A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Myeloma, Multiple Myeloma, MM
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: LGH447 Type: Drug
Name: midazolam Type: Drug
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
University Chicago Hospital Dept of Oncology
Chicago, Illinois, United States
Status: Recruiting
Contact: Morgan Pittman - 773-702-1835 - mpittman@bsd.uchicago.edu
University of Michigan Comprehensive Cancer Center Main Office
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Shelagh Elliott - 734-936-5310 - shelagh@umich.edu
Mayo Clinic - Rochester Mayo 3
Rochester, Minnesota, United States
Status: Recruiting
Contact: Susan Wescott - Wescott.susan@mayo.edu
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(SC)
Houston, Texas, United States
Status: Recruiting
Contact: Victoria M Gray - 713-563-8772 - VMGray@mdanderson.org
Novartis Investigative Site
Heidelberg, Germany
Status: Recruiting
Novartis Investigative Site
Kiel, Germany
Status: Recruiting
Novartis Investigative Site
Singapore, Singapore
Status: Recruiting
Novartis Investigative Site
Salamanca, Castilla y Leon, Spain
Status: Recruiting
Start Date
April 2012
Completion Date
November 2016
Sponsors
Novartis Pharmaceuticals
Source
Novartis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page