UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010853 |
|---|---|
| Receipt number | R000012531 |
| Scientific Title | A prospective study to validate the efficacy on the induction, consolidation, and maintenance therapy for the elderly multiple myeloma patients. |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2018/10/10 23:36:17 |
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Basic information
Public title
A prospective study to validate the efficacy on the induction, consolidation, and maintenance therapy for the elderly multiple myeloma patients.
Acronym
Teikyo elderly MM study
Scientific Title
A prospective study to validate the efficacy on the induction, consolidation, and maintenance therapy for the elderly multiple myeloma patients.
Scientific Title:Acronym
Teikyo elderly MM study
Region
| Japan |
Condition
Condition
Multiple myeloma patients over the age of 70.
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We validate that the induction, consolidation, and maintenance therapy with adjusting dose, schedule, and route of administration of four drug-combinations (Bortezomib, Lenalidomide, Thalidomide, Dexamethasone) improve efficacy and safely for multiple myeloma patients aged over 70.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Efficacy at the end of two sequential induction therapies
Efficacy includes over-all response rate, VGPR and above CR ratio by IMWG uniform response criteria.
Key secondary outcomes
Safety profile of induction, consolidation, and maintenance therapy, rate of continuation in maintenance therapy, improvement of efficacy during consolidation and maintenance therapy, progression free survival, prognosis of 75 years of age or older
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
1st induction therapy
Bortezomib 1.0 mg/m2 on days 1, 8, 15, and 22 injected subcutaneously (sc)
Dexamethasone 8 mg/body on days 1, 8, 15, and 22 per os (po) or intravenous drip-injection (div)
1st cycle for 35days
2nd induction therapy
Bortezomib 1.0 mg/m2 on days 1, 8, 15, and 22 sc
Dexamethasone 8 mg/body on days 1, 8, 15, and 22 po or div
Lenalidomide 10 mg/body on days 1, 8, 15, and 22 po
One cycle for 5 weeks' interval, 3 cycles
Consolidation and maintenance
Bortezomib 1.0 mg/m2 on days 1, and 15 sc
Thalidomide 50 mg/body every other day po
One cycle for 5 weeks' interval, 6 cycles
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are eligible who are diagnosed as a symptomatic (active) MM referred to International Myeloma Working Group (IMWG) criteria, and
1. There are no pre-treated MM therapies without steroid administration or radiation therapy due to hyper calcemia or relieving symptoms.
2. Age at 70 years old or older
3. Karnofsky performance status > 50%(PS 0-2). If patients with PS 3 or 4 or KS >20% patients induced of fructure only, can enroll in this study.
4. Laboratory data
1) Absolute neutrophil count > 1,000 /mm3
2) Platelet count > 50,000 /mm3
3) Hb > 7.0 g/dL
4) AST, ALT < 5 times the ULN
5) T-Bil < 3 times the ULN
6) Cr < 2.5 mg/dL
5. No dysfunctions due to a symptomatic pre-existing sensory neuropathy NCICTC grade 3-4
6. In the case of women, after menopause, surgical contraception or patients who are not willing to use birth control during the study.
7. can comply to register (Lenalidomide, Thalidomide drug management program) to RevMate, TERMS
Key exclusion criteria
Patients who are not eligible for this study are:
1. may be pregnant or are pregnant.
2. suffered from an active cancer within the last five years.
3. HBs antigen positive, HCV-antibody positive, HIV-antibody positive
4. severe psychometric dysfunction
5. with interstitial pneumonitis
6. with a severe active infection
7. with a severe pulmonary dysfunction; PaO2/FiO2 ratio <200
8. with a severe cardiac dysfunction; percent fractional shortening <15%
9. judged unsuitable by the doctor
10. cannot take an oral administration.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shirasaki Ryosuke |
Organization
University of Teikyo School of Medicine
Division name
Internal medicine, department of Hematology/Oncology
Zip code
Address
2-11-1 Kaga Itabashi-ku Tokyo
TEL
0339641211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shirasaki Ryosuke |
Organization
University of Teikyo School of Medicine
Division name
Internal medicine, department of Hematology/Oncology
Zip code
Address
TEL
Homepage URL
ryosuke@med.teikyo-u.ac.jp
Sponsor or person
Institute
University of Teikyo School of Medicine, Internal medicine, department of Hematology/Oncology
Institute
Department
Personal name
Funding Source
Organization
University of Teikyo School of Medicine, Internal medicine, department of Hematology/Oncology
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
帝京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 01 | Day |
Last modified on
| 2018 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012531
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