Clinical trial · Interventional
A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
A Multi-Center, Open-Label, Dose Escalation, Phase 1 Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
NCT01456689CI-TRIAL-00048915completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LGH447 | Drug | — | UNRESOLVED |
| midazolam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LGH447
- description
- Eligible patients will be treated with oral LGH447 until disease progression or occurrence of unacceptable toxicity.
- interventionNames
- Drug: LGH447
- type
- EXPERIMENTAL
- label
- LGH447 and midazolam
- description
- 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.
- interventionNames
- Drug: LGH447
- Drug: midazolam
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.