Thalidomide Treatment for Crow Fukase (POEMS) Syndrome: A Multicenter, Randomized, Double blind, Placebo controlled, Parallel group Trial with an Extension Phase to Evaluate the Long term Safety

Thalidomide Treatment for Crow Fukase (POEMS) Syndrome: A Multicenter, Randomized, Double blind, Placebo controlled, Parallel group Trial with an Extension Phase to Evaluate the Long term Safety - J - POST Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004179

Enrollment

Registered

2010-09-10

Start date

2010-11-11

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 100-300mg/day FPF300-palacebo 100-300mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria) (2) Over 20 years old (3) Patients whose ECOG Performance Status not exceeding 3 (4) Patients whose overall neuropathy limitaion scale not exceeding 9 (5) Patients whose liver function test and renal function test are within below limits. AST (GOT) smaller than 4.0 X upper limit of normal ALT (GPT) smaller than 4.0 X upper limit of normal Creatinine smaller than 1.5 X upper limit of normal (6) Patients who are capable of undergoing in hospital examinations at the time of starting and quitting the trial. (7) Patients who are capable of ambulatory hospital visits. (8) Patients who have an clinicaly probrematic ECG (9) Patients with written informed consent. (10) Patients who are not candidates for high dose chemotherapy with autologous stem cel rescue (11) Patients with informed consent to thalidomide education and risk management system

Exclusion criteria

Exclusion criteria: (1) Patients who have recieved thalidomide, melpharan, or bortezomib within 24 weeks prior to the informed consent. (2) Pateints who could worsen acutely during the clinical trial period (3) Patients who have recieved oral or intravenous administration of steroid (not including inhalant) within 4 weeks of providing informed consent. (4) Females who are pregnant or desire childbearing. Males who desire fertility (5) Patients who have severe complications (cardiac failure, renal failure, liver failure, bleedin ulcer, ileus, diabetes with poorly controlled hyperglycemia) (6) Patients who have other malignancy (7) Patients with past medical history of allergy to thalidomide or dexamethasone (8) Patients with serious mental disorder (9) Patients who have participated in other clinical trials within 12 weeks prior to the informed consent. (10) Patients who have received drugs or therapy prohibited in the clinical trial within 4 weeks (11) Patients who are not appropriate to participate to the trial

Design outcomes

Primary

Measure	Time frame
Reduction rate of serum VEGF level at 24 weeks	—

Countries

Japan

Contacts

Public ContactSonoko Misawa

Chiba University, Graduate School of Medicine Department of Neurology

sonoko.m@mb.infoweb.ne.jp043-222-7171

Outcome results

None listed

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