UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002158 |
|---|---|
| Receipt number | 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 15:43:34 |
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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
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
hhanda@health.gunma-u.ac.jp
Sponsor or person
Institute
Division of clinial oncology and hematology, Jikei University School of
Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002634
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