UMIN ID: UMIN000014038
Registered date:01/06/2014
YCUMM-1401:Efficacy of VRD and Lenalidomide therapy after autologous stem cell transplantation for multiple myeloma patients
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 |
Include criteria | |
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 |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | Yokohama City University |
Secondary ID(s) |
Contact
public contact | |
Name | Etsuko Yamazaki |
Address | 3-9 Fukuura Kanazawa-ku, Yokohama Japan |
Telephone | 045-787-2800 |
etsukoy@yokohama-cu.ac.jp | |
Affiliation | Yokohama City University Hospital Clinical Laboratory Department |
scientific contact | |
Name | Etsuko Yamazaki |
Address | 3-9 Fukuura Kanazawa-ku, Yokohama Japan |
Telephone | 045-787-2800 |
etsukoy@yokohama-cu.ac.jp | |
Affiliation | Yokohama City University Hospirtal Clinical Laboratory Department |