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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013773
Receipt No. R000015524
Scientific Title Phase II Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 75 Years With Alternating Bortezomib/dexamethasone (Bd) With Lenalidomide/dexamethasone (Ld).
Date of disclosure of the study information 2014/06/01
Last modified on 2017/04/23

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Basic information
Public title Phase II Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 75 Years With Alternating Bortezomib/dexamethasone (Bd) With Lenalidomide/dexamethasone (Ld).
Acronym Induction therapy for Myeloma, AlteRnating Bortezomib and LEnalidomide: MARBLE study/2013-NHO(Hematology)-02
Scientific Title Phase II Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 75 Years With Alternating Bortezomib/dexamethasone (Bd) With Lenalidomide/dexamethasone (Ld).
Scientific Title:Acronym Induction therapy for Myeloma, AlteRnating Bortezomib and LEnalidomide: MARBLE study/2013-NHO(Hematology)-02
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 safety and efficacy of Bortezomib-dexamethasone (Bd) alternating with Lenalidomide-dexamethasone (Ld) as induction therapy for newly diagnosed multiple myeloma patients older than 75 years (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 Overall response rate (ORR)
Key secondary outcomes Safety (toxicity and tolerability)
Continuation rate of treatment
Complete response rate
Very good partial response rate
Progression-free survival rate (PFS)
Overall survival rate (OS)
Time to response (TTR)

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-dexamethasone (Bd) alternating with Lenalidomide-dexamethasone (Ld)
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Age of patients older than 75 years.
2. Symptomatic multiple myeloma newly diagnosed by WHO criteria, are ineligible for autologous stem cell transplantation.
3. Patients with Measurable disease; M-protein level is more than 0.5g/dL for the IgG, IgA, or IgM type myeloma, M-protein level is more than 0.05g/dL for the IgD type, or urinary M-protein excretion is more than 200 mg/24-hour.
4. Performance status (ECOG) <= 2, or 3 due to osteolytic lesions alone.
5. Have pre-treatment clinical laboratoly values meeting the following criteria:
* AST, ALT < 3.0xULN
* Creatinine clearance >= 30 mL/min
* Absolute neutrophil count (ANC) >= 1.0x10^9/L
* Platelet count >= 50x10^9/L
* Ejection fraction >= 50%
* PaO2 >= 60mmHg or SpO2 >= 93%
6. Agreement to RevMate registration was obtained, patients can comply with the contents.
7. In patients on notice, and received an explanation enough for the contents of this study, patient consent was obtained in writing to participate in the study by the free will.
Key exclusion criteria 1. Plasma cell leukemia, cardiac amyloidosis, POEMS syndrome.
2. Patients has >= Grade 2 peripheral neuropathy.
3. Uncontrolled liver dysfunction, renal dysfunction, heart failure, impaired respiratory function, diabetes, or hyper tension.
4. Concurrent diseases of tuberculosis, herpes simplex keratitis, systemic fungal disease, or active infection.
5. Recent operation history.
6. Myocardial infarction within 6 months of enrolment or deep vein thrombosis/ pulmonary embolism within 3 years.
7. Patient has active and advanced double cancer (simultaneous or within 5 years post remission).
8. Positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody.
9. Patients with pneumonitis (interstitial pneumonia) or pulmonary fibrosis in clinical, or abnormal (high-resolution) chest CT findings bilateral lung regardless of the presence or absence of symptoms.
10. Patient has hypersensitivity to boron or mannitol.
11. Patient has psychiatric diseases or psychological symptoms.
12. Patient judged inappropriate to participate in this study.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Yokoyama
Organization National Hospital Organization Tokyo Medical Center
Division name Division of Hematology, Department of Internal Medicine
Zip code
Address 2-5-1, Higasigaoka, Meguro-ku, Tokyo 152-8902, Japan
TEL 03-3411-0111
Email ayokoyama@ntmc.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromi Ohno
Organization National Hospital Organization Tokyo Medical Center
Division name Documents support clerk
Zip code
Address 2-5-1, Higasigaoka, Meguro-ku, Tokyo 152-8902, Japan
TEL 03-3411-0111
Homepage URL
Email HOhno@ntmc.hosp.go.jp

Sponsor
Institute Clinical Hematlogy Study Group of National Hospital Organization (CHSGONHO)
Institute
Department

Funding Source
Organization National Hospital 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
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 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 Completed
Date of protocol fixation
2014 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 20 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
2014 Year 04 Month 21 Day
Last modified on
2017 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015524

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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