UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009042 |
|---|---|
| Receipt number | R000010563 |
| Scientific Title | Phase II study of bortezomib-melphalan-prednisolone induction therapy followed by lenalidomide-plus-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation. |
| Date of disclosure of the study information | 2012/10/05 |
| Last modified on | 2019/02/24 14:44:14 |
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Basic information
Public title
Phase II study of bortezomib-melphalan-prednisolone induction therapy followed by lenalidomide-plus-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
Acronym
Consolidation AND long-term management by LEnalidomide: CANDLE STUDY / J-MEN 04 STUDY
Scientific Title
Phase II study of bortezomib-melphalan-prednisolone induction therapy followed by lenalidomide-plus-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
Scientific Title:Acronym
Consolidation AND long-term management by LEnalidomide: CANDLE STUDY / J-MEN 04 STUDY
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of bortezomib-melphalan-prednisolone induction therapy followed by lenalidomide-plus-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Median progression-free survival
Key secondary outcomes
1) stringent complete remission rate, 2) complete remission rate, 3) response rate (partial response or better), 4) progression free survival rate at 2 years from the maintenance treatment with lenalidomide, 5) progression free survival rate at 3 years from the maintenance treatment with lenalidomide, 6) progression free survival rate at 2 years from the induction treatment, 7) progression free survival rate at 3 years from the induction treatment, 8) overall survival rate at 2 years from the induction treatment, 9) overall survival rate at 3 years from the induction treatment, 10) frequency of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients received 5 cycles of MPB. MPB included the IV or SQ administration of weekly bortezomib at 1.3 mg/m2 in combination with oral melphalan 6 mg/m2 and prednisone 40 mg/m2 once daily on days 1 - 4 of a 35-day cycle.
After MPB therapy, patients recieved 6 cycles of Ld. Ld treatment consisted of lenalidomide 25 mg daily on days 1-21 plus dexamethasone 40 mg weekly of a 28-day cycle. For the patients of 75 years or older, dexamethasone was reduced to 20 mg/week.
After Ld, patients received maintenance of lenalidomide. Lenalidomide maintenance therapy consisted of lenalidomide 10 mg daily on days 1-21 of a 28-day cycle. If patient achieved CR during BMP or Ld, patient move to maintenance therapy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All the following criteria MUST be met:
1) Age >=20 years old
2) Symptomatic multiple myeloma received NO prior treatment and NO indication for autologous stem cell transplantation
3) Measurable disease: serum IgG, IgA, IgM protein >=0.5 g/dL; IgD >=0.05 g/dL; urinary M-protein excretion 200 mg/24-hour
4) ECOG performance status 0-2 or 3 by bone lesion
5) Preserved organ function:
Serum AST or ALT <3 x ULN
Creatinine clearance >=30 ml/min
Neutrophil >=1000 /mm3
Platelet >=75000 /mm3
Ejection fraction >=50%
PaO2 >=60 mmHg or SpO2 >=93%
6) Able to comply RevMate
7) Disease notified
8) Given voluntary written consent for the this trial
Key exclusion criteria
1) Women in pregnancy or lactation
2) plasma cell leukemia, cardiac amyloidosis, POEMS syndrome
3) Peripheral neuropathy Grade >=2
4) Uncontrolled liver dysfunction, renal dysfunction, heart failure, impaired respiratory function, diabetes, or hyper tension
5) Concurrent diseases of tuberculosis, herpes simplex keratitis, systemic fungal disease, or active infection
6) Postcapsular cataract
7) Recent operation history
8) Myocardial infarction in past 6 months or deep vein thrombosis / pulmonary embolism within 3 months
9) Active and advanced cancer (simultaneous or within 5 years after remission)
10) Positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody
11) Concurrent pneumonitis (interstitial pneumonia), lung fibrosis, or abnormal (high-resolution) chest CT findings in both lung with/without symptom
12) The patient judged inappropriate to participate in this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadao Ishida |
Organization
Sapporo medical university school of medicine
Division name
First department of internal medicine
Zip code
Address
S-1, W-16, CHUO-KU, SAPPORO
TEL
011-611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Miyashita |
Organization
Epidemiological and Clinical Research Information Network (ECRIN)
Division name
Aichi Branch
Zip code
Address
Sanshuya bldg. 2F, 348, kouseicho, Okazaki, Aichi 444-0052, Japan
TEL
0564-66-1220
Homepage URL
miya@ecrin.or.jp
Sponsor or person
Institute
Japan Myeloma Expert Network (J-MEN) of Japan Myeloma Network (JMN)
Institute
Department
Personal name
Funding Source
Organization
Epidemiological and Clinical Research Information Network (ECRIN) (Non-profit Organization)
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 10 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | 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
| 2012 | Year | 10 | Month | 04 | Day |
Last modified on
| 2019 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010563
