NCT02193698CompletedPhase 2
Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase (POEMS) Syndrome
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Chiba University
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Reduction rate of serum VEGF
Study Overview
Brief Summary
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.
Detailed Description
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent /refractory POEMS (Crow-Fukase) syndrome.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)
- •Recurrent or refractory Crow-Fukase syndrome.
- •Patients without severe liver or renal dysfunction.
- •Patients without severe neutropenia or thrombocytopenia.
- •Patients without clinically problematic ECG findings
- •Negative on the pregnacy test on the day 1 of cycle
- •Patients who can undertake prevention of pregnancy, if necessary.
- •Patients with written informed consent.
- •Patients who are capable of ambulatory hospital visits every 4 weeks.
- •Patients with informed consent to the registration and rules of RevMate®.
Exclusion Criteria
- •Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.
- •Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.
- •Patients who have been administered bevacizumab within 12 weeks prior to the registration.
- •Patients who could worsen acutely during the clinical trial period.
- •Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.
- •Patients with malignancies.
- •Female patients who are pregnant or desire childbearing. Males who desire fertility.
- •Patients who allergic to lenalidomide or dexamethasone.
Arms & Interventions
Lenalidomide+Dexamethasone
Experimental
Cycle1 : Lenalidomide 15mg/day (day 1-21) Cycle2-6 : Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)
Intervention: Lenalidomide+Dexamethasone (Drug)
Outcomes
Primary Outcomes
Reduction rate of serum VEGF
Time Frame: after 24 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Sonoko Misawa
Associate Professor
Chiba University
Study Sites (1)
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