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POEMS SyndromePhase 2NCT01816620

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

A Phase 2 study testing Lenalidomide, Dexamethasone in people with POEMS Syndrome, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
POEMS Syndrome
What is being tested?
Lenalidomide, Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteChina
Study dates
Mar 2014to Apr 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100005

Other trials in China

About this study

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

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

Read the 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.

Conditions
POEMS Syndrome
Being tested
Lenalidomide, Dexamethasone
Keywords
POEMS Syndrome, lenalidomide, newly diagnosed, plasma cell disorder, Dexamethasone
Medical subject headings
POEMS Syndrome, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lenalidomide, DexamethasoneDrug

    Also called Revlimid

    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.

Study groups in NCT01816620
Study groupRoleWhat they receive
Lenalidomide, dexamethasoneExperimentalLenalidomide 10mg qd d1-21 \& dexamethasone 40mg qw d1,8,15,22
Receives: Drug: Lenalidomide, Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematological response rate

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

  2. Neurological response rate defined by ONLS score

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

Secondary outcomes (7)

  1. response rate of critical organs

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionOct 2015
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01816620
Sponsor's protocol ID
POEMS-01
Status last verified
Apr 2017
First submitted
14 Mar 2013
Last updated
25 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Gao Y, Zhang S, Yang L, Li J, Liu Y, Wang T. Skin Responses in Newly Diagnosed Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Gammopathy, and Skin Changes (POEMS) Syndrome After Therapy With Low-Dose Lenalidomide Plus Dexamethasone. Front Immunol. 2021 May 6;12:681360. doi: 10.3389/fimmu.2021.681360. eCollection 2021.

    PubMed 34025681

  • Liu LS, Zhang X, Zhao H, Gao XM, Zhou DB, Dai RP, Li J. Reliability of optic disc edema area in estimating the severity of papilledema in patients with POEMS syndrome. Orphanet J Rare Dis. 2020 May 19;15(1):116. doi: 10.1186/s13023-020-01392-x.

    PubMed 32429967

  • 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.

    PubMed 29603764

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide, Dexamethasone in people with POEMS Syndrome, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematological response rate (time frame: last day of the LDx treatment regimen (up to 9 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01816620, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.

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