UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007918 |
|---|---|
| Receipt number | R000009324 |
| Scientific Title | Safety and efficacy of lenalidomide, dexamethasone, and clarithromycin therapy in Japanese patients with multiple myeloma, a phase I/II study |
| Date of disclosure of the study information | 2012/05/11 |
| Last modified on | 2012/05/09 18:46:30 |
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Basic information
Public title
Safety and efficacy of lenalidomide, dexamethasone, and clarithromycin therapy in Japanese patients with multiple myeloma, a phase I/II study
Acronym
lenalidomide, dexamethasone, and clarithromycin therapy in Japanese patients with multiple myeloma
Scientific Title
Safety and efficacy of lenalidomide, dexamethasone, and clarithromycin therapy in Japanese patients with multiple myeloma, a phase I/II study
Scientific Title:Acronym
lenalidomide, dexamethasone, and clarithromycin therapy in Japanese 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
To investigate MTD, safety and efficacy of lenalidomide, dexamethasone, and clarithromycin therapy in Japanese patients with multiple myeloma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of adverse events
Key secondary outcomes
Maximum tolerated dose,
Best response rate,
Duration of response,
Progression-free survival
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lenalidomide 25mg/day (days 1-21), Dexamethasone 20mg/day (days 1, 8, 15, 21), Clarithromycin 200mg twice a day (days 1-28) in a 28-day cycle
Interventions/Control_2
Lenalidomide 25mg/day (days 1-21), Dexamethasone 20mg/day (days 1, 8, 15, 21), Clarithromycin 400mg twice a day (days 1-28) in a 28-day cycle
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
;Japanese patient with primary refractory or relapsed/refractory multiple myeloma
;Agree in writing to voluntarily participate in the study by have been obtained
;ECOG performance status: 0-2
;Measurable serum or urine M-protein
;Agree to register and follow RevMate
Key exclusion criteria
Cardiac infarction within 6 months
Deep vein thrombosis or pulmonary embolism within 3 years
Tuberculosis,herpes simplex keratitis, mycosis, or other active infections at baseline
Uncontrollable diabetes mellitus, hypertension, peptic ulcer, or glaucoma
Posterior capsule opacification
Patients with mental illness
Those who are considered as inappropriate to register by attending physicians
Pregnant or breast feeding females
Grade 2 or more peripheral neuropathy
Any of following laboratory abnormalities
Absolute neutrophil count < 1000
Platelet count< 75000
Creatinine clearance < 60 mL/ min
Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal
Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for > 3 years
Radiotherapy within 14 days
Wound by recent organ surgery
HIV-positive
Known hypersensitivity to dexamethasone
Known hypersensitivity to macrolides
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kazuo tsubaki |
Organization
Nara Hospital Kinki University School Of Medicine
Division name
Department of Hematology
Zip code
Address
1248-1 Otsuda, Nara, 630-0293 JAPAN
TEL
0743-77-0880
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | hitoshi hanamoto |
Organization
Nara Hospital Kinki University School Of Medicine
Division name
Department of Hematology
Zip code
Address
1248-1 Otsuda, Nara, 630-0293 JAPAN
TEL
0743-77-0880
Homepage URL
hanamoto@nara.med.kindai.ac.jp
Sponsor or person
Institute
Nara Hospital Kinki University School Of Medicine
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 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | 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
| 2012 | Year | 05 | Month | 09 | Day |
Last modified on
| 2012 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009324
