UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of minimal residual disease,immune cells dynamics and quality of life in bortezomib based induction therapy followed by lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
Title of the study (Brief title)	KHSG MM14
Region	Japan

Condition
Condition	Multiple Myeloma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Analyzing and measuring minimal residual disease (MRD), serum concentration of cytokines and QoL score during lenalidomide monotherapy as maintenace following bortezomib containing induction therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The colleration between the clinical efficacy of lenalidomide for multiple myeloma and the MRD, the serum concentration of cytokines, and QoL socre
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Symptomatic multiple myeloma newly diagnosed by WHO criteria, are ineligible for autologous stem cell transplantation
Key exclusion criteria	patient who is not suitable for taking part in this study from the sight of the physician in charge
Target sample size	40

Research contact person
Name of lead principal investigator	Akifumi Takaori-Kondo
Organization	Kyoto university hospital
Division name	Department of Hematology and Oncology
Address	54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN
TEL	075-751-3150
Email	atakaori@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Toshiyuki Kitano
Organization	Kyoto university hospital
Division name	Department of Hematology and Oncology
Address	54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN
TEL	075-751-3152
Homepage URL
Email	tkitano@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hematology Study Group
Institute
Department

Funding Source
Organization	Graduate school of medicine, Kyoto university, Department of Hematology and Oncology
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	2014 Year 07 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 03 Month 01 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective study The evaluation of MRD, the concentration of serum cytokines and QoL score during Lenalidomide maintenance in newly diagnosed mutiple myeloma patients who are ineligible for autologous transplantation

Management information
Registered date	2014 Year 06 Month 06 Day
Last modified on	2018 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015992