AmyloidosisNCT02485613
Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis
An observational study of Amyloidosis, run by Zhi-Hong Liu, M.D..
Trial summary
Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis, the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with AL amyloidosis should be determined. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyloidosis
- What is being tested?
- bortezominb and dexamethasone
- Type of treatment
- Injection or infusion
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from hospital，who were diagnosed AL amyloidosis by renal or other type biopsy.
Who may be able to join
- Female or male patients aged between 18 to 80 years
- Renal or other type biopsy was used to diagnose AL amyloidosis
- Understand and voluntarily sign an informed consent form
- ECOG score 0-3 points
- Adequate residual organ function
Who cannot join
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Grade 3 sensory or grade 1 painful peripheral neuropathy
- Known hypersensitivity to bortezomib, boron or mannitol
- Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure
- Clinically overt multiple myeloma
- Pregnant or nursing women.
About this study
Official title: Bortezomib With Dexamethasone as the First-line Treatment for Immunoglobulin Light Chain(AL) Amyloidosis
Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis, the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with AL amyloidosis should be determined. In this study, the investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.
Read the detailed description
This study included patients with newly diagnosed AL amyloidosis who were treated with a BD regimen in Jinling hospital. The AL amyloidosis diagnosis was confirmed by renal biopsy, and the assessment of organ involvement were based on consensus criteria. The clinical and laboratory data were collected at the beginning of each cycle and every 3 months thereafter. The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.
- Conditions
- Amyloidosis
- Being tested
- bortezominb and dexamethasone
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezominb and dexamethasoneDrug
Also called Velcade
The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The dose of bortezomib and dexamethasone can be adjusted according to the patients' condition.
| Study group | Role | What they receive |
|---|---|---|
| bortezominb and dexamethasone group | Not described Receives: Drug: bortezominb and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic response rate
Hematologic responses were evaluated according to the novel criteria of the International Society of Amyloidosis
Measured: 3 months
Secondary outcomes (3)
organ response rate
organ responses were evaluated according to the novel criteria of the International Society of Amyloidosis
Measured: 12 months
Overall survival
Measured: From date of the start of treatment to date of death,up to 3 months
Progression free survival
Measured: From date of the start of treatment to date of disease progression,up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJan 2009
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhi-Hong Liu, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhi-Hong Liu, M.D., Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485613
- Sponsor's protocol ID
- NJCT-1501
- Status last verified
- Jun 2015
- First submitted
- 24 Jun 2015
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bortezomib With Dexamethasone as the First-line Treatment for Immunoglobulin Light Chain(AL) Amyloidosis
- ClinicalTrials.gov ID
- NCT02485613
- Acronym / sponsor ID
- NJCT-1501
- Conditions
- Amyloidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Zhi-Hong Liu, M.D.University, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis, the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with AL amyloidosis should be determined. In this study, the investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.
Detailed description
This study included patients with newly diagnosed AL amyloidosis who were treated with a BD regimen in Jinling hospital. The AL amyloidosis diagnosis was confirmed by renal biopsy, and the assessment of organ involvement were based on consensus criteria. The clinical and laboratory data were collected at the beginning of each cycle and every 3 months thereafter. The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bortezominb and dexamethasone group | – | Drug: bortezominb and dexamethasone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from hospital，who were diagnosed AL amyloidosis by renal or other type biopsy.
Key inclusion criteria (5 listed)
- Female or male patients aged between 18 to 80 years
- Renal or other type biopsy was used to diagnose AL amyloidosis
- Understand and voluntarily sign an informed consent form
- ECOG score 0-3 points
- Adequate residual organ function
Key exclusion criteria (6 listed)
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Grade 3 sensory or grade 1 painful peripheral neuropathy
- Known hypersensitivity to bortezomib, boron or mannitol
- Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure
- Clinically overt multiple myeloma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezominb and dexamethasoneAlso: VelcadeThe initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The dose of bortezomib and dexamethasone can be adjusted according to the patients' condition. | Drug | bortezominb and dexamethasone group |
Primary outcome
Hematologic response rate
Time frame: 3 months
Hematologic responses were evaluated according to the novel criteria of the International Society of Amyloidosis
3 secondary outcomes
organ response rate
Time frame: 12 months
Overall survival
Time frame: From date of the start of treatment to date of death,up to 3 months
Progression free survival
Time frame: From date of the start of treatment to date of disease progression,up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloidosis, run by Zhi-Hong Liu, M.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic response rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.