UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022213 |
|---|---|
| Receipt number | R000025587 |
| Scientific Title | The association of Cytokine /chemokine profiles with the clinical outcome and safety in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone |
| Date of disclosure of the study information | 2016/05/11 |
| Last modified on | 2019/05/13 12:26:28 |
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Basic information
Public title
The association of Cytokine /chemokine profiles with the clinical outcome and safety in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone
Acronym
Cytokine /chemokine profiles in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone
Scientific Title
The association of Cytokine /chemokine profiles with the clinical outcome and safety in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone
Scientific Title:Acronym
Cytokine /chemokine profiles in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association of Cytokine /chemokine profiles with the clinical outcome and safety in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The serum cytokine level,chemokine level and the counts of peripheral lymphocytes.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients will receive Lenalidomide(25mg on days 1-21) and dexamethazone(40mg on days1,8,15,22 in patinets aged between 20 to 74 and 20mg on days 1,8,15,22 in patinets aged 75 years or more) on 28-day cycle. The dose of lenalidomide is adjusted based on the guideline.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Multiple myeloma diagnosed aged 20 years or more
2.Relapsed or refractory multiple myeloma without lenalidemide and medical history over the past 1 or 2 regimen
3.ECOG of Performance Status between 0 and 2
4.M protein in serum or urine is assessable.
5.Preserved function of major organs
6.Predicting survival time is more than 3 months.
7.Menopausal female or male and female who are enable to prevent conception by the adequate methods, including the surgical conception.
8.Informed consent in writing
Key exclusion criteria
1.Previous treatment with lenalidomide
2.Hypersensitivity to lenalidomide and/or dexamethasone
3.non-secretory myeloma, solitary plasmacytoma, plasma cell leukemia, of POEMS syndrome
4.Positivity of HBs antigen or, HCV or HIV antibody
5.Uncontrollable liver dysfunction, renal dysfunction, cardiac dysfunction, respiratory dysfunction, diabetes mellitus, hypertension and infection
6.Double cancer requiring treatments 7.Psychoneurotic disorder, depression state or history 8.Patients with pregnancy, patients who may be pregnant, or patients during lactation
9.Pulomonary fibrosis, interstitial pneumonitis or interstitial shadow on chest CT, even if no symptom 10.Ineligible patient by physicians decision
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Ono |
Organization
Hamamatsu University School of Medicine
Division name
Department of Internal Medicine III (Division of hematology)
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
+81-53-435-2267
takaono@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Nagata |
Organization
Hamamatsu University School of Medicine
Division name
Department of Internal Medicine III (Division of hematology)
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
+81-53-435-2267
Homepage URL
yasu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Celgene
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Center for Clinical research, Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
Tel
+81-53-435-2676
yamoto@hama-med.ac.jp
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
| 2016 | Year | 05 | Month | 11 | 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
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 05 | Month | 05 | Day |
Last modified on
| 2019 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025587
