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

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT01456689

Run by

Novartis Pharmaceuticals

People needed

79

Starts

2012-04-25

Expected to finish

2019-06-05

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Rochester, Minnesota, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Kiel, Germany
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Salamanca, Castille and León, Spain

Full record on ClinicalTrials.gov

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