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Completed

NCT Number: NCT01816620

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

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

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Key information

Conditions

POEMS Syndrome Abnormalities, Multiple Blood Protein Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nervous System Diseases Neuromuscular Diseases Paraproteinemias Peripheral Nervous System Diseases Polyneuropathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must understand and voluntarily sign an informed consent form.
  • Older than 18 years old at the time of signing consent.
  • Meet the diagnostic criteria of POEM syndrome.
  • Must be cytotoxic treatment naive. However, previous or existing corticosteroid (prednisone or dexamethasone) or intravenous immunoglobin (IVIG) therapy is allowed.
  • 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.
  • Male subjects must agree to use condoms throughout study drug therapy.

Exclusion criteria

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or lactating females.
  • 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.

  • 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.
  • Known hypersensitivity or prior history of uncontrollable side effects to dexamethasone therapy.
  • Prior use of cytotoxic drugs.
  • Subjects who are unable or unwilling to undergo antithrombotic therapy.

Treatment and study plan

Lenalidomide, dexamethasone

Drug

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 names: Revlimid

Primary outcomes

  1. Hematological response rate

    Time frame: last day of the LDx treatment regimen (up to 9 months)

  2. Neurological response rate defined by ONLS score

    Time frame: last day of the LDx treatment regimen (up to 9 months)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. adverse events

    Time frame: throughout the treatment and until 30 days after the administration of the last dose of a study drug

  7. 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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Celgene Corporation

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Mar 22, 2013
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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