NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180336

Registered date:18/03/2019

LDCY-MM study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedMultiple myeloma
Date of first enrollment02/09/2015
Target sample size22
Countries of recruitment
Study typeInterventional
Intervention(s)Treatment by cyclophosphamide, mesna, graniserton, and lenograstim. Autologous peripheral blood stem cell harvest (auto-PBSCH)

Outcome(s)

Primary OutcomeSuccess rate of PBSCH to obtain 2 times10^6/kg CD34 positive cells for a transplantation
Secondary Outcomeeffectiveness Day of engraftment safety Frequency 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
GenderBoth
Include criteria1) 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
Exclude criteria1) 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.

Related Information

Contact

Public contact
Name Shio Mitsukawa
Address 1-8-1 Inohana, Chuo-ku, Chiba Chiba Japan 260-8670
Telephone +81-43-222-7171
E-mail shio-sakai@chiba-u.jp
Affiliation Department of Hematology, Chiba University Hospital
Scientific contact
Name Emiko Sakaida
Address 1-8-1 Inohana, Chuo-ku, Chiba Chiba Japan 260-8670
Telephone +81-43-222-7171
E-mail esakaida@faculty.chiba-u.jp
Affiliation Department of Hematology, Chiba University Hospital