UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011568 |
|---|---|
| Receipt number | R000012396 |
| Scientific Title | Lenalidomide/dexamethasone Salvage Therapy with stepwise Evatuation for Practical Dose Finding Study |
| Date of disclosure of the study information | 2013/08/24 |
| Last modified on | 2013/08/23 19:05:32 |
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Basic information
Public title
Lenalidomide/dexamethasone Salvage Therapy with stepwise Evatuation for Practical Dose Finding Study
Acronym
L-STEP
Scientific Title
Lenalidomide/dexamethasone Salvage Therapy with stepwise Evatuation for Practical Dose Finding Study
Scientific Title:Acronym
L-STEP
Region
| Japan |
Condition
Condition
refractory/resistant multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of lenalidomide+dexamethason therapy for refractory/resistant multiple myeloma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
overall response after 6 cycles
Key secondary outcomes
1. lenalidomide concentration in serum
2. the incidence of DLT
3. the incidence of adverse events
4. the persistent ratio after 6 cycles
5. TTP
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration of lenalidomide (15 mg/day, days 1-21, po), and dexamethasone (20 mg/day day 1, 8, 15, 22, po) in each cycle.(28 days).
If the patients achieve PR and more state, total 6 cycles will be given. The dose of lenalidomide will increase up to 25 mg/day in the patients who achieve less than PR state. The gradual dose reduction of lenalidomide in the patients with adverse events will be permitted.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) symptomatic multiple myeloma diagnosed by the criteria of international Myeloma Working Group(IMWG)
(2) patients with aged more than 15 years old who diagnosed ineligible for autologous stem cell transplantation at induction therapy
(3) refractory/resistant multiple myeloma patients who were untreated with lenalidomide, and has a history of more than one regimen
(4) performance status:0-3
*neutrophil count; more than 1,000/mm3
*platelet count; more than 50,000/mm3
*total billbin in serum; 3 times less than normal upper limit
*AST, ALT in serum; 5 times less than normal upper limit
(6) be expected to be alive more than 6 months
(7) creatinin clearance>=60ml/min
(8) without a history of deep vein thrombosis and pulmonary thrombosis
(9) patients who are observed RevMate
(10) Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information.
Key exclusion criteria
(1)Patients with a past history of receiving lenalidomide
(2)Patients with a past history of allergy to lenalidomide and thalidomide
(3) Patients with non-secretary myeloma, solitary myeloma, plasma cell leukemia, or POEMS syndrome
(4) HBs antigen,or HCV antibody positive patients
(5) HTLV-1 antibody,or HCV antibody positive patients
(6) Patients with a history of malignancies
(7) Womeb with pregnancy or during lactation
(6) be expected to be alive more than 6 months
(7) creatinine clearance>=60ml/min
(8) without a history of deep vein thrombosis and pulmonary thrombosis
(9) patients who are observed RevMate
(10) Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information.
(8) Patients with uncontrolled dysfunction of liver, kidney, heart, diabetes, hypertension, and infection
(9) Patients with serious abalienation
(10) Patients with deep vein thrombosis or pulmonary thrombosis
(11) Other patients who are in the opinion of the caring investigator, unfit for enrollment in the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Kizaki |
Organization
Saitama Medical Center,Saitama Medical University
Division name
Department of Hematology
Zip code
Address
1981,Kamoda,Kawagoe-shi,Saitama,
TEL
049-228-3471
tokuhira@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Watanabe |
Organization
Saitama Medical Center,Saitama Medical University
Division name
Department of Hematology
Zip code
Address
1981,Kamoda,Kawagoe-shi,Saitama,
TEL
049-228-3471
Homepage URL
reikow@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center,Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center,Saitama Medical University
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
| 2013 | Year | 08 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 23 | Day |
Last modified on
| 2013 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012396
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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