An expanded treatment protocol of panobinostat in combination therapy for relapsed and relapsed and refractory (RR) cancer of plasma cells.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

- Patient with diagnosis of multiple myeloma, based on IMWG definitions, that is relapsed or relapsed and refractory to at least two prior regimens including bortezomib and an immunomodulatory agent.
a. Relapsed, defined by disease that recurred in a patient that responded under at least two prior regimens including bortezomib and an immunomodulatory agent, by reaching a MR or better, and had not progressed under current therapy or up to 60 days of last dose of this therapy. Patients previously treated with bortezomib are eligible.
b. Relapsed-and-refractory to a therapy, provided that patient meets both conditions:
•patient has relapsed to at least two prior regimens including bortezomib and an immunomodulatory agent
•and patient was refractory to at least two prior regimens including bortezomib and an immunomodulatory agent by either not reaching a MR, or progressed while under this therapy, or within 60 days of its last dose. Patients previously treated with bortezomib are eligible even if they are deemed refractory.

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of = 2
- Absolute neutrophil count (ANC) = 1.0 x 109 /L
- Platelet count = 100 x 109 /L

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

- Patient has shown intolerance or has any contraindications to bortezomib, dexamethasone or panobinostat
- Patient is refractory to panobinostat
- Patient has grade = 2 peripheral neuropathy
- Patient taking any anti-cancer therapy concomitantly (bisphosphonates are permitted)
- Patient requires medication with a risk of prolonging the QT interval or inducing Torsades de pointes

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To provide multiple myeloma patients early access to treatment with panobinostat and to further evaluate safety of panobinostat when used in combination with BTZ/Dex in patients with multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent. ;Secondary Objective: Secondary:<br>- To assess the efficacy of panobinostat when used in combination with BTZ/DEX by overall response rate (CR, nCR or PR) and progression-free survival per EBMT criteria ;Primary end point(s): AEs, Grade 3&4 AEs & SAEs, events of special interest, AEs leading to discontinuation, and deaths.;Timepoint(s) of evaluation of this end point: discontinuation or deaths or after 16 cycles

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary:<br>- Overall response rate per modified EBMT criteria by investigator assessment<br>- Progression-free survival (PFS) based on investigator-assessed progression per modified EBMT criteria<br><br>;Timepoint(s) of evaluation of this end point: discontinuation or deaths or after 16 cycles

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