Status:
COMPLETED
A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 25 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2019
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01456689
Start Date
April 25 2012
End Date
June 5 2019
Last Update
December 17 2020
Active Locations (8)
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1
Novartis Investigative Site
Chicago, Illinois, United States, 60637
2
Novartis Investigative Site
Ann Arbor, Michigan, United States, 48109
3
Novartis Investigative Site
Rochester, Minnesota, United States, 55905
4
Novartis Investigative Site
Houston, Texas, United States, 77030