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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000006604
Date of registration: 24/10/2011
Prospective Registration: Yes
Primary sponsor: Japan Community Health care Organization Kyoto kuramaguchi Medical Center, Department of Hematology
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.
Scientific title:
Date of first enrolment: 2011/11/01
Target sample size: 21
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007812
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Phase I,II
Countries of recruitment
Japan
Contacts
Name: Yukio Ando   
Address:  1-1-1 Honjo, Kumamoto city, Kumamoto prefecture Japan
Telephone: 096-373-5893
Email: amyloid@fc.kuh.kumamoto-u.ac.jp
Affiliation:  Kumamoto University Faculty of life science, Department of Diagnostic Medicine
Name: Chihiro Shimazaki   
Address:  27 koyamashimofusa-cho,kita-ku,Kyoto Japan
Telephone: 075-441-6101
Email: simazaki@shaho-kyothsp.jp
Affiliation:  Japan Community Health care Organization Kyoyo kuramaguchi Medical Center Department of Hematology
Key inclusion & exclusion criteria
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

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


Age minimum: 20years-old
Age maximum: 65years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
To evaluate the efficacy and safety of the combination treatment melpharan, dexamethasone and bortezomib (BMD treatment) for relapsed or refractory systemic AL amyloidosis.
Intervention(s)
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.
Primary Outcome(s)
Hematological response rate post 6 months treatment
Secondary Outcome(s)
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
Secondary ID(s)
Source(s) of Monetary Support
Janssen Pharmaceutical K.K (Investigational drug provider)
Japanese Ministry of Health, Labour and Welfare
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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