UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012100 |
|---|---|
| Receipt number | R000014140 |
| Scientific Title | A feasible study of lenalidomide for multiple myeloma in maintenance use at post autologous peripheral blood stem cell transplantation |
| Date of disclosure of the study information | 2013/10/24 |
| Last modified on | 2016/04/22 09:33:11 |
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Basic information
Public title
A feasible study of lenalidomide for multiple myeloma in maintenance use at post autologous peripheral blood stem cell transplantation
Acronym
Lenalidomide maintenance therapy in patients with multiple myeloma
Scientific Title
A feasible study of lenalidomide for multiple myeloma in maintenance use at post autologous peripheral blood stem cell transplantation
Scientific Title:Acronym
Lenalidomide maintenance therapy in patients with multiple myeloma
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to estimate feasible initial dose level of lenalidomide in patients with multiple myeloma after autologous peripheral blood stem cell transplantation, and to evaluate the efficacy and safety of lenalidomide for all qualified cases.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Estimation of "feasible initial dose level"
Key secondary outcomes
(1) DLT frecquencies
(2) Adverse event frequencies
(3) A continuous administration period
(4) A complete response rate after lenalidomide administration (3 months)
(5) Time to progression
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
The dose increase and decrease judgment in the first and second cohort
1. Three patients are enrolled in the first cohort (level 2). If continuous administration for 12 weeks, three patients will be enrolled in the dose escalation to level 3 in second cohort.
2. If in two of three cases, three patients will be enrolled in the second cohort at level 2 without being carried out.
3. If 12 weeks continuous administration successful execution is one of three cases, three patients will be enrolled with the dose reduction to level 1 in the second cohort.
4. If continuous administration successful execution is none of three cases, case registration will be cancelled and will hold effect safety assessment Committee and review validity of the dose setting.
The dose modifications after the third cohort
After the third cohort, the dose will be calculated using CRM procedure with a statistical analysis person in charge based on continuous administration successful execution data after an administration observed in the first and second cohort sequentially for twelve weeks.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Aged 15<= and 70>=
(2) Patients with multiple myeloma after autologous peripheral blood stem cell transplantation
(3) WBC >3000/mm 3,Neutrophil>1,500/mm 3, hemoglobuin>10g/dl, Platelet>100,000/mm 3
(4) VGRP or CR after autologous peripheral stem cell transplantation
(5) More than 6 months after autologous peripheral blood stem cell transplantation
(6) PS (ECOG) 0-2
(7) Main organ function is maintenanced
(8) Creatinin clearance >= 60ml/min
(9) Patients without deep vein thrombosis or pulmonary embolism
(10) Signed the informed consent, have the will and ability to follow the protocol
Key exclusion criteria
(1) Known hypersensitivity to lenalidomide
(2) Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI CTCAE version 2
(3) Uncontroled infectious diseases
(4) HBs antigen, HCV antibody positive
(5) HTLV-I antibody, HCV antibody positive
(6) Pregnancy or breastfeeding
(7) Active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Sakamaki |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Director
Zip code
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo, Japan
TEL
03-3823-2101
sakamaki-h@cick.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahide Yamamoto |
Organization
Tokyo Medical and Dental University
Division name
Department of Hematology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5211
Homepage URL
hide.hema@tmd.ac.jp
Sponsor or person
Institute
Ochanomizu blood study committee
Institute
Department
Personal name
Funding Source
Organization
NPO Ibaraki blood, tumor, palliative care study committee
Organization
Division
Category of Funding Organization
Non profit foundation
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
がん・感染症センター都立駒込病院(東京)、日立製作所日立総合病院（茨城県）、東京医科歯科大学（東京都）、水戸医療センター（茨城県）、茨城県立中央病院（茨城県）、埼玉医科大学（埼玉県）、埼玉医科大学国際医療センター（埼玉県）、武蔵野赤十字病院（東京都）、横須賀共済病院（神奈川県）、横浜市立みなと赤十字病院（神奈川県）、青梅市立総合病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 22 | Day |
Last modified on
| 2016 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014140
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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