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
- Conditions
- Patient with Relapsed or Relapsed-and-refractory Multiple MyelomaMMC90.0
- Registration Number
- LBCTR2019010183
- Lead Sponsor
- SecuraBio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9
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 randomization
Exclusion Criteria:
•primary refractory myeloma
•refractory to bortezomib
•concomitant anti-cancer therapy (other then BTZ/Dex and bisphosphonates
•prior treatment with DAC inhibitors
•Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months prior to randomization)
•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 inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: 1.Overall response rate (ORR) up to 8 cycles ;Timepoints: [ Time Frame: up to 8 cycles per patient, approximately 30 months ];Measure: up to 8 cycles
- Secondary Outcome Measures
Name Time Method ame: overall response rate ;Timepoints: through out study ;Measure: Through out the study;Name: Progression-free survival ;Timepoints: Progression free survival ;Measure: PFS