Phase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSF

Phase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSF - Phase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSF

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018385

Enrollment

Registered

2015-07-22

Start date

2015-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

POEMS syndrome

Interventions

This study is composed of the following two steps of therapy. 1)PBSC mobilization using low dose cyclophosphamide and G-CSF 2)autologous peripheral stem cell transplantation after high dose chemot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with POEMS syndrome (confirmed by diagnostic criteria) 2)The plasma cell in bone marrow counts <= 5% 3) Previous trearments with lenalidomide <= 4 courses 4) Patients who have the latest treatment more than 2 weeks before enrollment 5)age >=20 and <= 70 6) Patients who have the following laboratory values within 14 days before enrollment .neutrophil count >= 1000/mm3 . Hemoglobin>=8.0g/dl . platelet count >= 100,000/mm3 . ALT <= 2.5 x upper limit of normal AST <= 2.5 x upper limit of normal . serum total bilirubin <= 2.0mg/dl . serum creatinine <= 2.0mg/dl . Normal ECG or asymptomatic minor ECG change . SpO2>=95% 7) Patients who are expected to survive more than 3 months 8) voluntary written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with plasma cells in CBC 2) Pregnant or nursing women. Patients reuse to contraception during examination period 3) Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment. 4) Patients with serious mental disorders 5) Patients with HBs antigen-positive 6) Patients with HIV antibody-positive 7) Patients with a history of severe allergy to the drugs 8) Patients with serious active infection 9) Patients who are determined to be inappropriate for this study by physicians

Design outcomes

Primary

Measure	Time frame
Patients collecting >= 2*10^6 CD34+ cells/kg on day 1 (%)	—

Secondary

Measure	Time frame
Safety Effect of this regimen on engraftment Incidence of adverse events (Grade 3) The day of first apheresis	—

Countries

Japan

Contacts

Public ContactShio Sakai

Chiba University Hospital Department of Transfusion Medicine and Cell Therapy

shio-sakai@chiba-u.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026