UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010401 |
|---|---|
| Receipt number | R000011434 |
| Scientific Title | Phase II study of induction therapy with subcutaneous bortezomib, oral melphalan and predonisone for newly diagnosed multiple myeloma patients ineligible for stem cell transplantation |
| Date of disclosure of the study information | 2013/04/03 |
| Last modified on | 2019/04/09 09:37:01 |
* 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 of induction therapy with subcutaneous bortezomib, oral melphalan and predonisone for newly diagnosed multiple myeloma patients ineligible for stem cell transplantation
Acronym
Phase II study of MP plus subcutaneous bortezomib for newly diagnosed multiple myeloma patients ineligible for stem cell transplantation
Scientific Title
Phase II study of induction therapy with subcutaneous bortezomib, oral melphalan and predonisone for newly diagnosed multiple myeloma patients ineligible for stem cell transplantation
Scientific Title:Acronym
Phase II study of MP plus subcutaneous bortezomib for newly diagnosed multiple myeloma patients ineligible for stem cell transplantation
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 induction therapy with subcutaneous bortezomib, oral melphalan and predonisone for newly diagnosed multiple myeloma patients ineligible for stem cell transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
complete response rate
Key secondary outcomes
overall response rate, progression free survival, overall survival, incidence rate of adverse events, rate of complete treatment
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
MPB(subcutaneous bortezomib, oral melphalan and predonisone) treatment
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All the following criteria MUST be met:
1)Symptomatic multiple myeloma in IMWG diagnostic criteria
2)Newly diagnosed multiple myeloma patients ineligible autologous stem cell transplantation
3)Multiple myeloma received NO prior treatment
4)Measurable disease: serum IgG >=1.0 g/dL; IgA, IgD protein >=0.5 g/dL; urinary M-protein excretion 0.2 g/ 24 hour
5)Age >=20 year old and <=80 year old
6)PS 0-2 or 3 by osteolytic lesion
7)All the following criteria MUST be met:
Neutrophil >=1000 /mm3
Platelet >=75000 /mm3
hemoglobin >=8.0 g/dl
Serum AST or ALT <=2.5 x ULN
Serum total bilirubin <=2.0mg/dl
Serum creatinine <=2.5mg/dl
Compensated serum Ca <=12.5 mg/dl
Serum Na >130 mEq/l
ECG: normal or asymptomatic and required no treatment
Ejection fraction >=50%
SpO2 >=95%
8)Prognosis more than 3 months
9)Given voluntary written consent for this study
Key exclusion criteria
1)Women in pregnancy or lactation; women who can not or intend to use appropriate contraceptive methods
2)Active and advanced cancer
3)steroid administration equivalent to 10mg prednisolone for other disease
4)psychiatric disease or psychological symptom
5)Positive for HBs antigen or able to detect HBV DNA
6)Positive for HCV antibody
7)Positive for HIV antibody
8)poorly controlled diabetes mellitus
9)poorly controlled hypertension
10)Cardiac amyloidosis
11)Angina; acute myocardial infarction last 6 months; heart failure or arrythmia that needs treatment
12)Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema or pleural effusion that allows aspiration
13)Peripheral neuropathy Grade >=2; painful peripheral neuropathy
14)Severe drug allergy
15)The patient judged inappropriate to participate in this study
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Ando |
Organization
Tokai University School of Medicine
Division name
Department of Hematology/ Oncology
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
andok@keyaki.cc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ogiya |
Organization
Tokai University School of Medicine
Division name
Department of Hematology/ Oncology
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
giya_pen_1213.0@triton.ocn.ne.jp
Sponsor or person
Institute
Kanagawa Clinical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University Hospital Clinical Trials Center
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.jp
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 | 04 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | 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
| 2013 | Year | 04 | Month | 02 | Day |
Last modified on
| 2019 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011434
