LDCY-POEMS study

JRCT ID: jRCTs031180421

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: POEMS syndrome
• Date of first enrollment: 15/08/2016
• Target sample size: 14
• Study type: Interventional
• Intervention(s): Treatment by cyclophosphamide, mesna, graniserton, and lenograstim. Autologous peripheral blood stem cell harvest (auto-PBSCH)

Outcome(s)

• Primary Outcome: Success rate of PBSCH to obtain 2 times10^6/kg CD34 positive cells for a transplantation
• Secondary Outcome: effectiveness Day of engraftment safetyFrequency of adverse events (any grade/grade 3 and more), frequency of adverse response against drugs

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both
• Include criteria: 1) Patients diagnosed with multiple myeloma based on IWMG criteria 2) Bone marrow plasma cells under 5% after chemotherapy 3) Lenalidomide treatment under 4 cycles 4) More than 4 weeks after the beginning day of the last chemotherapy 5) Age 20-70 6) Within 14 days prior to registration Neutrophil over 1,000/mm3 Hemoglobin over 8.0g/dlPlatelet over 100,000/mm3 GOT, GPT under 2.5 times the upper limit of normal level Total bilirubin under 2.0mg/dl Creatinine under 2.0mg/dl ECG WNL or trivial change without any symptoms SpO2 over 95% 7) More than 3 months survival expected 8) Informed consent obtained

Exclude criteria

1) Pregnant or lactating females. Patients who cannot do contraception.
2) Complications of active other cancers.
3) Severe psychological disorder
4) HBsAg positive or HBV-DNA positive.
5) HIV-Ab positive.
6) HCV-Ab positive.
7) Plasma cells in the peripheral blood.
8) Severe drug allergy.
9) Active infection.
10) Any other problems regarded as disqualification by doctors.

Related Information

• Primary Sponsor: Sakaida Emiko