Unique ID issued by UMIN | UMIN000024165 |
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Receipt number | R000027823 |
Scientific Title | Efficacy and safety of new drugs for induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed symptomatic multiple myeloma: a phase 2 study |
Date of disclosure of the study information | 2017/02/01 |
Last modified on | 2017/10/05 09:51:26 |
Efficacy and safety of new drugs for induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed symptomatic multiple myeloma: a phase 2 study
JSCT-MM16
Efficacy and safety of new drugs for induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed symptomatic multiple myeloma: a phase 2 study
JSCT-MM16
Japan |
Multiple myeloma
Hematology and clinical oncology |
Malignancy
NO
The purpose of this study is to investigate efficacy and safety of new drugs in each phase of treatment in patients with newly diagnosed symptomatic multiple myeloma, and to investigate efficacy of detection of minimal residual disease (MRD).
Induction therapy: bortezomib, lenalidomide, and dexamethasone (VRD).
Conditioning regimen in autologous stem cell transplantation: bortezomib and high-dose melphalan.
Consolidation therapy: carfilzomib, lenalidomide, and dexamethasone (KRD).
Maintenance therapy: lenalidomide (until-PD).
Safety,Efficacy
Complete response (CR) rates after consolidation therapy.
1. CR + stringent CR (sCR) rates after induction therapy.
2. CR + sCR rates after autologous stem cell transplantation.
3. sCR rates after consolidation therapy.
4. CR + sCR rates after maintenance therapy.
5. 3-years progression free survival (PFS)
6. 3-years overall survival (OS)
7. 3-years Time to Treatment Failure (TTF)
8. Incidence of adverse events.
9. Molecular complete response (mCR) rates after autologous stem cell transplantation, consolidation and maintenance therapy.
10. Detection of minimal residual disease (MRD) in autologous grafts
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Induction therapy (4 courses, every 3 weeks)
scBor 1.3mg/m2 day1,4,8,11 + Len 25mg/body day1-14 + Dex 40mg/body day1,4,8,11
PBSC harvest
scBor 1.3mg/m2 day1,4,8,11 + CY 1.5g/m2 day8,9 + G-CSF
High dose chemotherapy and PBSCT
scBor 1.3mg/m2 day-4,-1,3,6 + HD-Mel 100mg/m2 day-3,-2 PBSCT day0
Consolidation therapy (4 courses, every 4 weeks)
Cfz 20/27mg/m2 day1,2,8,9,15,16 + Len 25mg/body day1-21 + Dex 40mg/body day1,8,15
Maintenance therapy (every 4 weeks until PD)
Len 10mg/day day1-21 until-PD
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1. Age from 20 to 65 years old.
2. Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG).
3. Measureable M protein in serum or urine or abnormal serum kappa/lambda ratio by the serum free light chain measurement.
4. Good performance status (0-2). (Patients with poor performance status by the osteolytic lesions can be included.)
5. Main Organ function is maintained
6. Those who are evaluated to be able to survive more than 3 months.
7. For female patients, postmenopausal (patients older than one year from the last menstrual period), or the proper way or surgical contraception (birth control pills, contraceptives, etc.) has the intention of contraception during the study according to the proposal of RevMate. For male patients, to agree the appropriate method of contraception during the study according to the proposal of RevMate.
8. 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 having been obtained.
1. Non-secretory MM, plasma cell leukemia, POEMS syndrome, and Waldenstrom Macroglobulinemia.
2. Patients with amyloidosis.
3. Patients who have been undergoing surgery or radiation treatment within 14 days before participating the study.
4. Patients who received prednisolone more than 30mg/day within 14 days before participation.
5. Involvement of central nervus system with myeloma cells
6. Patients HIV-positive, HBs antigen positive, and HCV antibody positive (except HCV-PCR negative).
7. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
8. Patients with a history of active malignancy during the past 5 years.
9. Patients with psychiatric disorders such as schizophrenia etc.
10. Pregnant women, pre-menopausal women, and lactating women.
11. History of hypersensitivity to mannitol or boron.
12. Patient was suspected pneumonia (Interstitial pneumonia). Consult a respiratory specialist if necessary
13. Those who are considered as inappropriate to register by attending physicians.
133
1st name | |
Middle name | |
Last name | Toshihiro Miyamoto |
Kyushu University Graduate School of Medical Science
Department of Medicine and Biosystemic Science
Fukuoka, Japan
092-
jsct-office@umin.ac.jp
1st name | |
Middle name | |
Last name | Toshihiro Miyamoto |
JSCT
MM16 DC
104-0031
03-6225-2025
jsct-office@umin.ac.jp
JSCT
CELGENE K.K.
ONO PHARMACEUTICAL CO., LTD.
Profit organization
NO
2017 | Year | 02 | Month | 01 | Day |
Unpublished
Open public recruiting
2016 | Year | 12 | Month | 01 | Day |
2017 | Year | 02 | Month | 01 | Day |
2016 | Year | 09 | Month | 26 | Day |
2017 | Year | 10 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027823
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