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OpenTrials
Completed

NCT Number: NCT00532675

Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.

This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, South Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LBH589

Drug

PAN 5 mg and PAN 20 mg capsules

Other names: Panobinostat, PAN

Lenalidomide

Combination Product

Lenalidomide 5mg or 25 mg

Primary outcomes

  1. To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone

    Time frame: 24 weeks

Secondary outcomes

  1. Safety and tolerability assessed by monitoring of adverse events, serious adverse events and laboratory parameters To characterize the pharmacokinetic profile of the study treatment To characterize the pharmacodynamic profile of the study treatment

    Time frame: Da1 to Day 3 (week 1 of first cycle)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2007
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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