UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of new drugs for induction, autologous stem cell transplantation, and consolidation therapy in elderiy patients with newly diagnosed symptomatic multiple myeloma.
Title of the study (Brief title)	FBMTG-EMM13
Region	Japan

Condition
Condition	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 new drugs in elderly patients with newly diagnosed multiple myeloma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate: sCR+CR+VGPR rate 100 days after autologous PBSCT
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	Induction therapy 1-2 cycles: Bortezomib 1.3mg/m2 sc (day1,4,8,11), cyclophosphamide 500mg/m2 po/iv (day1, 8), dexamethasone 40mg/body po/iv (day 1,4,8,11) 3-4 cycles: Bortezomib 1.3mg/m2 sc (day1,8,15,22), cyclophosphamide 300mg/m2 po/iv (day1,8,15,22), dexamethasone 40mg/body po/iv (day1,8,15,22). PBSC harvest: Cyclophosphamide 1.5g/m2 div (day 1,2) High dose chemotherapy and PBSCT: Bortezomib 1.3mg/m2 sc (day-4,-1). L-PAM 70mg/m2 div (day -3,-2). PBSCT (day 0) Consolidation therapy (2 cycles): Bortezomib 1.3mg/m2 sc (day1,8,15,22), thalidomide 100mg/body p.o. (day1-35), and dexamethasone 40mg/boby po/iv (day1,8,15,22).
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	66 years-old <=
Age-upper limit	75 years-old >=
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) ECOG performance status of 0 or 2 (PS 3 possible only for osteolytic lesions.) 4) Age 66-75 years 5) Adequate organ function 6) A life expectancy of at least 3 months 7) Female patients with post menoposal status and the last menstrual period>12 months prior to enrollment in trial, or patients who agree to contraception during the study. 8) Voluntary written informed consent
Key exclusion criteria	1) Nonsecretory MM and plasma cell leukemia. 2) Known human immunodeficiency virus (HIV) infection or active hepatitis A, B or C. 3) Serious concurrent uncontrolled medical disorder. (hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction diabetes, hypertension and infectious diseases) 4) Peripheral neuropathy and neuropathic pain >=Grade 2(CTCAE ver.4.0). 5) History of malignant tumors (except for completely resected in situ carcinoma) during the previous 5 years. 6) Severe uncontrolled psychiatric disorder or illness. 7) Pregnant or lactating female 8) History of hypersensitivity to mannitol or boron. 9) Patients with pneumonia, pulmonary fibrosis or bilateral interstitial abnormalities. 10) Prior steroids treatment (allowed if short term treatment for their general condition or reduction the number of cancer cells) 11) Unwillingness or inability to follow the procedures required in the protocol.
Target sample size	50

Research contact person
Name of lead principal investigator	Toshihiro Miyamoto
Organization	Kyushu University Hospital
Division name	Hematology and Oncology
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5230
Email	fbmtg@intmed1.med.kyushu-u.ac.jp

Public contact
Name of contact person	FBMTG Study Office
Organization	Fukuoka Blood and Marrow Transplantation Group
Division name	EMM13 DC
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5315
Homepage URL
Email	fbmtg@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute	Fukuoka Blood and Marrow Transplantation Group
Institute
Department

Funding Source
Organization	Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization	Profit organization
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	2013 Year 03 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 25 Day
Anticipated trial start date	2013 Year 06 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

Management information
Registered date	2013 Year 03 Month 05 Day
Last modified on	2019 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011878