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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000017713 |
Receipt No. | R000018994 |
Scientific Title | Phase II study of efficiency of peripheral blood stem cell harvest in multiple myeloma patients with low-dose cyclophosphamide plus G-CSF |
Date of disclosure of the study information | 2015/05/28 |
Last modified on | 2015/05/28 |
Basic information | ||
Public title | Phase II study of efficiency of peripheral blood stem cell harvest in multiple myeloma patients with low-dose cyclophosphamide plus G-CSF | |
Acronym | Phase II study of efficiency of peripheral blood stem cell harvest in multiple myeloma patients with low-dose cyclophosphamide plus G-CSF | |
Scientific Title | Phase II study of efficiency of peripheral blood stem cell harvest in multiple myeloma patients with low-dose cyclophosphamide plus G-CSF | |
Scientific Title:Acronym | Phase II study of efficiency of peripheral blood stem cell harvest in multiple myeloma patients with low-dose cyclophosphamide plus G-CSF | |
Region |
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Condition | ||
Condition | multiple myeloma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Evaluation of the efficacy and safety of low-dose cyclophosphamide plus G-GSF regimen for hematopoietic progenitor cell harvest |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Patients collecting >= 2*10^6 CD34+ cells/kg on day 1 (%) |
Key secondary outcomes | Safety
Incidence of adverse events (Grade 3) Effect of this regimen on engraftment The day of first apheresis |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 1)PBSC mobilization using low dose cyclophosphamide and G-CSF
2)autologous peripheral stem cell transplantation after high dose chemotherapy |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)symptomatic multiple myeloma diagnosed by criteria of IMWG
2)The plasma cell in bone marrow counts <= 5% 3) Previous trearments with lenalidomide <= 4 courses 4) Patients who have the latest treatment more than 4 weeks before enrollment 5)age >=20 and <= 70 6)Performance Status(PS) of 0-2 on ECOG scale 7) Patients who have the following laboratory values within 14 days before enrollment .neutrophil count >= 1000/mm3 . Hemoglobin>=8.0g/dl . platelet count >= 100,000/mm3 . ALT <= 2.5 x upper limit of normal AST <= 2.5 x upper limit of normal . serum total bilirubin <= 2.0mg/dl . serum creatinine <= 2.0mg/dl . Normal ECG or asymptomatic minor ECG change . SpO2>=95% 8) Patients who are expected to survive more than 3 months 9) voluntary written informed consent |
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Key exclusion criteria | 1) Patients with plasma cells in CBC
2) Pregnant or nursing women. Patients reuse to contraception during examination period 3) Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment. 4) Patients with serious mental disorders 5) Patients with HBs antigen-positive 6) Patients with HIV antibody-positive 7) Patients with a history of severe allergy to the drugs 8) Patients with serious active infection 9) Patients who are considered as inappropriate to register by attending physicians |
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Target sample size | 22 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Chiba University Hospital | ||||||
Division name | Department of Hematology | ||||||
Zip code | |||||||
Address | 1-8-1 Inohana, Chuo-ku,Chiba city | ||||||
TEL | 043-222-7171 | ||||||
chiaki-nakaseko@faculty.chiba-u.jp |
Public contact | |||||||
Name of contact person |
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Organization | Chiba University Hospital | ||||||
Division name | Department of Transfusion Medicine and Cell Therapy | ||||||
Zip code | |||||||
Address | 1-8-1 Inohana, Chuo-ku,Chiba city | ||||||
TEL | 043-222-7171 | ||||||
Homepage URL | |||||||
shio-sakai@chiba-u.jp |
Sponsor | |
Institute | Department of Hematology
Chiba University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Department of Transfusion Medicine and Cell Therapy
Chiba University Hospital |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018994 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |