UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026324 |
|---|---|
| Receipt number | R000030235 |
| Scientific Title | A phase 2 study of bortezomib, lenalidomide and dexamethasone (VRD) following auto-PBSCT for untreated multiple myeloma. |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2020/07/28 15:15:41 |
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Basic information
Public title
A phase 2 study of bortezomib, lenalidomide and dexamethasone (VRD) following auto-PBSCT for untreated multiple myeloma.
Acronym
OCHA-VRD
Scientific Title
A phase 2 study of bortezomib, lenalidomide and dexamethasone (VRD) following auto-PBSCT for untreated multiple myeloma.
Scientific Title:Acronym
OCHA-VRD
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of VRD (Bortezomib, lenalidomide, dexamethasone) therapy following mobilization using bortezomib, low-dose cyclophosphamide, G-CSF and high-dose melphalan plus autologous peripheral blood stem cell transplantation(auto-PBSCT) for untreated multiple myeloma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CR/nCR rate for VRD therapy
Key secondary outcomes
Overall survival (OS);
Progression free survival (PFS);
Overall response rate for VRD therapy;
Overall response rate at 90 days after ASCT;
Best response through the trial;
Adverse event;
CD34+ cell count after aphereses;
Rate of reaching CD34+ cell count >= 2*10^6/kg;
Therapy related quality of life.
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. VRD (Bortezomib 1.3mg/m2 s.c.;d1,4,8,11, lenalidomide 25mg/day p.o.;d1-14, dexamethasone 40mg/day;d1,4,8,11) therapy as induction therapy.
2. Mobilization using bortezomib,low-dose cyclophosphamide and G-CSF(cyclophosphamide 1g/m2 div;d1, bortezomib 1.3mg/m2 s.c.;d4,7, G-CSF;day4-)
3. High-dose melphalan plus auto-PBSCT(L-PAM 200mg/m2 div;d -2)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patient in symptomatic multiple myeloma or symptomatic nonsecretary myeloma according to IMWG criteria(2011).
2.Patient who has measurable disease.
3.Age >= 20 and <= 65 at time of registration.
4.ECOG-Performance Status(PS)is 0-2.
5.No interstitial pulmonary disorder is detected by X-ray or CT.
6.Patent who meets the following criteria;
a) Liver function:T-Bil <= 1.5*ULN, AST or ALT <= 2.5*ULN;
b) Bone marrow function ANC >= 1000/uL, Platelet >= 7.5*10^4/uL;
c) Heart function: EF >= 55%;
d) Pulmonary function: SpO2 >= 93%;
e) Renal function: Ccr >= 30ml/min(Cockroft-Gault).
7.Untreated multiple myeloma.
8.Patient who can agree the registration for RevMate and keep its administrative procedure.
9.Patient who provided written consents for this study.
Key exclusion criteria
1.Patient who has hypersensitivity to the study drugs.
2.Patient who has Grade >= 2 peripheral neuropathy (NCI CTCAE ver.4).
3.Patient who has sufficient heart disorders.
4.Uncontrolled active infection.
5.HBs antigen positive and/or HCV positive.
6.Active advanced-stage cancer.
7.Female patient who is pregnant and/or breastfeeding.
8.Active gastrointestinal bleeding.
9.Past history of renal transplantation.
10.Past history of pulmonary embolism, myocardial infarction and cerebral infarction.
11.Past history of deep vein thrombosis, administration of anticoagulants and/or antiplatelet drugs.
12.Uncontrolled diabetes mellitus.
13.Serious psychiatric illness
14.Patient who is judged to be medically unfit by his/her physician.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Ikuyo |
| Middle name | O |
| Last name | Tsutsumi |
Organization
National Hospital Organization Mito Medical Center
Division name
Department of Hematology
Zip code
311-3193
Address
280 Sakuranosato, Ibaraki-machi, Higashi-Ibaraki-gun, Ibaraki, JAPAN
TEL
029-240-7711
ikuyo.ota@gmail.com
Public contact
Name of contact person
| 1st name | Ikuyo |
| Middle name | O |
| Last name | Tsutsumi |
Organization
National Hospital Organization Mito Medical Center
Division name
Department of Hematology
Zip code
311-3193
Address
280 Sakuranosato, Ibaraki-machi, Higashi-Ibaraki-gun, Ibaraki, JAPAN
TEL
029-240-7711
Homepage URL
ikuyo.ota@gmail.com
Sponsor or person
Institute
Ochanomizu Hematology Study Group
Institute
Department
Personal name
Funding Source
Organization
NPO Ibaraki blood, tumor, palliative care study committee
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
National Hospital Organization Mito Medical Center IRB
Address
280, Sakuranosato, Ibarakimachi, Higashiibarakigun, Ibaraki, Japan
Tel
029-240-7711
mito.kenkyu.g@mn.hosp.go.jp
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
| 2017 | Year | 03 | 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
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 27 | Day |
Last modified on
| 2020 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030235
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