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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010166
Receipt No. R000011878
Scientific Title Efficacy and safety of new drugs for induction, autologous stem cell transplantation, and consolidation therapy in elderiy patients with newly diagnosed symptomatic multiple myeloma.
Date of disclosure of the study information 2013/03/06
Last modified on 2019/03/09

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Basic information
Public title Efficacy and safety of new drugs for induction, autologous stem cell transplantation, and consolidation therapy in elderiy patients with newly diagnosed symptomatic multiple myeloma.
Acronym FBMTG-EMM13
Scientific Title Efficacy and safety of new drugs for induction, autologous stem cell transplantation, and consolidation therapy in elderiy patients with newly diagnosed symptomatic multiple myeloma.
Scientific Title:Acronym 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
1st name
Middle name
Last name Toshihiro Miyamoto
Organization Kyushu University Hospital
Division name Hematology and Oncology
Zip code
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
1st name
Middle name
Last name FBMTG Study Office
Organization Fukuoka Blood and Marrow Transplantation Group
Division name EMM13 DC
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 01 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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