UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006604 |
|---|---|
| Receipt number | R000007812 |
| Scientific Title | Phase I/II study to evaluate the efficacy and safety of the combination treatment of melpharan, dexamethasone and bortezomib for relapsed or refractory systemic AL amyloidosis. |
| Date of disclosure of the study information | 2011/10/24 |
| Last modified on | 2015/04/29 15:01:05 |
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Basic information
Public title
Phase I/II study to evaluate the efficacy and safety of the combination treatment of melpharan, dexamethasone and bortezomib for relapsed or refractory systemic AL amyloidosis.
Acronym
BMD treatment for relapsed or refractory systemic AL amyloidosis.
Scientific Title
Phase I/II study to evaluate the efficacy and safety of the combination treatment of melpharan, dexamethasone and bortezomib for relapsed or refractory systemic AL amyloidosis.
Scientific Title:Acronym
BMD treatment for relapsed or refractory systemic AL amyloidosis.
Region
| Japan |
Condition
Condition
To evaluate the efficacy and safety of the combination treatment melpharan, dexamethasone and bortezomib (BMD treatment) for relapsed or refractory systemic AL amyloidosis.
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Nephrology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the combination treatment melpharan, dexamethasone and bortezomib (BMD treatment) for relapsed or refractory systemic AL amyloidosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Hematological response rate post 6 months treatment
Key secondary outcomes
Maximum tolerant dose, Organ response rate post 6 months treatment, Plasma free light chain level change from baseline, Average progression free survival, Average overall survival, Adverse event rate
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
Patients receive oral melphalan 8 mg/m2 on days 1-4, bortezomib SC (IV) on days 1, 4, 8 and 11, and dexamethasone orally on days 1-2, 4-5 8-9 11 and 12. Treatment repeats every 4 weeks (28 days) for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
*The preventive medication on last medication day after the 28th is recommended in principle from acyclovir 200 or 400 mg/the bortezomib medication opening day of a day.
Moreover, when the symptoms of herpes are shown, the acyclovir or the rose cyclo building of a therapeutic amount is promptly prescribed for the patient.
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)Confirmed diagnosis of AL amyloidosis
2)20 to 65 years old
3)Previously treated (within 3 courses of chemotherapy)
4)Transplant ineligible
5)Meeting all of the following
*Serum creatinine =< 2 mg/dL
*Serum ALT and AST =< 2.5 times upper limit of normal
*Serum AlP =< 3 times upper limit of normal
*Serum direct bilirubin =<2 mg/dL
*WBC >= 3000/micro L (neutrophi count>=/micro L)
*Platelet count >= 75000/micro L
*HB >=8g/dL
6)No chronic disease (respiratory, neurological disease, or severe
diabetes mellitus) that may disturb therapy.
7)No carriers of hepatitis virus, HTLVI virus or HIV virus
Key exclusion criteria
1)Untreated patients
2)History of botezomib exposure
3)Poor-risk patients (Skinner et al.Ann Intern Med140:85,2004)
i)Decompensated heart failure (NYHA>=3)
ii)Ejection fraction < 0.40
iii)Persistent pleural effusion
iv)Systolic blood pressure < 90 mmHg
v)Oxygen saturation < 95%,room air
vi)Performance Status >= 3
4)Neurological disorders (peripheral neuropathy, orthostatic hypotension, or paralytic ileus) excluding carpal tunnel syndrome
5)Gastrointestinal symptoms
6)NT-proBNP >= 332 pg/mL (BNP >=50 pg/mL)
7)A case with pulmonary complication (interstitial pneumonia, lung fibrosis, lung amyloidosis, etc.): Check abnormalities by evaluation by CT, utilize KL-6, SP-D, and SP-A laboratory data auxiliary, and judge synthetically.
8)Subject was pregnant or potential
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Ando |
Organization
Kumamoto University
Division name
Faculty of life science, Department of Diagnostic Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto city, Kumamoto prefecture
TEL
096-373-5893
amyloid@fc.kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chihiro Shimazaki |
Organization
Japan Community Health care Organization Kyoyo kuramaguchi Medical Center
Division name
Department of Hematology
Zip code
Address
27 koyamashimofusa-cho,kita-ku,Kyoto
TEL
075-441-6101
Homepage URL
simazaki@shaho-kyothsp.jp
Sponsor or person
Institute
Japan Community Health care Organization Kyoto kuramaguchi Medical Center, Department of Hematology
Institute
Department
Personal name
Funding Source
Organization
Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Janssen Pharmaceutical K.K (Investigational drug provider)
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
札幌医科大学附属病院
独立行政法人国立病院機構西群馬病院
日本赤十字社医療センター
愛知医科大学病院
独立行政法人地域医療機能推進機構京都鞍馬口医療センター
金沢大学附属病院
徳島大学病院
九州大学病院
熊本大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 04 | Month | 04 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 24 | Day |
Last modified on
| 2015 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007812
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| Registered date | File name |
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| Registered date | File name |
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