Single arm open-label trial to investigate the efficacy and safety of FPF300 as a remmision induction treatment for POEMS (Crow-Fukase) syndrome
- Conditions
- Crow-Fukase (POEMS) syndrome
- Registration Number
- JPRN-jRCT2091220135
- Lead Sponsor
- Chiba University hospital, department of neurology and clinical research center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
(1) Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria)
(2) Patients who wish to undergo high-dose chemotherapy with autologus stem cell transplantation
(3) Over 20 years old and less than 66 years old
(4) Patients wihtout severe liver or renal dysfunction on the screening test
(5) Patients who are capable of hospital admission at the time of startting clinical trial
(6) Patients who are capable of ambulatory hospital visits evry 4 weeks.
(7) Patients who have an clinicaly probrematic ECG
(8) Patients with written informed consent.
(9) Patients with informed consent to thalidomide education and risk management system
(1) Patients who have recieved thalidomide, lenalidomide, melpharan, or bortezomib within 4 weeks prior to the informed consent.
(2)Patients who have recieved bevacizumab within 12 weeks prior to the informed consent.
(3) Patients who have recieved systemic steroid administration (over than 10mg/day of predonisone)
(4) Pateints who could worsen acutely during the clinical trial period
(5) Females who are pregnant or desire childbearing. Males who desire fertility
(6) Patients who have severe complications (cardiac failure, renal failure, liver failure, bleedin ulcer, ileus, diabetes with poorly controlled hyperglycemia)
(7) Patients who have other malignancy (including myeloma or primary macroglobulinemia)
(8) Patients with past medical history of allergy to thalidomide or dexamethasone
(9) Patients with serious mental disorder
(10) Patients who have participated in other clinical trials within 12 weeks prior to the informed consent.
(11) Patients who have received drugs or therapy prohibited in the clinical trial within 4 weeks
(12) Patients who are not appropriate to participate to the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method adverse events during FPF300 administration<br>peripheral blood stem cell harvest
- Secondary Outcome Measures
Name Time Method Reducation rate of serum VEGF level (at the 24th week)<br>Serum VEGF level<br>Rate of complete remission achievement<br>Rate of partial remission achievement<br>Serum albumin level<br>M-protein (serum, immunofixation)<br>Motor function (muscle power/grip strength/ONLS)<br>Motor conduction velocity/CMAP amplitude/F-wave latency (median nerve)<br>Sensory condcution velocity/SNAP amplitude (median/sural nerve)<br>Pleural effusion<br>Vital capacity<br>Body weight<br>QOL(SF36)<br>Rate of the patients who complete the clinical trial