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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

24 weeks

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589B2206

NCT ID:

NCT00532675

Start Date:

April 2008

Completion Date:

October 2013

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Multiple Myeloma
  • Lenalidomide
  • Revlimid
  • Dexamethasone
  • LBH589
  • Combination
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

St. Vincent's Comprehensive Cancer Center New York, New York  10011
University of California San Francisco UCSF MC at Parnassus (SC) San Francisco, California  94101
Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst. Atlanta, Georgia  30322