100 mg/L of involved FLC

Exclusion Criteria:

• Patients who are currently receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with LGH447:

• Strong inhibitors or inducers of CYP3A4

• CYP3A4 substrates with narrow therapeutic index

Other protocol-defined inclusion/exclusion criteria may apply.