UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013773 |
|---|---|
| Receipt number | 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 15:08:29 |
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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
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
HOhno@ntmc.hosp.go.jp
Sponsor or person
Institute
Clinical Hematlogy Study Group of National Hospital Organization (CHSGONHO)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015524
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| Registered date | File name |
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