UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008576 |
|---|---|
| Receipt number | R000010074 |
| Scientific Title | To investigate the efficacy and safety of lenalidomide and dexamethasone for elderly or frail patients with relapsed/refractory multiple myeloma |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2015/02/08 14:17:26 |
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Basic information
Public title
To investigate the efficacy and safety of lenalidomide and dexamethasone for elderly or frail patients with relapsed/refractory multiple myeloma
Acronym
Iwate Study MM2012
Scientific Title
To investigate the efficacy and safety of lenalidomide and dexamethasone for elderly or frail patients with relapsed/refractory multiple myeloma
Scientific Title:Acronym
Iwate Study MM2012
Region
| Japan |
Condition
Condition
Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of dose adjusted therapy with lenalidomide and dexamethasone according to the European Myeloma Network Recommendation for elderly or frail patients with relapsed/refractory multiple myeloma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to progression
Key secondary outcomes
1. Overall response rate
2. Incidents of adverse events
3. Discontinuation rate of treatment
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
No risk factors
Lenalidomide 25mg po (day 1-21, every 28 days)
Dexamethasone 40mg po/div (day 1,8,15,22, every 28 days) until PD or unacceptable toxicity
At least one risk factor (either age 75 or older, frailty, disability, or comorbidity)
Lenalidomide 15mg po (day 1-21, every 28 days)
Dexamethasone 20mg po/div (day 1,8,15,22, every 28 days) until PD or unacceptable toxicity
severe non-hematologic adverse events during treatment
Lenalidomide 10mg po (day 1-21, every 28 days)
Dexamethasone 10mg po/div (day 1,8,15,22, every 28 days) until PD or unacceptable toxicity
In patients with renal dysfunction
CLcr 30-60mL/min: 10mg (day 1-21, every 28 days)
(If tolerable after 2 cycles, dose is able to increase to 15mg).
CLcr <30mL/min (hemodyalysis is unnecessary): 15mg every a day (day 1-21, every 28 days).
CLcr <30mL/min (hemodyalysis is necessary):
5mg/day (day 1-21, every 28 days)
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. Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG).
2. Measurable M protein in serum or urine.
3. Age from 20 years old.
4. Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.)
5. Main organ function is maintained.
6. Those who are evaluated to be able to survive more than 3 months.
7. For female patients, postmenopause (patients older than one year from the last menstrual period), or the proper way of surgical contraception (birth control pill, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study.
8. In patients receiving the notice, fully briefed for the consent document and other document given explanation about the contents by the study physician or study investigator, agreed writing to voluntarily participate in the study have been obtained.
Key exclusion criteria
1. History of hypersensitivity to lenalidomide.
2. Non-secretory MM and plasma cell leukemia.
3. Patients HIV-positive, HBsAg-positive, HCV-positive.
4. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled hypertension, and uncontrolled infection.
5. Patients with psychiatric disorders.
6. Pregnant women, pre-menopausal women and lactating women.
7. Patients with a history of active malignancy.
8. Those who are considered as inappropriate register by attending physicians.
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoji Ishida |
Organization
Iwate Medical University Hospital
Division name
Hematology/Oncology
Zip code
Address
19-1 Uchimaru, Morioka City, Iwate 020-8505, Japan
TEL
019-651-5111
yishida@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeki Ito |
Organization
Iwate Medical University Hospital
Division name
Hematology/Oncology
Zip code
Address
19-1 Uchimaru, Morioka City, Iwate 020-8505, Japan
TEL
019-651-5111
Homepage URL
shigei@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Myeloma treatment Study Group
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2012 | Year | 08 | 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
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
| 2012 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 30 | Day |
Last modified on
| 2015 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010074
| 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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| Registered date | File name |
