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Trial record 6 of 374 for:    LENALIDOMIDE AND Dexamethasone

Study to Evaluate Lenalidomide Plus Dexamethasone in Patients With Newly Diagnosed POEMS Syndrome

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ClinicalTrials.gov Identifier: NCT01816620
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Jian Li, Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE March 14, 2013
First Posted Date  ICMJE March 22, 2013
Last Update Posted Date April 25, 2017
Actual Study Start Date  ICMJE March 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2013)
  • Hematological response rate [ Time Frame: last day of the LDx treatment regimen (up to 9 months) ]
  • Neurological response rate defined by ONLS score [ Time Frame: last day of the LDx treatment regimen (up to 9 months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01816620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2013)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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) ]
  • 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) ]
  • adverse events [ Time Frame: throughout the treatment and until 30 days after the administration of the last dose of a study drug ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2013)
  • 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 ]
  • 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 ]
  • Time to initial neurological response and 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 ]
  • 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) ]
  • 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) ]
  • adverse events [ Time Frame: throughout the treatment and until 30 days after the administration of the last dose of a study drug ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Lenalidomide Plus Dexamethasone in Patients With Newly Diagnosed POEMS Syndrome
Official Title  ICMJE An Open-label Phase II Study to Determine the Efficacy and Safety of Lenalidomide Plus Dexamethasone (LDex) in Patients With Newly Diagnosed POEMS Syndrome
Brief Summary The purpose of this prospective study is to determine the efficacy and safety of lenalidomide plus dexamethasone in patients with newly diagnosed POEMS syndrome.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE POEMS Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Lenalidomide, dexamethasone
Lenalidomide 10mg qd d1-21 & dexamethasone 40mg qw d1,8,15,22
Intervention: Drug: Lenalidomide, Dexamethasone
Publications * Li J, Huang XF, Cai QQ, Wang C, Cai H, Zhao H, Zhang L, Cao XX, Gale RP, Zhou DB. A prospective phase II study of low dose lenalidomide plus dexamethasone in patients with newly diagnosed polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome. Am J Hematol. 2018 Jun;93(6):803-809. doi: 10.1002/ajh.25100. Epub 2018 Apr 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2014)
41
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2013)
50
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01816620
Other Study ID Numbers  ICMJE POEMS-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jian Li, Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Jian Li, M.D. Peking Union Medical College Hospital
Study Director: Dao-bin Zhou, MD Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP