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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012100
Receipt No. 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

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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&#39;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
Email 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
Email hide.hema@tmd.ac.jp

Sponsor
Institute Ochanomizu blood study committee
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014140

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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