At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Karnofsky Performance Status (KPS) score ≥70%
- ✓Histologically confirmed multiple myeloma with relapsed or relapsed/refractory disease
- ✓Measurable disease: serum M-protein ≥0.5 g/dL, urine M-protein ≥200 mg/24 hours, or involved serum free light chain ≥10 mg/dL with abnormal ratio
- ✕Chemotherapy, biological, immunotherapy, or investigational agent within 14 days prior to study drug (7 days for targeted therapies like bortezomib/carfilzomib/lenalidomide/pomalidomide after recovery from toxicity); 6 weeks from nitrosourea; 12 weeks from BMT; 2 weeks from radiation
- ✕Grade >1 proteinuria (1 g/24 hour after subtracting M proteins), untreated urinary tract infection, or pre-existing kidney disease judged excessive risk
- ✕Evidence of mucosal or internal bleeding and/or platelet refractoriness (unable to maintain platelet count ≥30 × 10⁹/L)
- ✕Significant cardiac disease: congenital long QT syndrome, NYHA Class III-IV congestive heart failure, myocardial infarction or ischemia within 12 months, abnormal LVEF, or prior CTCAE Grade >3 hypersensitivity to propylene glycol or ethanol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating MRZ 0.5 mg/m^2 for Multiple Myeloma. Completed, enrolled 15 participants across 6 sites.
Detailed Summary
This is a Phase 2, open-label, multicenter study examining the safety, pharmacokinetics and pharmacodynamics, and best overall response to escalating doses of the proteasome inhibitor NPI-0052 (also known as marizomib) in patients with relapsed or relapsed/refractory multiple myeloma. NPI-0052 is a novel, second generation proteasome inhibitor that prevents the breakdown of proteins involved in signal transduction which blocks growth and survival in cancer cells. The study is a Phase 2 study and is a 2-stage efficacy design in a selected subgroup of patients (Arm C) treated with the recommended phase 2 dose of NPI-0052, as determined in a previously completed Phase 1 study. The study is to evaluate the safety and any preliminary evidence of efficacy of NPI-0052 in multiple myeloma patients who have previously received carfilzomib (PR-171, Kyprolis™) and subsequently had disease progression.
Study Details
Timeline
Interventions
NPI-0052 0.5 mg/m2 administered IV over 2 hours on Days 1, 4, 8, and 11 in each 21-day cycle