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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010853
Receipt No. 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

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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
Email

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
Email ryosuke@med.teikyo-u.ac.jp

Sponsor
Institute University of Teikyo School of Medicine, Internal medicine, department of Hematology/Oncology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012531

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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