Panobinostat with bortezomib and dexamethasone in relapsed or relapsed-and-refractory multiple myeloma

Phase 1

• Conditions: Multiple Myeloma; MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001564-19-CZ
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-05
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

- Multiple Myeloma as per IMWG 2014 definition
- Requiring treatment for relapsed or relapsed/refractory disease
- Measurable disease based on central protein assessment
- 1 to 4 prior lines of therapy
- Prior IMiD exposure
- Acceptable lab values prior to starting study treatment

Other protocol-defined inclusion criteria may apply.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 190

Exclusion Criteria

- Primary refractory myeloma
- Refractory to bortezomib i.e. patients who progressed while receiving salvage therapy with BTZ, or patients who progressed within 60 days of their most recent BTZ containing treatment.
- Concomitant anti-cancer therapy (other than BTZ/Dex and bisphosphonates)
- Prior treatment with DAC inhibitors
- Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 month prior to screening)
- Unresolved diarrhea = CTCAE grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease)

Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): - ORR (according to IMWG criteria by IRC assessment) comprised of<br>immunophenotypic CR (iCR), stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR);Timepoint(s) of evaluation of this end point: approximately after 30 months;Secondary Objective: - To assess overall response rate (ORR)<br>- To assess the individual iCR, sCR, CR, VGPR rates<br>- To assess progression free survival (PFS)<br>- To assess overall survival (OS)<br>- To evaluate overall safety of the combination of PAN, BTZ and Dex<br>- To assess pharmacokinetics<br>- To assess exposure-response (efficacy and safety) relationship<br>- To assess Time to Progression (TTP), Time to Response (TTR), Duration of Response (DOR)<br>- To assess health-related quality of life (HRQoL);Main Objective: - To assess overall response rate (ORR) up to 8 cycles