UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of bortezomib-melphalan-prednisolone induction therapy followed by lenalidomide-plus-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
Title of the study (Brief title)	Consolidation AND long-term management by LEnalidomide: CANDLE STUDY / J-MEN 04 STUDY
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-melphalan-prednisolone induction therapy followed by lenalidomide-plus-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma 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	Median progression-free survival
Key secondary outcomes	1) stringent complete remission rate, 2) complete remission rate, 3) response rate (partial response or better), 4) progression free survival rate at 2 years from the maintenance treatment with lenalidomide, 5) progression free survival rate at 3 years from the maintenance treatment with lenalidomide, 6) progression free survival rate at 2 years from the induction treatment, 7) progression free survival rate at 3 years from the induction treatment, 8) overall survival rate at 2 years from the induction treatment, 9) overall survival rate at 3 years from the induction treatment, 10) frequency of adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients received 5 cycles of MPB. MPB included the IV or SQ administration of weekly bortezomib at 1.3 mg/m2 in combination with oral melphalan 6 mg/m2 and prednisone 40 mg/m2 once daily on days 1 - 4 of a 35-day cycle. After MPB therapy, patients recieved 6 cycles of Ld. Ld treatment consisted of lenalidomide 25 mg daily on days 1-21 plus dexamethasone 40 mg weekly of a 28-day cycle. For the patients of 75 years or older, dexamethasone was reduced to 20 mg/week. After Ld, patients received maintenance of lenalidomide. Lenalidomide maintenance therapy consisted of lenalidomide 10 mg daily on days 1-21 of a 28-day cycle. If patient achieved CR during BMP or Ld, patient move to maintenance therapy.
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	All the following criteria MUST be met: 1) Age >=20 years old 2) Symptomatic multiple myeloma received NO prior treatment and NO indication for autologous stem cell transplantation 3) Measurable disease: serum IgG, IgA, IgM protein >=0.5 g/dL; IgD >=0.05 g/dL; urinary M-protein excretion 200 mg/24-hour 4) ECOG performance status 0-2 or 3 by bone lesion 5) Preserved organ function: Serum AST or ALT <3 x ULN Creatinine clearance >=30 ml/min Neutrophil >=1000 /mm3 Platelet >=75000 /mm3 Ejection fraction >=50% PaO2 >=60 mmHg or SpO2 >=93% 6) Able to comply RevMate 7) Disease notified 8) Given voluntary written consent for the this trial
Key exclusion criteria	1) Women in pregnancy or lactation 2) plasma cell leukemia, cardiac amyloidosis, POEMS syndrome 3) Peripheral neuropathy Grade >=2 4) Uncontrolled liver dysfunction, renal dysfunction, heart failure, impaired respiratory function, diabetes, or hyper tension 5) Concurrent diseases of tuberculosis, herpes simplex keratitis, systemic fungal disease, or active infection 6) Postcapsular cataract 7) Recent operation history 8) Myocardial infarction in past 6 months or deep vein thrombosis / pulmonary embolism within 3 months 9) Active and advanced cancer (simultaneous or within 5 years after remission) 10) Positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody 11) Concurrent pneumonitis (interstitial pneumonia), lung fibrosis, or abnormal (high-resolution) chest CT findings in both lung with/without symptom 12) The patient judged inappropriate to participate in this study
Target sample size	80

Research contact person
Name of lead principal investigator	Tadao Ishida
Organization	Sapporo medical university school of medicine
Division name	First department of internal medicine
Address	S-1, W-16, CHUO-KU, SAPPORO
TEL	011-611-2111
Email

Public contact
Name of contact person	Yumi Miyashita
Organization	Epidemiological and Clinical Research Information Network (ECRIN)
Division name	Aichi Branch
Address	Sanshuya bldg. 2F, 348, kouseicho, Okazaki, Aichi 444-0052, Japan
TEL	0564-66-1220
Homepage URL
Email	miya@ecrin.or.jp

Sponsor
Institute	Japan Myeloma Expert Network (J-MEN) of Japan Myeloma Network (JMN)
Institute
Department

Funding Source
Organization	Epidemiological and Clinical Research Information Network (ECRIN) (Non-profit Organization)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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 10 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 08 Month 21 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
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	2012 Year 10 Month 04 Day
Last modified on	2019 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010563