Single arm open-label trial to investigate the efficacy and safety of Lenlidomide as a treatment for recurrent or refractory Crow-Fukase (POEMS) syndrome.

Single arm open-label trial to investigate the efficacy and safety of Lenlidomide as a treatment for recurrent or refractory Crow-Fukase (POEMS) syndrome. - 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

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014493

Enrollment

Registered

2014-07-08

Start date

2014-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Crow-Fukase (POEMS) syndrome

Interventions

Cycle1 : Lenalidomide 15mg/day (day 1-21) Cycle2-6 : Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.) (2) Patients with 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

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

Contacts

Public ContactSonoko Misawa

Chiba University Graduate School of Medicine Department of Neurology

sonoko.m@mb.infoweb.ne.jp043-226-2129

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026