Crow-Fukase (POEMS)syndrome
Conditions
Sponsors
J-POST Clinical Trial Office
Hokkaido University, Hokkaido Medical Center, Tohoku University, Chiba University, Saitama Medical University, Niigata University, Shinshu University, Nagoya University, Kinki University, Kobe City Medical Center General Hospital, Yamaguchi University, Kyushu University, Kagoshima University
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) (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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum VEGF level Achievement of targeted value (< 1000 pg/ml) of serum VEGF level Clinical scores (MMT, grip, overall neuropathy limitation scale) Nerve conducton study (conduction velocity, CMAP amplitude, F-wave latency) M-protein (serum and urine) pleural effusion vital capacity body weight QOL (SF-36) | — |
Countries
Japan
Contacts
Public ContactSonoko Misawa
Chiba University, Graduate School of Medicine
Outcome results
None listed