Conditions: Relapsed and Bortezomib Refractory Multiple Myeloma Refractory Multiple Myeloma Multiple Myeloma in Relapse
Keywords: Multiple Myeloma Relapsed Multiple Myeloma Refractory Multiple Myeloma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 55
Healthy volunteers: no

Brief summary:
This study is designed to assess the effectiveness of the combination of Panobinostat plus Bortezomib and Dexamethasone in patients with relapsed and bortezomib refractory Multiple Myeloma.

Detailed description:
This is a phase II, two stage, single arm, open label, multi-center study of oral PAN in combination with BTZ/Dex in patients with relapsed and refractory multiple myeloma, who are bortezomib-refractory and have received at least 2 prior lines of therapy. Patients must have been exposed to an iMID (lenalidomide or thalidomide) and progressed on or within 60 days of their last BTZ-containing line of therapy.

Arms:
arm 1: panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma

Interventions: intervention 1: panobinostat intervention 2: bortezomib intervention 3: dexamethasone
Intervention descriptions: intervention 1: PAN 20 mg PO given TIW, weeks 1\&2 of each 3-week cycle;• BTZ 1.3 mg/m2 IV push given BIW weeks 1\&2 of each 3 week cycle (days 1,4,8 and 11);• Dex 20 mg PO given QIW, weeks 1\&2 of each 3-week cycle (days 1,2,4,5,8,9,11 and 12) intervention 2: None intervention 3: None

Protocol document: