A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/3/2019 |
| Start Date: | April 25, 2012 |
| End Date: | December 31, 2019 |
A Multi-Center, Open-Label, Dose Escalation, Phase 1 Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
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).
(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).
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.
We found this trial at
5
sites
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