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A Multi-Center, Open-Label, Dose Escalation, Phase 1 Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

A Multi-Center, Open-Label, Dose Escalation, Phase 1 Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma


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

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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate the MTD and/or RDE

Outcome Description:

Incidence rate of dose limiting toxicity

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLGH447X2101

NCT ID:

NCT01456689

Start Date:

April 2012

Completion Date:

July 2014

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Multiple Myeloma
  • MM
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Michigan Comprehensive Cancer Center Main OfficeAnn Arbor, Michigan  48109-0944
Mayo Clinic - Rochester Mayo 3Rochester, Minnesota  55905
MD Anderson Cancer Center/University of Texas Dept.ofMDAndersonCancerCtr(SC)Houston, Texas  77030-4009
University Chicago Hospital Dept of OncologyChicago, Illinois  60637