Japanese POEMS syndrome with thalidmaide trial for compassionate use

Japanese POEMS syndrome with thalidmaide trial for compassionate use - Japanese POEMS syndrome with thalidmaide trial for compassionate use (JPOST15)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018660

Enrollment

Registered

2015-08-17

Start date

2015-08-17

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

FPF300 (thalidomide)100-300mg/day,at bedtime +Dexamethasone 20mg/day (day1-4) Duration:until the approval of thalidomide for POEMT syndrome

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria) (2) Patients aged 20 and older (3) Patients without severe liver or renal dysfunction (4) Patients without clinicaly probrematic ECG findings or severe bradycardia which require treatment. (5) Patients with written informed consent (6) Patients with informed consent to thalidomide education and risk management system

Exclusion criteria

Exclusion criteria: (1) Patients with the complication which leading to a high risk of severe adversed event by thalidomide (Absolute neutrophil count < 1000, Platelet count< 50000, repeated ileus,severe cardiac arrhythmias) (2) Female patients who are pregnant, desire childbearing or breastfeeding (3) Males patients who desire fertility. (4) Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes) (5) Patients who allergic to thalidomide (6) Patients with severe phychiatric disorders (7) Patients who has been participated any other clinical trial (8)Patients who are not appropriate to participate to the trial

Design outcomes

Primary

Measure	Time frame
Safety:Adverse event during FPF300 treatment Efficacy:Overall survival	—

Secondary

Measure	Time frame
1.Serum VEGF level 2.Motor function(Manual Muscle Test, grip strength,ONLS) 3.Median nerve conducton study (conduction velocity, CMAP amplitude, F-wave latency, SNAP amplitudes), Sural nerve conduction study (SNAP amlitudes and conduction velocity) 4.M protein (immunofixation) 5. Pleural effusion 6. Body weight	—

Countries

Japan

Contacts

Public ContactKanako Katayama

Chiba University Hospital Clinical research center

katayama-k@umin.net0432227171

Outcome results

None listed

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