UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study evaluating safety and efficacy of induction therapy with small-dose bortezomib, lenalidomide and dexamethasone combination for previously untreated symptomatic multiple myeloma
Title of the study (Brief title)	HCHSG-MM-214
Region	Japan

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

Objectives
Narrative objectives1	Evaluating safety and efficacy of induction therapy with small-dose bortezomib, lenalidomide and dexamethasone combination for previously untreated symptomatic multiple myeloma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate Incidence of adverse events
Key secondary outcomes

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	<BD therapy; 1 course> Dexamethasone 40 mg/day (day 1, 8, 15, 22) and subcutaneous injection of bortezomib 1.3 mg/m2/day (day 1, 15), one course in 28-day cycle. <small BLD (sBLD) therapy; 12 courses> Lenalidomide 10 mg day (day 1-21), dexamethasone 40 mg/day (day 1, 8, 15, 22) and subcutaneous injection of bortezomib 1.3 mg/m2/day (day 1, 15), 12 courses in 28-day cycle.
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	Previously untreated symptomatic multiple myeloma who are not candidates for stem cell transplantation. Measureable M protein in serum or urine. Good performance status (0-2). Patients with bad performance status due to osteolytic lesions can be included. Age more than 20 years old. Main Organ function is maintained. Those who are evaluated to be able to survive more than 3 months. 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	Non-secretory multiple myeloma or plasma cell leukemia. HIV-, HBs-, or HCV-positive patients. Severe or uncontrolled hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction, diabetes, hypertension, infection, or psychiatric disorder. Patients with active and progressive malignancy. Women who are pregnant or in lactation. Those who are considered as inappropriate to register by attending physicians.
Target sample size	30

Research contact person
Name of lead principal investigator	Tsutomu Sato
Organization	Sapporo Medical University Hospital
Division name	Fourth Department of Internal Medicine
Address	S-1, W-16, Chuo-ku, Sapporo
TEL	011-611-2111
Email	tsutomus@sapmed.ac.jp

Public contact
Name of contact person	Tsutomu Sato
Organization	Sapporo Medical University Hospital
Division name	Fourth Department of Internal Medicine
Address	S-1, W-16, Chuo-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	tsutomus@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University Hospital
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	2015 Year 01 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 19 Day
Anticipated trial start date	2015 Year 01 Month 19 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

Management information
Registered date	2015 Year 01 Month 19 Day
Last modified on	2018 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017324