Unique ID issued by UMIN | UMIN000007880 |
---|---|
Receipt number | R000009276 |
Scientific Title | To investigate the efficacy and safety of bortezomib as maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation |
Date of disclosure of the study information | 2012/05/02 |
Last modified on | 2016/12/03 20:25:07 |
To investigate the efficacy and safety of bortezomib as maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation
Kanshinetsu MMG-002
To investigate the efficacy and safety of bortezomib as maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation
Kanshinetsu MMG-002
Japan |
Multiple myeloma
Hematology and clinical oncology |
Malignancy
NO
To investigate the efficacy and safety of bortezomib-based induction therapy followed by bortezomib maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation.
Safety,Efficacy
progression-free survival
Incidents of adverse events during maintenance therapy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Bortezomib-based induction therapy followed by bortezomib maintenance therapy (1.3mg/m2) in every 2 weeks for one year.
20 | years-old | <= |
Not applicable |
Male and Female
1. Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG).
2. Measureable M protein in serum or urine.
3. Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.)
4. Age more than 20 years old.
5. Main Organ function is maintained
6. Those who are evaluated to be able to survive more than 3 months.
7. In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained.
1. Non-secretory MM and plasmacell leukemia.
2. Patients HIV-HBs-and HCV-positive
3. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
4. Patients with a history of active malignancy during the past 5 years.
5. Patients with psychiatric disorders such as schizophrenia etc.
6. History of hypersensitivity to mannitol or boron.
7. Patient was suspected pneumonia(Interstitial pneumonia). Consult a respiratory specialist if necessary
8. Those who are considered as inappropriate to register by attending physicians.
35
1st name | |
Middle name | |
Last name | Hirokazu Murakami |
Gunma Graduate School of Health Scineces
Department of Laboratory Sciences,
3-39-22 Showa-machi, Maebashi-shi, Gunma
1st name | |
Middle name | |
Last name | Atsushi Isoda |
NHO National Nishigunma Hospital
Department of Internal Medicine
2854 Kanai, Shibukawa-shi, Gunma
0279-23-3030
Kanshinetsu Multiple Myeloma Group
None
Self funding
NO
2012 | Year | 05 | Month | 02 | Day |
Unpublished
No longer recruiting
2012 | Year | 03 | Month | 05 | Day |
2012 | Year | 05 | Month | 01 | Day |
2016 | Year | 08 | Month | 31 | Day |
2016 | Year | 08 | Month | 31 | Day |
2012 | Year | 05 | Month | 02 | Day |
2016 | Year | 12 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009276