Trial record 1 of 4 for:    "POEMS syndrome"
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Study to Evaluate Lenalidomide Plus Dexamethasone in Patients With Newly Diagnosed POEMS Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Peking Union Medical College Hospital
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Jian Li, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01816620
First received: March 14, 2013
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

The purpose of this prospective study is to determine the efficacy and safety of lenalidomide plus dexamethasone in patients with newly diagnosed POEMS syndrome.


Condition Intervention Phase
POEMS Syndrome
Drug: Lenalidomide, Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Phase II Study to Determine the Efficacy and Safety of Lenalidomide Plus Dexamethasone (LDex) in Patients With Newly Diagnosed POEMS Syndrome

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Hematological response rate [ Time Frame: last day of the LDx treatment regimen (up to 9 months) ] [ Designated as safety issue: No ]
  • Neurological response rate defined by ONLS score [ Time Frame: last day of the LDx treatment regimen (up to 9 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate of critical organs [ Time Frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months ] [ Designated as safety issue: No ]
  • Response rate of serum vascular endothelial growth factor (VEGF) level [ Time Frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months ] [ Designated as safety issue: No ]
  • Time to initial neurological response [ Time Frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From date of first diagnosis until the date of death from any cause, otherwise patients will be censored in June, 2018 (up to 5 years) ] [ Designated as safety issue: No ]
  • Relapse free survival [ Time Frame: From date of first diagnosis until the date of first documented relapse or date of death from any cause, whichever came first, otherwise patients will be censored in June, 2018 (up to 5 years) ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: throughout the treatment and until 30 days after the administration of the last dose of a study drug ] [ Designated as safety issue: Yes ]
  • time to the best neurological response [ Time Frame: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: March 2014
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide, dexamethasone
Lenalidomide 10mg qd d1-21 & dexamethasone 40mg qw d1,8,15,22
Drug: Lenalidomide, Dexamethasone

12 cycles of lenalidomide and dexamethasone, each cycle lasts 28 days. For patients with Ccr equal to or higher than 30ml/min, oral lenalidomide 10mg once daily for days 1-21 out of a 28 cycle.

For patients with Ccr lower than 30ml/min, oral lenalidomide 10mg once every other day for days 1-21 out of a 28 cycle.

All the patients take Dexamethasone orally 40mg once weekly for day 1,8,15,22 out of a 28 cycle.

Other Name: Revlimid

Detailed Description:

The investigators propose to use the adverse effects as well as the need for dose reduction as a criterion to judge tolerability of treatment.

The primary endpoint would be hematological response rate according to international myeloma working group (IMWG) response criteria for amyloidosis and neurological response rate defined by overall neuropathy limitation scale (ONLS) score.

This study expects to enroll approximately 41 subjects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must understand and voluntarily sign an informed consent form.
  2. Older than 18 years old at the time of signing consent.
  3. Meet the diagnostic criteria of POEM syndrome.
  4. Must be cytotoxic treatment naive. However, previous or existing corticosteroid (prednisone or dexamethasone) or intravenous immunoglobin (IVIG) therapy is allowed.
  5. Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.
  6. Male subjects must agree to use condoms throughout study drug therapy.

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or lactating females.
  3. Any of the following laboratory abnormalities:

    Absolute neutrophil count(ANC) of<1.0×10E9 cell/L. Platelet count<50×10E9 cell/L. Renal failure requiring dialysis. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times of the normal upper limit.

  4. Prior history of malignancies, but not including basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and T1a or T1b prostate cancer.
  5. Known hypersensitivity or prior history of uncontrollable side effects to dexamethasone therapy.
  6. Prior use of cytotoxic drugs.
  7. Subjects who are unable or unwilling to undergo antithrombotic therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816620

Contacts
Contact: Jian Li, M.D. pumch.li.jian@gmail.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100005
Contact: Jian Li, M.D.       pumch.li.jian@gmail.com   
Principal Investigator: Dao-bin Zhou, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Celgene Corporation
Investigators
Principal Investigator: Jian Li, M.D. Peking Union Medical College Hospital
Study Director: Dao-bin Zhou, MD Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Jian Li, Associate professor of Hematology Department, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01816620     History of Changes
Other Study ID Numbers: POEMS-01
Study First Received: March 14, 2013
Last Updated: July 8, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Peking Union Medical College Hospital:
POEMS Syndrome
lenalidomide
newly diagnosed
plasma cell disorder
Dexamethasone

Additional relevant MeSH terms:
POEMS Syndrome
Syndrome
Disease
Pathologic Processes
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 30, 2014