Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma

Novartis

Status and phase: Completed; Phase 2

Conditions: Relapse/Refractory Multiple Myeloma

Treatments: Drug: bortezomib; Drug: dexamethasone; Drug: LBH589 (panobinostat)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02290431

CLBH589D1201

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient had a previous diagnosis of multiple myeloma
• Patient required retreatment for multiple myeloma
• Patient had measurable M component in serum or urine at study screening

Exclusion criteria

• Primary refractory disease (patients that never reached at least an minor response for over 60 days under any prior therapy)
• Patient who had been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose
• Patient received prior treatment with DAC inhibitors including panobinostat
• Patient had impaired cardiac function, or a prolonged QTc interval at screening ECG

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

LBH589 + bortezomib + dexamethasone

Experimental group

Description:

Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.

Treatment:

Drug: bortezomib

Drug: dexamethasone

Drug: LBH589 (panobinostat)