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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013169
Receipt No. R000015356
Scientific Title Phase I/II study of bortezomib plus Lenalidomide and dexamethasone (Once weekly VRd-21) for relapsed and/or refractory multiple myeloma (Once weekly VRd-21, I/II VRD for MM)
Date of disclosure of the study information 2014/02/15
Last modified on 2016/02/22

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Basic information
Public title Phase I/II study of bortezomib plus Lenalidomide and dexamethasone (Once weekly VRd-21) for relapsed and/or refractory multiple myeloma
(Once weekly VRd-21, I/II VRD for MM)

Acronym Phase I/II study of once weekly VRd-21 for relapsed and/or refractory multiple myeloma
(Once weekly VRd-21, I/II VRD for MM)

Scientific Title Phase I/II study of bortezomib plus Lenalidomide and dexamethasone (Once weekly VRd-21) for relapsed and/or refractory multiple myeloma
(Once weekly VRd-21, I/II VRD for MM)

Scientific Title:Acronym Phase I/II study of once weekly VRd-21 for relapsed and/or refractory multiple myeloma
(Once weekly VRd-21, I/II VRD for MM)

Region
Japan

Condition
Condition Proteasome inhibitor and immunomodulatory drug pre-treated relapsed and/or refractory multiple myeloma after two or more prior lines of chemotherapy
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this trial is to evaluate the safety and efficacy of bortezomib plus Lenalidomide and dexamethasone (Once weekly VRd-21) for relapsed or refractory multiple myeloma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes maximum tolerated dose
objective response rate, PR above
Key secondary outcomes overall survival
progression-free survival
time to progression
adverse event
treatment efficacy according to the translocation of chromosome myeloma related

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 bortezomib (subcutaneous injection, days 1,8) plus lenalidomode (days 1-14) dexamethasone (20mg/day, days
1,2,8,9) were administered for eight 21-cycles.

Phase1
level -1
bortzomib 1.0 mg/m2, lenalidomide 10 mg/body, dexamethasone 20 mg/body
level 1
bortzomib 1.3 mg/m2, lenalidomide 10 mg/body, dexamethasone 20 mg/body
level 2
bortzomib 1.3 mg/m2, lenalidomide 15mg/body, dexamethasone 20 mg/body

Phase2
At the Phase 2 study, adminstration was decided based on the result of Phase 1 study
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 1) diagnosed as having symptomatic multiple myeloma before initial treatment
2) relapsed and or refractory cases after at least two prior chemotherapy including both proteasome inhibitor and one immunomodulatory drug
3) no limit of age
4) either menopausal women aged at 50 or older, women after hysterectomy, or women after bilateral ovariectomy. Females of childbearing potential must adhere to the guideline of the Revmate program.
5) men who agreed to use contraception according to the guideline of the Revmate program.
6) performance status 0-2,or 3 due to osteolytic lesions alone
7) having measurable paraprotein defined as serum monoclonal immunoglobulin concentration of at least 1.0gdL of IgG, or at least 0.5g/dL of absolute serum concentration of IgA IgD, or urinary excretion of at least 0.2g of paraprotein per 24 hours in spite of the type of myeloma
8) at least 14 days have passed after the prior therapy of multiple myloma, including chemotherapy, radiotherapy, and surgery. Transient administration of steroid is permitted
9) absolute neutrophil count no less than 750/mm3, platelet count no less than 50,000/mm3,
, AST/ALT no more than 100IU/L, total bilirubin 1.8 mg/dL or below, creatinine clearrance 50 mL/min or above at phase 1 study (no limitation at the phase 2 study except for need of dialysis),
SpO2 (room air) at least 94%, ECG neither ischemic change nor arrhythmia reqiuring medical intervention, cardiac ejection fraction at least 50%
10) no history of hypersensitivity to bortezomib, lenalidomide, and dexamethasone
11) peripheral neuropathy(PN) within grade 2 without pain. Management of PN is permitted.
12) written informed consent by the patient
Key exclusion criteria 1) synchronous or metachronous malignancy
2) active infection
3) severe constipation or illeus
4) interstitial pneoumonia, pulmonary fibrosis
5) uncontrolled diabetes
6) inability to intake antithrombotic medication
7) pregnant or nursing women mellitus
8) uncontrollable hypertension
9) psychological disturbance
10) active double cancer
11) HBs-Ag positive or HCV-Ab positive or HIV-Ab positive
12) grade 3 or higher peripheral neuropathy, or grade 1 or higher neuralgia
13) glaucoma
14) primary plasma cell leukemia
15) no adminstration of blood transfusion or G-CSF within 7days befor the treatment
16) no evidence of cardiac or intestinal amyloidosis
17) allergic history to borate or mannitol
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Ri
Organization Nagoya City University Hospital
Division name Division of Hematology & Collagen Diseases
Zip code
Address 1, Aza-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
TEL 052-853-8217
Email rrmasaki@ybb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruhito Totani
Organization Nagoya City University Hospital
Division name Division of Hematology & Collagen Diseases
Zip code
Address 1, Aza-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
TEL 052-853-8217
Homepage URL
Email shimuroini0421@yahoo.co.jp

Sponsor
Institute Nagoya City University Hospital
Institute
Department

Funding Source
Organization Nagoya City University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 名古屋市立大学病院
名古屋記念病院
豊川市民病院
厚生連 海南病院

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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
2014 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 14 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
2015 Year 08 Month 31 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2015 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 15 Day
Last modified on
2016 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015356

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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