ovel Combinations for Orphan Myeloma: The NORM Platform Study
- Conditions
- Neoplasms
- Registration Number
- KCT0008451
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 140
1.Previous bortezomib therapy and either
•Failure to achieve at least a partial response during treatment or within 6 months of discontinuing treatment with bortezomib OR
•Progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib OR
•Contraindication or experienced an intolerance to treatment with bortezomib
2.Previous lenalidomide therapy and either
•Treatment failure with lenalidomide, as confirmed by progressive disease during treatment within 6 months of discontinuing lenalidomide
•A contraindication or intolerance to treatment with lenalidomide
1.Previous treatment with pomalidomide or selinexor
2.Contraindication to pomalidomide, selinexor or dexamethasone
3.Any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of trial treatment.
4.Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (CPGO) (NCCN CPGO) for antiemesis and anorexia/cachexia
(palliative care).
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS
- Secondary Outcome Measures
Name Time Method Best achieved disease response on novel agent(s