UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011235
Receipt No. R000013103
Scientific Title Phase II study for the evaluation of personalized sVCD-sVTD sequential therapy using VES-13 for newly diagnosed transplant-ineligible multiple myeloma
Date of disclosure of the study information 2013/07/23
Last modified on 2014/06/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study for the evaluation of personalized sVCD-sVTD sequential therapy using VES-13 for newly diagnosed transplant-ineligible multiple myeloma
Acronym Personalized sVCD-sVTD
Scientific Title Phase II study for the evaluation of personalized sVCD-sVTD sequential therapy using VES-13 for newly diagnosed transplant-ineligible multiple myeloma
Scientific Title:Acronym Personalized sVCD-sVTD
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 personalized sequential therapy with sVCD (subcutaneous bortezomib, cyclophosphamide and dexamethasone ), followed by sVTD (subcutaneous bortezomib, thalidomide and dexamethasone) using Vulnerable Elders Survey-13 (VES-13) for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes overall response rate (ORR)
Key secondary outcomes 1)overall survival (OS)
2)progression free survival (PFS)
3)complete response rate
4)treatment continuation rate
5)incidence of adverse events
6)comparison of survival between the two treatment groups
7)the relationship between survival and comorbidity indices (CCI, HCT-CI)
8)the relationship between survival and VES-13
9)comparison of the improvement rate in HR-QOL and VES-13 between the two treatment groups
10)the relationship between known prognostic factors and VES-13
11)the relationship between survival and CD56 expression

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 VES-13 is performed before the start of the study to evaluate frailty.
Patients are allocated into two groups according to VES-13 score.

1) Fit group (VES-13 score 0-2)
2) Frail group (VES-13 score 3-10)


1) Fit group regimen
Standard sVCD
<Cycle 1> (42days/cycle)
Bor 1.3mg/m2 sc
days 1, 4, 8, 11, 22, 25, 29, 32
CY 300mg/m2 po
days 1, 8, 22, 29
Dex 40mg/day po
days 1, 4, 8, 11, 22, 25, 29, 32
<Cycle 2-4> (35days/cycle)
Bor 1.3mg/m2 sc
CY 300mg/m2 po
Dex 40mg/day po
days 1, 8, 15, 22

Standard sVTD
<Cycle5-8> (35days/cycle)
Bor 1.3mg/m2 sc
days 1, 8, 15, 22
Thal 100mg/body po
days 1-35
Dex 40mg/day po
days 1, 8, 15, 22

2) Frail group regimen
Reduced sVCD
<Cycle1-4> (35days/cycle)
Bor 1.3mg/m2 sc
days 1, 8, 15, 22
CY 200mg/m2 po
days 1, 8, 15, 22
Dex 20mg/day po
days 1, 8, 15, 22

Reduced sVTD
<Cycle5-8> (35days/cycle)
Bor 1.3mg/m2 sc
days 1, 8, 15, 22
Thal 50mg/body po
days 1-35
Dex 20mg/day po
days 1, 8, 15, 22
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)untreated patients without a history of pretreatment, excluding local radiotherapy from pretreatment
(3)untreated multiple myeloma patients who diagnosed ineligible for autologous stem cell transplantation.
(4)aged more than 20 years old
(5)performance status:0-2,or 3 due to osteolytic lesions alone
(6)coexisting conditions are eligible as follows:
1)neutrophil count; more than 1,000/mm3
2)platelet count; more than 75,000/mm3
3)serum AST, ALT< 5 times the ULN
4)serum T-Bil< 3 times the ULN
5)serum Cr< 3 times the ULN
6)ejection fraction >= 50%
7)SpO2 >=93%
(7)No dysfunctions due to a symptomatic pre-existing sensory neuropathy (NCI-CTCv4.0 Grade 0 or 1)
(8)Menopausal patients who have had the last menstruation one year or more before and have an intention to prevent conception during the study by contraceptive operation or other appropriate method (a contraceptive or a contraceptive device) or male patients who agree to contraception by contraceptive operation or other appropriate method
(9)Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information.
Key exclusion criteria (1)Patients with a past history of allergy to the drug described in the protocol
(2)Patients who have had a complication of active double cancer within the past 5 years.
(3)HBs antigen positive,HCV antibody positive, HIV antibody positive patients
(4) serious mental disorders such as schizophrenia
(5) Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality on chest CT scan regardless of the presence or absence of symptoms
(6) Patients with severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection
(7)Patients with plasma cell leukemia
(8)Ptients with thrombosis
(9)Women who are or may be pregnant
(10)Other patients who are,in the opinion of the caring investigator, unfit for enrollment in the study
Target sample size 72

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tomonori Nakazato
Organization Yokohama Municipal Citizen's Hospital
Division name Department of Hematology
Zip code
Address 56 Okazawacho, Hodogaya-ku, Yokohama, Kanagawa
TEL 045-331-1961
Email n-tomo@eurus.dti.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomonori Nakazato
Organization Yokohama Municipal Citizen's Hospital
Division name Department of Hematology
Zip code
Address 56 Okazawacho, Hodogaya-ku, Yokohama, Kanagawa
TEL 045-331-1961
Homepage URL
Email n-tomo@eurus.dti.ne.jp

Sponsor
Institute Minato Mirai Hematology Consortium
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 23 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
2013 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 23 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
2013 Year 07 Month 19 Day
Last modified on
2014 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013103

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.