A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Multiple Myeloma, MM
Eligibility 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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
LGH447
LGH447 and midazolam
Eligible patients will be treated with oral LGH447 until disease progression or occurrence of unacceptable toxicity.
Eligible patients will receive midazolam on two separate days, the first dose will be administered prior to the start of LGH447 and the second will be co-administered with LGH447. After that, the patients will continue to be treated with oral LGH447 until disease progression or occurrence of unacceptable toxicity.