Unique ID issued by UMIN | UMIN000009668 |
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Receipt number | R000011341 |
Scientific Title | Phase I study of a B-HDM regimen for elderly multiple myeloma patients |
Date of disclosure of the study information | 2013/01/01 |
Last modified on | 2019/04/25 13:49:01 |
Phase I study of a B-HDM regimen for elderly multiple myeloma patients
B-HDM regimen
Phase I study of a B-HDM regimen for elderly multiple myeloma patients
B-HDM regimen
Japan |
Multiple Myeloma
Hematology and clinical oncology |
Malignancy
NO
To investigate the safety of B-HDM before ASCT in elderly Japanese patients with MM
Safety
Exploratory
Phase I
safty
efficacy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
B-HDM
65 | years-old | <= |
70 | years-old | > |
Male and Female
According to the International Myeloma Working Group (IMWG) criteria20, patients younger than 70 years with symptomatic MM were eligible for this trial.
The exclusion criteria were a serum creatinine level<2.05 mg/dL at time of high-dose therapy (HDT), liver dysfunction (e.g., a serum total bilirubin level<2.0 mg/dL, or serum aspartate/alanine aminotransferase or alkaline phosphatase levels more than 2.5 times the upper limit of normal), grade 3 or worse peripheral neuropathy, significant comorbidity that would preclude ASCT, poor performance status (grade 3), and a history of any other malignancy with the exception of basal cell carcinoma and stage I cervical cancer.
12
1st name | |
Middle name | |
Last name | Naoki Takezako |
National Hospital Organization Disaster Medical Center of Japan
Department of Hematology
3256 Midori-cho, Tachikawa-shi
042-526-5511
ntakezak@gmail.com
1st name | |
Middle name | |
Last name | Naoki Takezako |
National Hospital Organization Disaster Medical Center of Japan
Department of Hematology
3256 Midori-cho, Tachikawa-shi
042-526-5511
ntakezak@tdmc.hosp.go.jp
National Hospital Organization Disaster Medical Center of Japan
none
Self funding
NO
2013 | Year | 01 | Month | 01 | Day |
Unpublished
Completed
2012 | Year | 12 | Month | 20 | Day |
2012 | Year | 12 | Month | 22 | Day |
2013 | Year | 01 | Month | 04 | Day |
2018 | Year | 12 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2012 | Year | 12 | Month | 30 | Day |
2019 | Year | 04 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011341
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