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

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Multiple myeloma; MedDRA version: 17.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864

• Registration Number: EUCTR2014-003239-21-NO
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

- Patient with diagnosis of multiple myeloma, based on IMWG definitions
- Patient requires retreatment
- 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 214

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