Multiple myeloma Multiple myeloma
Conditions
Interventions
Treatment by cyclophosphamide, mesna, graniserton, and lenograstim. Autologous peripheral blood stem cell harvest (auto-PBSCH)
PBSCH, cyclophosphamide, lenograstim
Sponsors
Sakaida Emiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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) ECOG PS 0-2 7) Within 14 days prior to registration Neutrophil over 1,000/mm3 Hemoglobin over 8.0g/dl Platelet 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% 8) More than 3 months survival expected 9) Informed consent obtained
Exclusion criteria
Exclusion 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) Plasma cells in the peripheral blood. 7) Severe drug allergy. 8) Active infection. 9) Any other problems regarded as disqualification by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of PBSCH to obtain 2 times10^6/kg CD34 positive cells for a transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| effectiveness Day of engraftment safety Frequency of adverse events (any grade/grade 3 and more), frequency of adverse response against drugs | — |
Contacts
Public ContactShio Mitsukawa
Department of Hematology, Chiba University Hospital
Outcome results
None listed