UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001213 |
|---|---|
| Receipt number | R000001478 |
| Scientific Title | Phase II study of weekly irinotecan (CPT-11) for relapsed and/or refractory multiple myeloma |
| Date of disclosure of the study information | 2008/07/01 |
| Last modified on | 2013/01/04 21:20:52 |
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Basic information
Public title
Phase II study of weekly irinotecan (CPT-11) for relapsed and/or refractory multiple myeloma
Acronym
Phase II study of weekly CPT-11 for relapsed and/or refractory multiple myeloma
Scientific Title
Phase II study of weekly irinotecan (CPT-11) for relapsed and/or refractory multiple myeloma
Scientific Title:Acronym
Phase II study of weekly CPT-11 for relapsed and/or refractory multiple myeloma
Region
| Japan |
Condition
Condition
relapsed and/or refractory multiple myeloma after treatment with bortezomib or thalidomide (lenalidomide) in addition to the prior treatment with melphalan
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this trial is to investigate the efficacy and safety of irinotecan(CPT-11) for the patients with relapsed and/or refractory multiple myeloma, who has received bortezomib or thalidomide(lenalidomide) in addition to the prior treatment with melphalan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression free survival, overall survival, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Three times administration of weekly irinotecan(CPT-11) followed by 2-week rest is repeated every four weeks for up to 8 courses.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) symptomatic multiple myeloma based on the criteria proposed by International Myeloma Working Group (IMWG)
2) relapsed and/or refractory cases after treatment with bortezomib or thalidomide (lenalidomide) in addition to the prior treatment with melphalan
3) having measurable lesions such as (1) serum paraprotein of more than 1.0g/dl IgG or 0.5g/dl IgA/IgD, (2) Bence Jones protein of more than 0.2g/day, and (3) plasmacytoma with more than 2cm in long diameter
4) performance status: 0-2, or 3 due to osteolytic lesions alone
5) at least 22 days have passed after the prior therapy
6) WBC: more than 3000/mm3 or neutrophil: more than 1500/mm3, AST/ALT: no more than 2.5 x normal upper limit, creatinine: no more than 1.5mg/dl, PaO2 (room air): more than 70torr, normal ECG and ejection fraction: more than 50%
7) written informed consent by the patient
Key exclusion criteria
1) prior treatment history with irinotecan
2) serious allergic history
3) severe infection
4) diarrheae: more than 5 times a day
5) paralytic or mechanical ileus
6) massive pleural effusion or ascites
7) interstitial pneumonia, pulmonary fibrosis
8) uncontrollable diabetes mellitus
9) patients treated with warfarin
10) pregnant woman
11) symptomatic intracranial metastasis or invasion
12) psychosis
13) synchronous or metachronous malignancy
14) HBs-Ag positive or HIV-Ab positive
15) patients treated with atazanavir
16) blood infusion or G-CSF administration within 7 days
17) cardiac or gastrointestinal amyloidosis
18) inadequate to be enrolled in the protocol study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Iida |
Organization
Nagoya City University Hospital
Division name
Division of Hematology and Collagen Diseases
Zip code
Address
1, Aza-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8602, Japan
TEL
0528515511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Kusumoto |
Organization
Nagoya City University Hospital
Division name
Division of Hematology and Collagen Diseases
Zip code
Address
1, Aza-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8602, Japan
TEL
0528515511
Homepage URL
kusshan@rb3.so-net.ne.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2008 | Year | 07 | Month | 01 | Day |
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
Protocol revision to extend to enroll patients until the end of March in 2012 was approved by the Institutional Review Board. However, this clinical trial was terminated on March 31, 2012 due to the poor accrual. It was because a lot of novel agents for multiple myeloma became available during the period of this trial. So far, only four patients were enrolled.
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
Terminated
Date of protocol fixation
| 2008 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 26 | Day |
Last modified on
| 2013 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001478
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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