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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.
Last refreshed on: 19 February 2015
Main ID:  NCT01998503
Date of registration: 15/11/2013
Prospective Registration: No
Primary sponsor: Nanjing University School of Medicine
Public title: Bortezomib and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL Amyloidosis
Scientific title: Induction Therapy With Bortezomib and Dexamethasone Followed by Autologous Stem Cell Transplantation Versus Autologous Stem Cell Transplantation Alone in the Treatment of AL Amyloidosis
Date of first enrolment: December 2007
Target sample size: 56
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Name:     Zhihong Liu, MD
Affiliation:  Jinling Hospital, China
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with newly diagnosed AL amyloidosis

- Abnormal M protein or free light chain detected in serum and/or urine

- ECOG score 0-2 points

- No absolute neutrophil count of ANC less than or equal to 1000 within 14 days before

- No platelet count of less than or equal to 50K within 14 days before enrollment

- Serum bilirubin must lower than 2.0 mg/dl within 14 days before enrollment

- Serum creatinine must lower than 2.0 mg/dl within 14 days before enrollment

- Must have LVEF at least 45% by ECHO within 14 days of enrollment

- Pulmonary Function Tests must show DLCO at least 50%

Exclusion Criteria:

- Subjects have received or are currently receiving systematic treatment with steroids
(not including an emergent short-term use of steroids before randomization up to 4
days, maximum dose of 40mg/d)

- Pregnant and breastfeeding women, delivery term women or unwilling to take birth
control measures during the study

- Subjects suffering from multiple myeloma

- Grade 2 or more than grade 2 peripheral neuropathy or neuropathic pain according to
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
version 3

- Known or suspected hypersensitivity to dexamethasone, bortezomib, mannitol, boron, or
heparin (if use catheters)

- Subjects suffering from uncontrolled or severe cardiovascular disease, including
myocardial infarction, class III-IV heart failure defined by New York Heart
Association (NYHA), uncontrolled angina, clinical significant pericardial disease or
cardiac amyloidosis (Other contraindications are not suitable for transplant
patients) within 6 months before enrollment

- Subjects suffering from serious physical disease and mental illnesses which may
interfere the study

- Subjects receiving other pilot study or treatment within 4 weeks before enrollment

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Biological: filgrastim
Drug: Bortezomib
Drug: dexamethasone
Drug: Melphalan
Procedure: autologous hematopoietic stem cell transplantation (ASCT)
Primary Outcome(s)
Number of participants with hematologic complete response between BD+ASCT arm and ASCT alone arm in the treatment of AL amyloidosis [Time Frame: 12 months]
Secondary Outcome(s)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: 12 months]
Number of participants with organ responses between BD+ASCT arm and ASCT alone arm in the treatment of AL amyloidosis [Time Frame: 12 months]
Overall survival [Time Frame: 24 months]
Progression free survival [Time Frame: 24 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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