UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To investigate the efficacy and safety of bortezomib as maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation
Title of the study (Brief title)	Kanshinetsu MMG-002
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 bortezomib-based induction therapy followed by bortezomib maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression-free survival
Key secondary outcomes	Incidents of adverse events during maintenance therapy

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	Bortezomib-based induction therapy followed by bortezomib maintenance therapy (1.3mg/m2) in every 2 weeks for one year.
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. Measureable M protein in serum or urine. 3. Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.) 4. Age more than 20 years old. 5. Main Organ function is maintained 6. Those who are evaluated to be able to survive more than 3 months. 7. In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained.
Key exclusion criteria	1. Non-secretory MM and plasmacell leukemia. 2. Patients HIV-HBs-and HCV-positive 3. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. 4. Patients with a history of active malignancy during the past 5 years. 5. Patients with psychiatric disorders such as schizophrenia etc. 6. History of hypersensitivity to mannitol or boron. 7. Patient was suspected pneumonia(Interstitial pneumonia). Consult a respiratory specialist if necessary 8. Those who are considered as inappropriate to register by attending physicians.
Target sample size	35

Research contact person
Name of lead principal investigator	Hirokazu Murakami
Organization	Gunma Graduate School of Health Scineces
Division name	Department of Laboratory Sciences,
Address	3-39-22 Showa-machi, Maebashi-shi, Gunma
TEL
Email

Public contact
Name of contact person	Atsushi Isoda
Organization	NHO National Nishigunma Hospital
Division name	Department of Internal Medicine
Address	2854 Kanai, Shibukawa-shi, Gunma
TEL	0279-23-3030
Homepage URL
Email

Sponsor
Institute	Kanshinetsu Multiple Myeloma Group
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)

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	2012 Year 05 Month 02 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 03 Month 05 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 02 Day
Last modified on	2016 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009276