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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000178 |
Receipt No. | R000000248 |
Scientific Title | Phase II Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401) |
Date of disclosure of the study information | 2005/09/12 |
Last modified on | 2016/11/02 |
Basic information | ||
Public title | Phase II Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401) | |
Acronym | Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401) | |
Scientific Title | Phase II Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401) | |
Scientific Title:Acronym | Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401) | |
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 | To test efficacy and safety of a series of treatment from induction chemotherapy to single peripheral autologous transplantation for patients with newly diagnosed multiple myeloma. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Response rate after 90 days from the transplantation |
Key secondary outcomes |
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 | Therapy is composed of the following three steps of therapy.
1. induction chemotherapy(3 courses of C-VAD regimen) 2. peripheral stem cell collection after high dose cyclophosphamide 3. autologous peripheral stem cell transplantation after high dose melphalan |
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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. Multiple Myeloma(SWOG criteria).
2. Durie&Salomon Stage II or III. 3. No previous treatments 4. age >=16 and <= 65 5. PS 0-2(ECOG) 6. No clinically significant abnormalities in liver, heart and pulmonary functions 7. Written informed consent |
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Key exclusion criteria | 1. Severe renal dysfunction
2. Severe cardiovascular dysfunction 3. Active infections 4. Active opportunistic infections 5. Active double cancers 6. Subjects who, in the opinion of the investigator, are not likely to participate in the study for any reason |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Toyohashi Municipal Hospital | ||||||
Division name | Division of Hematology | ||||||
Zip code | |||||||
Address | 50 Hakken-Nishi, Aotake-cho, Toyohashi #441-8570 | ||||||
TEL | 0532-33-6111 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Toyohashi Municipal Hospital | ||||||
Division name | Division of Hematology | ||||||
Zip code | |||||||
Address | 50 Hakken-Nishi, Aotake-cho, Toyohashi #441-8570 | ||||||
TEL | 0532-33-6111 | ||||||
Homepage URL | http://www.c-shot.or.jp/ | ||||||
isugiura-sgr@umin.ac.jp |
Sponsor | |
Institute | Center for Supporting Hematology-Oncology Trials (C-SHOT) |
Institute | |
Department |
Funding Source | |
Organization | Nagoya BMT group |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | JAPAN |
Other related organizations | |
Co-sponsor | Nagoya Muliple Myeloma Collaborated Group |
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 | http://www.c-shot.or.jp/ |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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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=R000000248 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |