YCUMM-1401:Efficacy of VRD and Lenalidomide therapy after autologous stem cell transplantation for multiple myeloma patients

UMIN ID: UMIN000014038

Registered date:01/06/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: multiple myeloma
• Date of first enrollment: 2014/06/01
• Target sample size: 19
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): bortezomib 1.3 mg/m2 s.c day1,8,15 lenalidomide 10 mg/body p.o. day1-21 dexamethasone 40 mg/body p.o. day1,8,15 repeat 4 times on every 28 days lenalidomide 10mg/body/day p.o. 21days every 28 days upto 2 years

Outcome(s)

• Primary Outcome: progression free survival
• Secondary Outcome: overall survival efficacy rate of VRD therapy completion rate of VRD therapy adverse event rate

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Patients who have allergic history for bortezomib, lenalidomide, or dexamethasone. 2. Patients who diagnosed with malignancy of plasma cell other than myekoma. 3. Patient who cannot expect to survive more than 3 months. 4. Patients who have other active malignancy within past 5 years 5. Patients with positivity of HBs antigen, HCV antibody, or HIV antibody. 6. Patients with periferal neuropathy of CTCAE Grade 2-4. 7. Patients with severe active infection. 8. Patients with severe mental disturbance. 9. Patient with severe respiratory impairment. 10. Patients with interstitial pneumonia or pulmonary fiblosis. 11. Patients with severe cardiac dysfunction 12. Patients with uncontroled diabetes mellitus. 13. Patients who need dialysis. 14. Patients with severe liver dysfunction 15. Patients with pregnant or lactating 16. Patients who are considerded unsuitable for the trial by attending physician.

Related Information

• Primary Sponsor: Yokohama City University
• Source(s) of Monetary Support: Yokohama City University