UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bortezomib, cyclophosphamide plusd dexamethasone as induction treatment prior to autologous stem cell transplantation in newly diagnosed multiple myeloma
Title of the study (Brief title)	VCD treatment prior to autologous stem cell transplantation in newly diagnosed multiple myeloma
Region	Japan

Condition
Condition	untreated multiple myeloma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of VCD as induction treatment prior to ASCT for patients with newly diagnosed multiple myeloma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	sCR,CR and VGPR rate after 4 cycles of VCD treatment
Key secondary outcomes	1)overall response rate (sCR,CR,VGPR and PR) after 4 cycles of VCD 2)complete response rate (sCR and CR) after 4 cycles of VCD 3)completion rate of 4 cycles of VCD 4)total number of PBSC after PBSCH 5)completion rate of ASCT 6)complete response rate at 100 days after ASCT 7)incidence of adverse events 8)progression free survival duration 9)overall survival duration

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	VCD bortezomib 1.3mg/m2 (iv or sc) on days 1,8,15 and 22 cyclophosphamide 300mg/m2 (po) on days 1,8,15 and 22 dexamethasone 20mg/body (po) on days 1,2,8,9,15,16,22 and 23 VCD treatment is repeated every 5 weeks. PBSCH peripheral stem cell is collected by mobilization with high-dose CPA or G-CSF. for ASCT L-PAM 200mg/m2
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. multiple myeloma defined by IMWG criteria 2.untreated multiple myeloma 3.existence of measurable disease 4. aged >=20 and =<65 5. PS(ECOG) 0-2 6. The following standards are filled 1 )the neutrophil counts >= 1,000/mm3 2) the platelet counts >= 75,000/mm3 3) AST <= 2.5 times of a facilities standard value 4) ALT <= 2.5 times of a facilities standard value 5)T-bil <= 1.5 times of a facilities standard value 6)Cr <= 2.5 mg/dl 7)ischemic change, atrial fibrillation and ventricular arrhythmia to need treatment is neither found in echocardiography. 8) LV Ejection Fraction >= 50% 9)SpO2 >= 94% 10)Neither interstitial pneumonitis, pulmonary fibrosis, emphysema nor plueral effusion is recognized by computed tomography. 7. agree to contraception 8. voluntary written informed consent
Key exclusion criteria	1. severe renal damage: Ccr <30mL/min even after correction of dehydration and hypercalcemia 2.severe cardiac dysfunction: angina pectoris or acute myocardial infarction within 6 months of enrollment, congestive heart failure requiring medical treatment or arrhythmia requiring medical treatment. 3.severe respiratory dysfunction: SpO2 <= 93%, interstitial pneumonitis, chronic obstructive pulmonary disease, active pneumonia 4.infection 4-1HIV positive 4-2HBs antigen positive 4-3HBs antibody positive and/or HBc antibody positive and HBV-DNA positive 4-4HCV antibody positive 5.peripheral neuropathy > grade 2 6.Uncontrolled diabetes mellitus 7.others 7-1active double cancer 7-2pregnancy or breastfeeding 7-3doctor judged adequate to enroll the study
Target sample size	30

Research contact person
Name of lead principal investigator	Rika Sakai
Organization	Kanagawa Cancer Center
Division name	Department of Medical Oncology
Address	2-3-2 Nakao Asahi-ku Yokohama City
TEL	045-520-2222
Email	sakair@kcch.jp

Public contact
Name of contact person	Yukako Hattori
Organization	Kanagawa Cancer Center
Division name	Department of Medical Oncology
Address	2-3-2 Nakao Asahi-ku Yokohama City
TEL	045-520-2222
Homepage URL
Email	hattori-ykh@umin.ac.jp

Sponsor
Institute	Kanagawa Cancer Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
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	横浜市立大学附属病院　（神奈川県）、横浜市立大学附属市民総合医療センター　（神奈川県）、藤沢市民病院　（神奈川県）、横須賀市立市民病院　（神奈川県）、静岡赤十字病院　（神奈川県）、大和市立病院　（神奈川県）、済生会横浜市南部病院（神奈川県）、神奈川県立がんセンター（神奈川県）、横浜市立市民病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 28 Day
Anticipated trial start date	2012 Year 12 Month 20 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 05 Month 31 Day
Date analysis concluded	2019 Year 10 Month 31 Day

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

Management information
Registered date	2013 Year 01 Month 12 Day
Last modified on	2017 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011440