Unique ID issued by UMIN | UMIN000016265 |
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Receipt number | R000017324 |
Scientific Title | Phase II study evaluating safety and efficacy of induction therapy with small-dose bortezomib, lenalidomide and dexamethasone combination for previously untreated symptomatic multiple myeloma |
Date of disclosure of the study information | 2015/01/19 |
Last modified on | 2018/07/26 19:03:59 |
Phase II study evaluating safety and efficacy of induction therapy with small-dose bortezomib, lenalidomide and dexamethasone combination for previously untreated symptomatic multiple myeloma
HCHSG-MM-214
Phase II study evaluating safety and efficacy of induction therapy with small-dose bortezomib, lenalidomide and dexamethasone combination for previously untreated symptomatic multiple myeloma
HCHSG-MM-214
Japan |
Multiple Myeloma
Hematology and clinical oncology |
Malignancy
NO
Evaluating safety and efficacy of induction therapy with small-dose bortezomib, lenalidomide and dexamethasone combination for previously untreated symptomatic multiple myeloma
Safety,Efficacy
Response rate
Incidence of adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
<BD therapy; 1 course>
Dexamethasone 40 mg/day (day 1, 8, 15, 22) and subcutaneous injection of bortezomib 1.3 mg/m2/day (day 1, 15), one course in 28-day cycle.
<small BLD (sBLD) therapy; 12 courses>
Lenalidomide 10 mg day (day 1-21), dexamethasone 40 mg/day (day 1, 8, 15, 22) and subcutaneous injection of bortezomib 1.3 mg/m2/day (day 1, 15), 12 courses in 28-day cycle.
20 | years-old | <= |
Not applicable |
Male and Female
Previously untreated symptomatic multiple myeloma who are not candidates for stem cell transplantation.
Measureable M protein in serum or urine.
Good performance status (0-2). Patients with bad performance status due to osteolytic lesions can be included.
Age more than 20 years old.
Main Organ function is maintained.
Those who are evaluated to be able to survive more than 3 months.
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.
Non-secretory multiple myeloma or plasma cell leukemia.
HIV-, HBs-, or HCV-positive patients.
Severe or uncontrolled hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction, diabetes, hypertension, infection, or psychiatric disorder.
Patients with active and progressive malignancy.
Women who are pregnant or in lactation.
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
tsutomus@sapmed.ac.jp
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
tsutomus@sapmed.ac.jp
Sapporo Medical University Hospital
None
Self funding
NO
2015 | Year | 01 | Month | 19 | Day |
Unpublished
Completed
2015 | Year | 01 | Month | 19 | Day |
2015 | Year | 01 | Month | 19 | Day |
2015 | Year | 01 | Month | 19 | Day |
2018 | Year | 07 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017324
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