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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010066
Receipt No. R000011734
Scientific Title Safety and efficiency of modified-VMP schedule for patients with multiple myeloma who are not eligible for high-dose chemotherapy supported with autologous stem-cell trasplantation
Date of disclosure of the study information 2013/02/19
Last modified on 2016/02/18

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Basic information
Public title Safety and efficiency of modified-VMP schedule for patients with multiple myeloma who are not eligible for high-dose chemotherapy supported with autologous stem-cell trasplantation
Acronym Osaka myeloma study group 2nd study (OMSG-2)
Scientific Title Safety and efficiency of modified-VMP schedule for patients with multiple myeloma who are not eligible for high-dose chemotherapy supported with autologous stem-cell trasplantation
Scientific Title:Acronym Osaka myeloma study group 2nd study (OMSG-2)
Region
Japan

Condition
Condition multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In this study, we intend to explore an optimal VMP-treatment-schedule for Japanese patients with multiple myeloma who are not eligible for high-dose chemotherapy supported with autologous stem-cell transplantation. In the VMP-treatment schedule, bortezomib will be used subcutaneously, and the dose of therapeutic agents (bortezomib, melphalan, and predonisolone) will be less intensive than previous VMP schedule conducted in the foreign VISTA study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete remission rate after 5 cycles of consolidation phase of this protocol (Maximum therapeutic results will be judged according to the International Myeloma Working Group Criteria.)
Key secondary outcomes 1. Complete remission rate after 9 cycles of consolidation phase of this protocol (Maximum therapeutic results will be judged according to the International Myeloma Working Group Criteria.)
2. Frequency and degree of adverse events
3. Completion rate of the protocol; Duration of the therapy (including maintenance-period)
4. Time to progression
5. Time to death
6. Cumulative dose and relative-dose-intensity of administered bortezomib

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 1. Induction phase (42 days): Bortezomib 1.3 mg/m2, subcutaneouslly (Days 1, 4, 8, 11, 22, 25, 29 and 32); Melphalan 0.18 mg/kg, orally (Days 1, 2, 3 and 4); Prednisolone 40 mg/m2, orally (Days 1, 2, 3 and 4).

2. Consolidation phase (35 days/cycle): Bortezomib 1.3 mg/m2, subcutaneously (Days 1, 8, 15 and 22); Melphalan 0.18 mg/kg, orally (Days 1, 2, 3 and 4); Prednisolone 40 mg/m2, orally (Days 1, 2, 3 and 4). This treatment will be repeated 6 to 9 cycles until cumulative dose of bortezomib reach to 40 mg/m2.

3. Maintenance phase (28 days/cycle): Bortezomib 1.3mg/m2, Day 1 or Days 1, 15, subcutaneously. (The maintenance phase can be implemented by the judgment of attending physicians.)
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. Patients with multiple myeloma diagnosed from clinical manifestations, laboratory tests, or bone marrow aspiration.
2. Untreated patients having no history of pretreatment before enrollment (Local radiotherapy is not considered as a pretreatment).
3. Patients that attending physicians consider as ineligible for high-dose chemotherapy supported with autologous stem-cell transplantation at the time of initiation of induction therapy; Patients refusing to receive the high-dose chemotherapy.
4. Patients aged 20-year-old or above (At the time of registration)
5. Female patients who are not pregnant or may not become pregnant.
6. Patients accepting contraception by appropriate method during the therapy.
7. Patients without any history of hypersensitivity against bortezomib, mannnitol or boron.
8. Patients with ECOG Performance Status of 0 to 2
9. Patients without a serious and active infectious disease
10. Patients with sufficient major organ function (except the obstacles due to myeloma) for evaluating the safety and efficiency: Meeting all of the following criteria.
a. Neutorophil counts of 750/micro litter or above
b. Platelet counts of 50000/micro litter or above
c. PaO2 of 60mmHg or above; SaO2 of 93% or above
d. No grade 1 peripheral neuropathy with neuropathic pain; no peripheral neuropathy of Grade 2 or more
e. Serum AST/ALT values of 3 times of the upper limit of the standard values in each institute or below
f. Serum total bilirubin values of 2 times of the upper limit of the standard values in each institute or below
g. LVEF of 50% or above
11. Patients who have been fully explained about the purpose and the procedures of the study by the provided Informed Consent Form and have agreed to participate the study from their own will.
Key exclusion criteria 1. Patients with psychiatric disorders or psychological symptoms that are seemed to provide some difficulties for their participation.
2. Patients with a history of pretreatment for myeloma
3. Patients having a serious active infection
4. Patients in whom some signs of interstitial pneumonia present or are suspected in their chest-imaging exams.
5. Patients who have or may have serious pulmonary dysfunction.
6. Patients who have or may have serious cardiac dysfunction.
7. Patients with serum AST/ALT values of greater than 3 times of the upper limit of the standard values in each institute.
8. Patients with serum total bilirubin values of greater than 2 times of the upper limit of the standard values in each institute.
9. Patient with some serious drug-hypersensitivity.
10. Patients who cannot make decisions by themselves
11. Patients who are considered as inappropriate for the registration by attending doctors.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Kosugi
Organization Toyonaka Municipal Hospital
Division name Internal Medicine (Department of Hematology)
Zip code
Address 4-14-1, Shibahara-cho, Toyonaka, Osaka, Japan
TEL +81-6-6843-0101
Email kosugi-s@chp.toyonaka.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Haraga
Organization Tonoyaka Municipal Hospital
Division name the General Affairs Department
Zip code
Address 4-14-1, Shibahara-cho, Toyonaka, Osaka, Japan
TEL +81-6-6843-0101
Homepage URL
Email hsoumu@city.toyonaka.osaka.jp

Sponsor
Institute Toyonaka Municipal Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Hematology and Oncology, Osaka University Hospital
Name of secondary funder(s) None

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 市立豊中病院(大阪府)
大阪大学医学部附属病院(大阪府)
市立伊丹病院(兵庫県)
大阪府立成人病センター(大阪府)
大手前病院(大阪府)
市立吹田市民病院(大阪府)
住友病院(大阪府)
日生病院(大阪府)
箕面市立病院(大阪府)
市立池田病院(大阪府)
NTT西日本大阪病院(大阪府)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially 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 No longer recruiting
Date of protocol fixation
2012 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 24 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 18 Day
Last modified on
2016 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011734

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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