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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002158
Receipt No. R000002634
Scientific Title Clinical study of MP plus zoledronic acid therapy in newly diagnosed multiple myeloma excluding stem cell transplantation patients
Date of disclosure of the study information 2009/07/06
Last modified on 2009/07/02

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Basic information
Public title Clinical study of MP plus zoledronic acid therapy in newly diagnosed multiple myeloma excluding stem cell transplantation patients
Acronym MP plus zoledronic acid therapy in newly diagnosed multiple myeloma
Scientific Title Clinical study of MP plus zoledronic acid therapy in newly diagnosed multiple myeloma excluding stem cell transplantation patients
Scientific Title:Acronym MP plus zoledronic acid therapy in newly diagnosed multiple myeloma
Region
Japan

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

Objectives
Narrative objectives1 Analysis of MP plus zoledronic acid therapy for newly diagnosed nultiple myeloma excluding stem cell transplantation patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Analysis of skeletal-related events on 48 weeks after treatment.
Key secondary outcomes Analysis of skeletal-related events on 104 weeks after treatment.
Response rate of MP plus zoledronic acid on 48 weeks after treatment.
Analysis of bone metabolism marker.
Analysis of bone density (L2-L4) using DXA method.
Frequency of therapy-related toxicity.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Newly diagnosed multiple myeloma using IMWG criteria excluding stem cell transplantaion patient.
Detection of M protein by serum or urine.
Monoclonarity of plasma cell in BM or plasmacytoma.
Organ disorder: renal failure (Cr>2mg/dl), anemia (Hb<10g/dl,or over 2g/dl decreased), bone lesion (lytic lesion or osteoporosis with compression fracture), others (hyperviscosity syndrome, amyloidosis, bacterial infection (over 2 times/ year)
(2)Definition of exclusion of stem cell transplantation.
Imposssible for high dose chemotherapy or disagreement of SCT.
(3) Osteolytic bone disease diagnosed by X-P, CT or MRI.
(4) Over 1 year survival patient
(5) No severe organ damage
AST (under 2 times of limit level)
ALT (under 2 times of limit level)
T-Bil (under 2 times of limit level)
Ccr 30 ml/min
(6) Informed consent by document
Key exclusion criteria (1)Treatment history with bisphosphonate within 3 years.
(2) Double cancer (or more) or cancer past history.
(3)Uncontrollable any complication or infection.
(4) Class III or IV heart disease by NYHA classification.
(5) Under pregnancy, breast-feeding.
(6) Dental infection (within 4 weeks after dental treatment).
(7)Viral hepatitis (HBs antigen or HCV antibody positive)
(8) Patient applied other clinical study.
(9)Others (inappropriate case)
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HIrokazu Murakami
Organization Gunma University
Division name Division of health
Zip code
Address Showa-machi 3-39-15, Mebashi-shi, Gunma
TEL 027-220-8973
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Handa
Organization Gunma University
Division name Division of health
Zip code
Address Showa-machi 3-39-15, Mebashi-shi, Gunma
TEL 027-220-8973
Homepage URL
Email hhanda@health.gunma-u.ac.jp

Sponsor
Institute Division of clinial oncology and hematology, Jikei University School of
Medicine


Institute
Department

Funding Source
Organization Gumma University, and Jikei University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2009 Year 07 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 Preinitiation
Date of protocol fixation
2009 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2013 Year 06 Month 01 Day

Other
Other related information Under investigation

Management information
Registered date
2009 Year 07 Month 02 Day
Last modified on
2009 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002634

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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