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

Novartis

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: LGH447; Drug: midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01456689

2011-003820-10 (EudraCT Number)

CLGH447X2101

Details and patient eligibility

About

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).

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

LGH447

Experimental group

Description:

Eligible patients will be treated with oral LGH447 until disease progression or occurrence of unacceptable toxicity.

Treatment:

Drug: LGH447

LGH447 and midazolam

Experimental group

Description:

Eligible patients will receive midazolam on two separate days, the first dose will be administered prior to the start of LGH447 and the second will be co-administered with LGH447. After that, the patients will continue to be treated with oral LGH447 until disease progression or occurrence of unacceptable toxicity.

Treatment:

Drug: midazolam

Drug: LGH447