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

Chiba University

Status and phase: Completed; Phase 2

Conditions: POEMS Syndrome

Treatments: Drug: Lenalidomide+Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02193698

G26007

Details and patient eligibility

About

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

Full description

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

Enrollment: 5 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Lenalidomide+Dexamethasone

Experimental group

Description:

Cycle1 : Lenalidomide 15mg/day (day 1-21) Cycle2-6 : Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)

Treatment:

Drug: Lenalidomide+Dexamethasone