Clinical trial · Interventional
Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.
A Phase Ib, Multi-center, Open-label, Dose-escalation Study of Oral LBH589 When Administered in Combination With Oral Lenalidomide & Dexamethasone in Adult Patients With Multiple Myeloma
NCT00532675CI-TRIAL-00049009completedPhase 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)
This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma
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 |
|---|---|---|---|
| LBH589 | Drug | Panobinostat | ALIAS |
| Lenalidomide | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- PAN 5 mg
- description
- Panobinostat 5 mg
- interventionNames
- Drug: LBH589
- Combination Product: Lenalidomide
- type
- EXPERIMENTAL
- label
- PAN 10 mg
- description
- Panobinostat 10 mg
- interventionNames
- Drug: LBH589
- Combination Product: Lenalidomide
- type
- EXPERIMENTAL
- label
- PAN 20 mg
- description
- Panobinostat 20 mg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Patients must have a diagnosis of active multiple myeloma * Patients must have received at least one prior line of therapy and their disease has relapsed.. * Patients must be suitable for treatment with lenalidomide \& dexamethasone. * Adults ≥ 18 years old * ECOG Performance Status ≤ 2 * Life expectancy \> 12 weeks * Patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function. * Able to sign informed consent and to comply with the protocol Exclusion criteria: * Primary refractory MM * Peripheral neuropathy ≥ CTCAE grade 2 * Impaired cardiac function or clinically significant cardiac diseases * Impairment of GI function or GI disease that may significantly alter the absorption of LBH589 * Patients with diarrhea \> CTCAE grade 1 * Patients using medications that have a relative risk of prolonging the QT interval * Concomitant use of CYP3A4 inhibitors * Patients with a history of deep vein thrombosis or thromboembolism within \< 6 months prior to starting study treatment * Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy * Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using 2 reliable forms of birth control * Male patients whose sexual partners are WOCBP and who are unable to use a latex condom during sexual contact (even if they have undergone a vasectomy) * Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff. Other protocol defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.