Unique ID issued by UMIN | UMIN000003043 |
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Receipt number | R000003684 |
Scientific Title | A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation |
Date of disclosure of the study information | 2010/01/25 |
Last modified on | 2012/01/26 20:55:58 |
A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation
A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation
A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation
A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation
Japan |
multiple myeloma
Hematology and clinical oncology |
Malignancy
NO
Evaluation of the efficacy and safety of bortezomib as maintenance therapy for multiple myeloma after autologous stem cell transplantation comparing with thalidomide therapy.
Safety,Efficacy
Response rate 1 year after stem cell transplantation
Response rate 2 and 3 year after stem cell transplantation.
Progression free survival, overall survival, and adverse events.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
2
Treatment
Medicine |
Bortezomib 1.3 mg/m2 iv., day 1,8,15,and 22. 6 courses in 35-day cycle.
Thalidomide 100 mg/day po. for 180days.
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with multiple myeloma who have recieved autologous hematopoietic stem cell transplantation for the first time within 3 months. (Including patients who will recieved autologous hematopoietic stem cell transplantation.)
2. Meet the guidelines for administration of Bortezomib at the start of the study treatment.
3. Clinical data at disease onset and before transplantation can be obtained.
4. Maintenance therapy can be started by 4 months after transplantation.
5. Written-informed consent has obtained.
1. Allergy for thalidomide, Bortezomib, mannitol,and boron.
2. A woman during pregnancy or potential pregnancy
3. Patients unable to comply with safety management procedures of thalidomide.
4. Patients who cannot stop drugs or therapy restricted in this trial.
5. Patients who are recognized as inadaptable for this trial.
200
1st name | |
Middle name | |
Last name | Mineo Kurokawa |
University of Tokyo Hospital
Hematology and Oncology
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
1st name | |
Middle name | |
Last name |
University of Tokyo Hospital
Hematology and Oncology
University of Tokyo Hospital,
Department of Hematology and Oncology
None
Self funding
NO
2010 | Year | 01 | Month | 25 | Day |
Unpublished
Completed
2009 | Year | 11 | Month | 04 | Day |
2010 | Year | 01 | Month | 01 | Day |
2010 | Year | 01 | Month | 15 | Day |
2012 | Year | 01 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003684
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