A single-arm, prospective phase 2 clinical study on the treatment of POEMS syndrome with low-frequency esatuximab combined with lenalidomide and dexamethasone regimen

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600128693

Enrollment

Unknown

Registered

2026-07-24

Start date

2026-08-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

POEMS syndrome

Interventions

Intervention group:The low-frequency extuximab combined with lenalidomide and dexamethasone regimen (the administration of extuximab is 10mg/kg, once every 2 weeks from the first to the fourth week, a

once every 8 weeks after achieving CRh and CRv. Lenalidomide: 10mg/25mg po d1-21

Dexamethasone 20mg is used in combination with essatuximab.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with POEMS syndrome; 2.Aged 18 to 70, gender not limited; 3.ECOG 0-3 score; 4.The patient (or their legal representative) signs the informed consent form, indicating their understanding of the purpose and process requirements of the study and their willingness to participate in it.

Exclusion criteria

Exclusion criteria: 1. Severe infectious diseases, including untreated tuberculosis, pulmonary aspergillosis, positive for human immunodeficiency virus (HIV), or active phase of hepatitis A, B, or C infection; or hepatitis B virus DNA copy number >10^4. 2. Severe organic damage to major organs, specifically: creatinine clearance 1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 times ULN; cardiac enzymes >2 times ULN, or echocardiography (ECHO) showing left ventricular ejection fraction <60%. 3. Epilepsy, dementia, or other psychiatric disorders requiring treatment, rendering the patient unable to understand or follow the study protocol. 4. Concurrent other malignancies; or expected survival <1 year. 5. Conditions that, in the investigator's opinion, make the subject unsuitable for enrollment.

Design outcomes

Primary

Measure	Time frame
Overall response rate ORR;Complete Remission (CRh and CRv);	—

Secondary

Measure	Time frame
Safety;Progression free survival,PFS;Overall survival,OS;Adverse event;	—

Countries

China

Contacts

Public ContactCai Zhen

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

caiz@zju.edu.cn+86 571 87235975

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026