A Multi-Center, Open-Label, Dose Escalation, Phase 1 Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
Trial status: Open for Enrollment
Why is this study being done?
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).
Who is eligible to participate?
- 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
- 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.