Unique ID issued by UMIN | UMIN000021864 |
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Receipt number | R000025208 |
Scientific Title | Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant |
Date of disclosure of the study information | 2016/05/15 |
Last modified on | 2017/04/12 09:14:04 |
Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant
Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant
Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant
Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant
Japan |
Multiple Myeloma
Hematology and clinical oncology |
Malignancy
NO
This clinical trial studies peripheral blood hemapoietic stem cell mobilization with the combination of bortezomib, low dose cyclophosphamide and G-CSF in multiple myeloma patients
Efficacy
Successful mobilization (Single collection:>4x106/kg CD34 positive cell) rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Patients receive bortezomib (1.3mg/2 day4,7), cyclophosphamide (1g/m2 day1) and G-CSF (days 4-) and begin apheresis on day 8. Patients undergo apheresis for up to 2 days.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
(1)Diagnosis with multiple myeloma and eligible for 1st autologous transplantation
(2)ECOG performance status 0-2
(3)WBC >2.5x109/L, Neutrophil 1.2x109/L, Platelet count >100x109/L
(4)AST, ALT, T-Bil less than two times the upper limit of normal
(5)Serum Cr =< 2mg/dl
(6)Left ventricular ejection fraction => 50%
(7)SpO2 =>95%
(8)Voluntary written informed consent form before performance of any study-related procedure
(1)Patient has hypersensitivity to bortezomib, cyclophosphamide, and G-CSF.
(2)Patient has Grade =>2 peripheral neuropathy
(3)Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, cardiac amyloidosis
(4)Known interstitial Pneumonitis
(5)Uncontrolled intercurrent infection
(6)Known HBs antigen positive, HCV antibody positive
(7)Known HTLV-I antibody positive, HIV antibody positive
(8)Female patients who are pregnant and/or breastfeeding.
(9)Active gastrointestinal bleeding
(10)Serious psychiatric illness
(11)A co-morbid condition which, in the view of the investigators, renders the patient at high risk for this study
8
1st name | |
Middle name | |
Last name | Masahide Yamamoto |
Tokyo Medical and Dental University
Department of Hematology
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
03-5803-5211
hide.hema@tmd.ac.jp
1st name | |
Middle name | |
Last name | Masahide Yamamoto |
Tokyo Medical and Dental University
Department of Hematology
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
03-5803-5211
hide.hema@tmd.ac.jp
Ochanomizu Hematology Study Group
NPO Ibaraki blood, tumor, palliative care study committee
Other
NO
2016 | Year | 05 | Month | 15 | Day |
Unpublished
No longer recruiting
2016 | Year | 04 | Month | 11 | Day |
2016 | Year | 05 | Month | 30 | Day |
2016 | Year | 04 | Month | 11 | Day |
2017 | Year | 04 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025208
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