AmyloidosisPhase 2NCT00186407
Autologous Stem Cell Rescue for Primary Amyloidosis
A Phase 2 study testing high dose chemo then auto hematopoietic cell transplant in people with Amyloidosis and Blood and Marrow Transplant (BMT), run by Stanford University at 1 site in United States.
Trial summary
To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amyloidosis, Blood and Marrow Transplant (BMT)
- What is being tested?
- high dose chemo then auto hematopoietic cell transplant
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1998to Feb 2010
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2. Age < 75 years.
- 3. Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
- 4. Patients who have undergone bone marrow transplantation previously will not be eligible.
- 5. Patients must have a Karnofsky performance status greater than 70%.
- 6. Patients must have a serum creatinine less than 2 mg/dl or creatinine clearance greater than 30 ml/min, bilirubin less than 2 mg/dl, transaminases less than two times normal, left ventricular ejection fraction >45% on echocardiography, cardiac index > 1.8 liters/min/m^2 and pulmonary function tests demonstrating FEV1 and DLCO > 60%.
- 7. Patients must be HIV negative.
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- 8. Pregnant or lactating women will not be eligible to participate.
- 9. Patients must provide signed informed consent.
- 10. Patients with multiple myeloma and amyloid are eligible.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis
To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis.
Read the detailed description
To learn about the use of high dose chemotherapy followed by transplantation using peripheral blood stem cells.
- Conditions
- Amyloidosis, Blood and Marrow Transplant (BMT)
- Being tested
- high dose chemo then auto hematopoietic cell transplant
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dose chemo then auto hematopoietic cell transplantProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 1998
- Primary completionFeb 2008
- Study completionFeb 2010
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- Sally Arai, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186407
- Sponsor's protocol ID
- BMT92
- Other IDs
- 76379, BMT92, NCT00186407
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2005
- Last updated
- 14 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis
- ClinicalTrials.gov ID
- NCT00186407
- Acronym / sponsor ID
- BMT92
- Conditions
- Amyloidosis, Blood and Marrow Transplant (BMT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 1998
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Sep 2005 (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 role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis.
Detailed description
To learn about the use of high dose chemotherapy followed by transplantation using peripheral blood stem cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 2. Age < 75 years.
- 3. Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
- 4. Patients who have undergone bone marrow transplantation previously will not be eligible.
- 5. Patients must have a Karnofsky performance status greater than 70%.
- 6. Patients must have a serum creatinine less than 2 mg/dl or creatinine clearance greater than 30 ml/min, bilirubin less than 2 mg/dl, transaminases less than two times normal, left ventricular ejection fraction >45% on echocardiography, cardiac index > 1.8 liters/min/m^2 and pulmonary function tests demonstrating FEV1 and DLCO > 60%.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| high dose chemo then auto hematopoietic cell transplant | Procedure or surgery | – |
Primary outcome
To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis
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 14 Sep 2010.
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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.
Sally Arai principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing high dose chemo then auto hematopoietic cell transplant in people with Amyloidosis and Blood and Marrow Transplant (BMT), run by Stanford University at 1 site in United States.
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 9 inclusion and 0 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 14 Sep 2010. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis. 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 14 Sep 2010.