UMIN-CTR Clinical Trial

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
Last 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
Email	andok@keyaki.cc.u-tokai.ac.jp

Public contact
1st 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
Email	giya_pen_1213.0@triton.ocn.ne.jp

Sponsor
Institute	Kanagawa Clinical Oncology Group
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011434