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Novel Combinations for Orphan Myeloma: The NORM Platform Study

Novel Combinations for Orphan Myeloma: The NORM Platform Study

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0008451
Enrollment
140
Registered
2023-05-19
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Selinexor 60mg PO Weekly* Pomalidomide 4mg PO Day 1-21* Dexamethasone Take with food 40mg PO in the a.m. Weekly *Dosed after dialysis for patients on haemodialysis

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
PFS

Secondary

MeasureTime frame
Best achieved disease response on novel agent(s

Countries

Korea, Republic of

Contacts

Public Contactkihyun kim

Samsung Medical Center

kihyunk@skku.edu+82-2-2148-7275

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026