UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010166 |
|---|---|
| Receipt number | 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 10:51:01 |
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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
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
fbmtg@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Fukuoka Blood and Marrow Transplantation Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011878
