LDCY-MM study

JRCT ID: jRCTs031180336

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 02/09/2015
• Target sample size: 22
• 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

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
• 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) 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 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.

Related Information

• Primary Sponsor: Sakaida Emiko