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

NCT02193698 | Completed Phase 2 DMC

• 1 other identifier: G26007
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

POEMS Syndrome

Keywords

POEMS syndrome; lenalidomide

Outcome Measures

Primary Outcomes (1)

• Reduction rate of serum VEGF

  after 24 weeks

Study Arms (1)

Lenalidomide+Dexamethasone

EXPERIMENTAL

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

Drug: Lenalidomide+Dexamethasone

Interventions

Lenalidomide+Dexamethasone DRUG

Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)

Also known as: Lebramide+Decadoron

Lenalidomide+Dexamethasone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)
• Recurrent or refractory Crow-Fukase syndrome.
• Patients without severe liver or renal dysfunction.
• Patients without severe neutropenia or thrombocytopenia.
• Patients without clinically problematic ECG findings
• Negative on the pregnacy test on the day 1 of cycle 1.
• Patients who can undertake prevention of pregnancy, if necessary.
• Patients with written informed consent.
• Patients who are capable of ambulatory hospital visits every 4 weeks.
• Patients with informed consent to the registration and rules of RevMate®.

You may not qualify if:

• Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.
• Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.
• Patients who have been administered bevacizumab within 12 weeks prior to the registration.
• Patients who could worsen acutely during the clinical trial period.
• Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.
• Patients with malignancies.
• Female patients who are pregnant or desire childbearing. Males who desire fertility.
• Patients who allergic to lenalidomide or dexamethasone.

Sponsors & Collaborators

• Chiba University: lead

Study Sites (1)

Chiba University Graduate School of Medicine Department of neurology

Chiba, Chiba, 260-8760, Japan

Location

MeSH Terms

Conditions

POEMS Syndrome

Condition Hierarchy (Ancestors)

Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sonoko Misawa, MD

  Chiba University, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

JP (1)