Unique ID issued by UMIN | UMIN000008236 |
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Receipt number | R000009442 |
Scientific Title | Phase II study evaluating safety and efficacy of maintenance therapy with bortezomib, lenalidomide and dexamethasone for multiple myeloma |
Date of disclosure of the study information | 2012/06/22 |
Last modified on | 2014/12/22 09:27:05 |
Phase II study evaluating safety and efficacy of maintenance therapy with bortezomib, lenalidomide and dexamethasone for multiple myeloma
SMUIM4-MM01
Phase II study evaluating safety and efficacy of maintenance therapy with bortezomib, lenalidomide and dexamethasone for multiple myeloma
SMUIM4-MM01
Japan |
Multiple Myeloma
Hematology and clinical oncology |
Malignancy
NO
Evaluation of safety and efficacy of maintenance therapy with bortezomib, lenalidomide and dexamethasone for multiple myeloma.
Safety,Efficacy
Best response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
lenalidomide 10 mg day (day 1-21), dexamethasone 40 mg/day (day 1, 8, 15, 22), bortezomib 1.3 mg/m2/day (day 1, 15), 6 courses in 28-day cycle.
20 | years-old | <= |
80 | years-old | >= |
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.
30
1st name | |
Middle name | |
Last name | Tsutomu Sato |
Sapporo Medical University Hospital
Fourth Department of Internal Medicine
S-1, W-16, Chuo-ku, Sapporo
011-611-2111
1st name | |
Middle name | |
Last name |
Sapporo Medical University Hospital
Fourth Department of Internal Medicine
S-1, W-16, Chuo-ku, Sapporo
011-611-2111
Fourth Department of Internal Medicine, Sapporo Medical University Hospital
None
Self funding
NO
2012 | Year | 06 | Month | 22 | Day |
Unpublished
Completed
2012 | Year | 05 | Month | 31 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 22 | Day |
2014 | Year | 12 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009442
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