AmyloidosisNCT01273844
Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)
A study testing Bortezomib in people with Amyloidosis, run by Zhi-Hong Liu, M.D. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone) followed by autologous hematopoietic stem cell transplantation as an initial treatment in patients with newly diagnosed AL. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amyloidosis
- What is being tested?
- Bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2011to 12 May 2016
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female;
- aged 18-65 years;
- Patients with newly diagnosed AL;
- Appropriate for autologous hematopoietic stem cell transplantation;
- Abnormal M protein or free light chain detected in serum and / or urine
- ECOG score 0-2 points;
- Subjects (or their legal representatives) must signed an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.
Who cannot join
- Subjects received systematic treatment with steroids
- Subjects received plasmapheresis to treat clinical significant hyperviscosity syndrome within 4 weeks before enrollment.
- Pregnant and breastfeeding women;
- Subjects suffering from multiple myeloma.
- hypersensitivity to dexamethasone, bortezomib, mannitol, boron, or heparin (if use catheters);
- Subjects have severe cardiovascular disease,
- Subjects have serious physical disease and mental illnesses which may interfere the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in AL
To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone) followed by autologous hematopoietic stem cell transplantation as an initial treatment in patients with newly diagnosed AL.
Read the detailed description
Patients will receive two 21-day cycles of induction therapy with vel / dex regimen. Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while Dexamethasone 40 mg/d will be taken orally on days 1-4. After two cycles of vel / dex therapy, the collection of peripheral blood stem cells (PBSC) should be completed within 4 weeks.Patients will receive ASCT therapy in 8 weeks after collection of PBSC (Recorded as day 0), while melphalan (day -2) with a dose of 100,140 or 200 mg/m2 (choosing a dose according to the degree of risk for patients ) and Vel 1mg/m2 (days -6, -3, +1, +4) will be given. Four additional 21-day cycles of Vel treatment (with a dose of 1.6mg/m2 on day 1 and 8 of the cycle) will be conducted as consolidation therapy during the recommended 60-90 days after HSCT, or after resumption of hematopoietic function ( neutrophil count > 1.5x109/L and platelet count> 50x109/L). Later patients won't need maintenance therapy.
The efficacy criteria are the international standards set with consensus of experts in the Tenth International Symposium on Amyloid and Amyloidosis.
- Conditions
- Amyloidosis
- Being tested
- Bortezomib
- Keywords
- hematopoietic stem cell transplantation, amyloidosis, Bortezomib
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called autologous hematopoietic stem cell transplantation
Bortezomib
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib | Experimental | Patients will receive two 21-day cycles of induction therapy with vel / dex regimen. Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while Dexamethasone 40 mg/d will be taken orally on days 1-4. Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Complete response rate at 12 months post-transplantation
Measured: 12 months
Secondary outcomes (1)
overall response rate
overall response rate(ie.,CR + PR) at 12 months post-transplantation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study start1 Mar 2011
- Primary completion12 May 2016
- Study completion12 May 2016
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhi-Hong Liu, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Soochow University, Nanjing Medical University
- Responsible party
- Sponsor-investigator, Zhi-Hong Liu, M.D., Nanjing University School of Medicine
- Investigators
- zhihong Liu, Master, Principal investigator, Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273844
- Sponsor's protocol ID
- NJCT-1006
- Status last verified
- Apr 2017
- First submitted
- 3 Jan 2011
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in AL
- ClinicalTrials.gov ID
- NCT01273844
- Acronym / sponsor ID
- NJCT-1006
- Conditions
- Amyloidosis
- Keywords
- hematopoietic stem cell transplantation, amyloidosis, Bortezomib
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Zhi-Hong Liu, M.D.University, hospital or other
- Collaborators
- Soochow University, Nanjing Medical University
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 12 May 2016 (actual)
- Study completion
- 12 May 2016 (actual)
- First posted
- 11 Jan 2011 (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.
To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone) followed by autologous hematopoietic stem cell transplantation as an initial treatment in patients with newly diagnosed AL.
Detailed description
Patients will receive two 21-day cycles of induction therapy with vel / dex regimen. Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while Dexamethasone 40 mg/d will be taken orally on days 1-4. After two cycles of vel / dex therapy, the collection of peripheral blood stem cells (PBSC) should be completed within 4 weeks.Patients will receive ASCT therapy in 8 weeks after collection of PBSC (Recorded as day 0), while melphalan (day -2) with a dose of 100,140 or 200 mg/m2 (choosing a dose according to the degree of risk for patients ) and Vel 1mg/m2 (days -6, -3, +1, +4) will be given. Four additional 21-day cycles of Vel treatment (with a dose of 1.6mg/m2 on day 1 and 8 of the cycle) will be conducted as consolidation therapy during the recommended 60-90 days after HSCT, or after resumption of hematopoietic function ( neutrophil count > 1.5x109/L and platelet count> 50x109/L). Later patients won't need maintenance therapy.
The efficacy criteria are the international standards set with consensus of experts in the Tenth International Symposium on Amyloid and Amyloidosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib | Experimental | Drug: BortezomibPatients will receive two 21-day cycles of induction therapy with vel / dex regimen. Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while Dexamethasone 40 mg/d will be taken orally on days 1-4. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female;
- aged 18-65 years;
- Patients with newly diagnosed AL;
- Appropriate for autologous hematopoietic stem cell transplantation;
- Abnormal M protein or free light chain detected in serum and / or urine
Key exclusion criteria (7 listed)
- Subjects received systematic treatment with steroids
- Subjects received plasmapheresis to treat clinical significant hyperviscosity syndrome within 4 weeks before enrollment.
- Pregnant and breastfeeding women;
- Subjects suffering from multiple myeloma.
- hypersensitivity to dexamethasone, bortezomib, mannitol, boron, or heparin (if use catheters);
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 |
|---|---|---|
| BortezomibAlso: autologous hematopoietic stem cell transplantationBortezomib | Drug | Bortezomib |
Primary outcome
Complete response rate
Time frame: 12 months
Complete response rate at 12 months post-transplantation
1 secondary outcome
overall response rate
Time frame: 12 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 7 Apr 2017.
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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.
zhihong Liu, Master principal investigator
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bortezomib in people with Amyloidosis, run by Zhi-Hong Liu, M.D. at 1 site in China.
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 7 inclusion and 7 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Complete response rate (time frame: 12 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 7 Apr 2017.