A multicenter, randomized, open-label Phase 2 study evaluating the safety and efficacy of three different regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who have been previously exposed to immunomodulatory agents

Phase 2

Recruiting

• Conditions: Kahler's disease; Multiple Myeloma; 10025320

• Registration Number: NL-OMON50473
• Lead Sponsor: Secura Bio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2023-12-15
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

- Previous diagnosis of Multiple Myeloma based on IMWG 2014 definition, see
protocol page 36 for details
- Measurable disease based on protein assessment. Definition see protocol page
37.
- 1 to 4 prior lines of therapy. Present requirement for re-treatment of
relapsed myeloma or relapsed-and-refractory myeloma. Definitions: see protocol
page 36
- Prior IMiD exposure (thalidomide, lenalidomide and/or pomalidomide)
- ECOG performance status 0-1-2.
- >= 18 years old
- Measurable disease based on central lab assessment at screening
- Acceptable lab values prior to starting study treatment, see protocol page 37
for details

Exclusion Criteria

• Primary refractory myeloma. See protocol page 38 for details.
• Refractory to bortezomib.
• Any concomitant anti-cancer therapy (other than BTZ/Dex; bisphosphonates are
permitted
only if commenced prior to the start of screening period).
• Unresolved diarrhea >= CTCAE grade 2 or presence of medical condition
associated with
chronic diarrhea.
• Allogeneic stem cell transplantation with graft versus host disease either
active or requiring
immunosuppression.
• Grade >= 2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on
clinical
examination at screening.
• Prior treatments: see protocol page 38-39 for details (DAC inhibitors,
anti-myeloma
chemotherapy, biologicals, stem cell transplantation).
• Major surgery within 2 weeks.
• Uncontrolled heart disease and recent cardiac events. Other uncontrolled
conditions. See
protocol page 39 for details.
• HIV, hepatitis B-C: activity or history.
• Pregnancy, lactation, insufficient contraception for females of childbearing
potential.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>ORR up to cycle 8.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>ORR, CR, VGPR, PFS, OS, safety, PK, exposure-response relationship, TTP, TTR,<br /><br>DOR, QoL.</p><br>