UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012465 |
|---|---|
| Receipt number | R000014553 |
| Scientific Title | Proteasome inhibitor and IMiDs before and after autologous stem cell transplantation for untreated multiple myeloma aiming normalization of para-protein |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2023/12/23 07:00:27 |
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Basic information
Public title
Proteasome inhibitor and IMiDs before and
after autologous stem cell transplantation
for untreated multiple myeloma aiming
normalization of para-protein
Acronym
Proteasome inhibitor and IMiDs before and
after autologous stem cell transplantation
for untreated multiple myeloma aiming
normalization of para-protein
Scientific Title
Proteasome inhibitor and IMiDs before and
after autologous stem cell transplantation
for untreated multiple myeloma aiming
normalization of para-protein
Scientific Title:Acronym
Proteasome inhibitor and IMiDs before and
after autologous stem cell transplantation
for untreated multiple myeloma aiming
normalization of para-protein
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety and efficacy of study protcol therapy (CyBorD induction therapy, LenDex therapy, autologous transplantation, and maintenance therapy with lenalidomide) for previously untreated multiple myeloma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CR rate at day 100 from autologous transplantation
Key secondary outcomes
1) overall response rate
2) treatment completion rate
3) 3-year progression free survival
4) 3-year overall survival
5) safety
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
1) 4 courses of CyBorD therapy(cyclophosphamide, bortezomib, and dexamethasone)
2) If not reached VGPR by CyBorD therapy, add lenalidomide and dexamethasone therapy, maximum 4 courses
3) Periheral blood stem cell harvest mobilised by filgrastim alone or cyclophosphamide and filgrastim
4) High dose therapy of melphalan
followed by autologous periheral blood stem cell transplantation
5) Maintenance therapy with lenalidomide for 2 years or till PD
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with symptomatic multiple myeloma
2) Patients who have never received therapy for myeloma, excluding local radiation therapy
3) Patients with measurable disease
(Serum M-protein >= 1g/dL, Urinary M-protein >=200mg/day, or tumor derived-FLC(iFLC)>100mg/L)
4) Performance Status being 0-2. Patients with Performance Status of 3 due to bone lesion are permitted
5) Patients who have the following laboratory values within 14 days before enrollment
1. SpO2 >= 94%
2. neutrophil count >= 1000/mm3
3. platelet count >= 75000/mm3
4. Patients who do not require hemodialysis
5. serum total bilirubin <= 1.5 x upper limit of normal
6. ALT <= 2.5 x upper limit of normal
7. AST <= 2.5 x upper limit of normal
7) Patients who agreed to contraception by an appropriate method
8) Written informed concent has been obtained
Key exclusion criteria
1) Patients with a history of allergy to the drugs used in the protocol therapy
2) Patients who can not be expected to survive more than 3 months
3) Patients who suffered another carcinoma within 5 years
4) Patients with HBs antigen-positive, or HCV antibody-positive, or HIV antibody-positive
5) Patients who have peripheral neuropathy or peripheral neuropathic pain of grade 2 or more.
6) Patients with serious active infection or patients who are suspected to have serious active infection infections
7) Patients with serious mental disorders
8) Patients with serious pulmonary dysfunction
9) Patients with interstitial pneumonia or pulmonary fibrosis
10) Patients with serious heart dysfunction
11) Patients with poorly controlled diabetes
12) Patients receiving hemodialysis
13) Patient who are or may be pregnant or are nursing
14) Patients who are determined to be inappropriate for study by physician
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Kanda |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Hematology
Zip code
330-0834
Address
1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL
048-647-2111
ycanda-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Yamamoto |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
Homepage URL
gyamamot-tky@umin.ac.jp
Sponsor or person
Institute
Division of Hematology, Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Celgene Corporation
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
Jichi Medical University Central Clinical Research Ethics Committee
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
Tel
0285-58-7637
jmu-crb2020@jichi.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs031180335
Org. issuing International ID_1
National Institute of Public Health
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 01 | 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
64
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 | 12 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014553
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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