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
- Conditions
- Crow-Fukase (POEMS)syndrome
- Registration Number
- JPRN-UMIN000004179
- Lead Sponsor
- Chiba University, Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction rate of serum VEGF level at 24 weeks
- Secondary Outcome Measures
Name Time Method