Unique ID issued by UMIN | UMIN000001962 |
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Receipt number | R000002394 |
Scientific Title | Feasibility study of nonmyeloablative allogeneic stem cell transplantation as a consolidation after autologous peripheral blood stem cell transplantation for multiple myeloma with poor prognosis |
Date of disclosure of the study information | 2009/05/13 |
Last modified on | 2011/12/20 15:35:16 |
Feasibility study of nonmyeloablative allogeneic stem cell transplantation as a consolidation after autologous peripheral blood stem cell transplantation for multiple myeloma with poor prognosis
Nonmyeloablative allogeneic stem cell transplantation for multiple myeloma with poor prognosis
Feasibility study of nonmyeloablative allogeneic stem cell transplantation as a consolidation after autologous peripheral blood stem cell transplantation for multiple myeloma with poor prognosis
Nonmyeloablative allogeneic stem cell transplantation for multiple myeloma with poor prognosis
Japan |
Multiple myeloma
Hematology and clinical oncology |
Malignancy
YES
The purpose of this study is to evaluate the feasibility of consolidation with nonmyeloablative allogeneic stem cell transplantation for multiple myeloma with poor prognosis.
Safety,Efficacy
Cumulative incidence of nonrelapse mortality at 6 months
Engraftment rates, regimen-related toxicities, chimerism on peripheral blood, term to hematopoietic recovery, response rates, overall survival rates at 2 years, progression free survival at 2 years, nonrelapse mortality rates at 2 years, incidence of acute GVHD, and incidence of chronic GVHD
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
Nonmyeloablative allogeneic stem cell transplantation as a consolidation
20 | years-old | <= |
65 | years-old | >= |
Male and Female
All of the following are required.
(1)Multiple myeloma patient with evaluable lesion(s)
(2)Age between 20 and 65
(3)PS 0-2
(4)A patient should receive a single high-dose chemotherapy and autologous peripheral blood stem cell transplantation within 60-270 days and achieve partial or complete response.
(5)More than 1x106/kg cryopreserved autologous CD34 positive cells for backup
(6)A patient should have at least one unfavorable factor at initial treatment. Unfavorable factors include ISS stage 3, del13/complex CA/hypodiploid in G-band, t(4;14)/t(14;16)/del17p in FISH.
(7)Suitable donor is available: (a) HLA genotypically identical related donor or (b) HLA-ABC genotypically identical unrelated donor with HLA-DRB1 genotypically mismatched at 0-1 locus.
(8)(a) PaO2>70mmHg or SatO2>90% and (b) serum creatinine <1.5xWNL
(9)HCT-CI 0-2
(10)Written informed consent to participate in the trial.
(1)Positive for HIV antibody, HBs antigen and/or HBe antigen
(2)Pregnant or during breast feeding
(3)Other active cancer
(4)Active psychiatric disease
(5)Active infection
(6)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen.
(7)Cases that physicians judged as inappropriate
22
1st name | |
Middle name | |
Last name | Isamu Sugiura |
Toyohashi Municipal Hospital
Division of Hematology
50 Aza Hachiken Nishi, Aotake–Cho, Toyohashi, Aichi, Japan
0532-33-6111
1st name | |
Middle name | |
Last name | Yoshihiro Inamoto |
Nagoya University Graduate School of Medicine
Department of Hematology and Oncology
65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
052-744-2145
yinamoto@med.nagoya-u.ac.jp
Nagoya Blood and Marrow Transplantation Group
None
Self funding
NO
2009 | Year | 05 | Month | 13 | Day |
Unpublished
Terminated
2009 | Year | 05 | Month | 13 | Day |
2009 | Year | 07 | Month | 01 | Day |
2014 | Year | 06 | Month | 01 | Day |
2009 | Year | 05 | Month | 12 | Day |
2011 | Year | 12 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002394
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