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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006604
Receipt No. 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

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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
Email 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
Email simazaki@shaho-kyothsp.jp

Sponsor
Institute Japan Community Health care Organization Kyoto kuramaguchi Medical Center, Department of Hematology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007812

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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