Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiba University
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

1. Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)

2. Recurrent or refractory Crow-Fukase syndrome.

3. Patients without severe liver or renal dysfunction.

4. Patients without severe neutropenia or thrombocytopenia.

5. Patients without clinically problematic ECG findings

6. Negative on the pregnacy test on the day 1 of cycle 1.

7. Patients who can undertake prevention of pregnancy, if necessary.

8. Patients with written informed consent.

9. Patients who are capable of ambulatory hospital visits every 4 weeks.

10. Patients with informed consent to the registration and rules of RevMate®.

Exclusion Criteria:

1. Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.

2. Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.

3. Patients who have been administered bevacizumab within 12 weeks prior to the registration.

4. Patients who could worsen acutely during the clinical trial period.

5. Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.

6. Patients with malignancies.

7. Female patients who are pregnant or desire childbearing. Males who desire fertility.

8. Patients who allergic to lenalidomide or dexamethasone.