Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial

Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase (POEMS) Syndrome

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02193698

Enrollment

Registered

2014-07-18

Start date

2014-07-31

Completion date

2016-04-30

Last updated

2016-07-29

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

Conditions

POEMS Syndrome

Keywords

POEMS syndrome, lenalidomide

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.

Interventions

DRUGLenalidomide+Dexamethasone

Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.) 2. Recurrent or refractory Crow-Fukase syndrome. 3. Patients without severe liver or renal dysfunction. 4. Patients without severe neutropenia or thrombocytopenia. 5. Patients without clinically problematic ECG findings 6. Negative on the pregnacy test on the day 1 of cycle 1. 7. Patients who can undertake prevention of pregnancy, if necessary. 8. Patients with written informed consent. 9. Patients who are capable of ambulatory hospital visits every 4 weeks. 10. Patients with informed consent to the registration and rules of RevMate®.

Exclusion criteria

1. Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration. 2. Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration. 3. Patients who have been administered bevacizumab within 12 weeks prior to the registration. 4. Patients who could worsen acutely during the clinical trial period. 5. Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes. 6. Patients with malignancies. 7. Female patients who are pregnant or desire childbearing. Males who desire fertility. 8. Patients who allergic to lenalidomide or dexamethasone.

Design outcomes

Primary

Measure	Time frame
Reduction rate of serum VEGF	after 24 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026