Unique ID issued by UMIN | UMIN000026936 |
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Receipt number | R000030818 |
Scientific Title | Feasibility and efficacy of extended VRd as induction for transplant-eligible NDDM |
Date of disclosure of the study information | 2017/04/15 |
Last modified on | 2017/06/21 18:59:30 |
Feasibility and efficacy of extended VRd as induction for transplant-eligible NDDM
MMM01 eVRd study
Feasibility and efficacy of extended VRd as induction for transplant-eligible NDDM
MMM01 eVRd study
Japan |
Multiple myeloma
Hematology and clinical oncology |
Malignancy
NO
To examine the safety and efficacy of extended VRd induction therapy in transplant-eligible newly diagnosed multiple myeloma patients.
Safety,Efficacy
Success rate of autologous peripheral blood stem cell harvest
1) CR after autologous transplantation
2) Response rate after induction therapy
3) Flow MRD negative after autologous transplantation
4) Number of harvested stem cells
5) Flow MRD negative in the collected stem cells bags
6) Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
-Induction with Bortezomib/Lenalidomide/Dexamethasone (VRd) for 6 courses.
(Bor 1.3 mg/m2 d1,8,15, Len 25 mg/body d1-21, Dex 20 mg/body d1,2,8,9,15,16,22,23) q28days
-Peripheral blood stem cell harvest with Cyclophosphamide and G-CSF.
-Autologous stem cell transplantation following high-dose Melphalan therapy.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1) Multiple myeloma patients diagnosed with IMWG criteria (2014).
2) Patients with measurable disease.
3) Laboratory data.
Neutrophil > 1000/mm3
Hb > 8.0g/dL
Platelet > 75000/mm3
T-Bil < 1.5x UNL
AST, ALT < 3x UNL
Ccr > 30mL/min
4) Performance Status: 0-2
1) Smoldering or IgM myeloma, solitary plasmacytoma, plasma cell leukemia, POEMS syndrome, WM
2) CNS involvement
3) HIV+, HBs Ag+, or HCV Ab+
4) Severe abnormality in the liver, kidney, cardiac, or pulmonary functions. Severe diabetes, hypertension, or infection.
5) Severe psychotic disorders.
10
1st name | |
Middle name | |
Last name | Satoshi Yoshihara |
Hyogo College of Medicine
Department of Transfusion Medicine and Cellular Therapy
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
0798-45-6348
yoshihar@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Satoshi Yoshihara |
Hyogo College of Medicine
Department of Transfusion Medicine and Cellular Therapy
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
0798-45-6348
yoshihar@hyo-med.ac.jp
Hyogo College of Medicine
Hyogo College of Medicine
Self funding
NO
2017 | Year | 04 | Month | 15 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 03 | Month | 01 | Day |
2017 | Year | 04 | Month | 12 | Day |
2017 | Year | 04 | Month | 11 | Day |
2017 | Year | 06 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030818
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