AmyloidosisNCT00186095
Mixed Chimeric Transplantation for Primary Amyloidosis
A study testing autologous followed by nonmyeloablative allogeneic transplant in people with Amyloidosis, run by Stanford University.
Trial summary
To evaluate the role of nonmyeloablative allogeneic transplantation in Amyloidosis. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Amyloidosis
- What is being tested?
- autologous followed by nonmyeloablative allogeneic transplant
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Sep 2006
- 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- primary amyloidosis
- adequate organ function
- matched sibling donor
Who cannot join
- evidence of multiple myeloma
- HIV positive
About this study
To evaluate the role of nonmyeloablative allogeneic transplantation in Amyloidosis.
- Conditions
- Amyloidosis
- Being tested
- autologous followed by nonmyeloablative allogeneic transplant
- Keywords
- Amyloidosis, nonmyeloablative, hematopoietic, cell transplantation
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous followed by nonmyeloablative allogeneic transplantProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of patients with nonmyeloablative allogeneic transplant for amyloidosis.
Secondary outcomes (3)
Toxicity of therapy
Changes in marrow and serum abnormalities
Improvement in end-organ function.
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 startDec 2000
- Study completionSep 2006
Why it stopped: Closed, never started.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- Keith Stockerl-Goldstein, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186095
- Sponsor's protocol ID
- BMT129
- Status last verified
- Jun 2022
- First submitted
- 13 Sep 2005
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Chimeric Transplantation for Primary Amyloidosis
- ClinicalTrials.gov ID
- NCT00186095
- Acronym / sponsor ID
- BMT129
- Conditions
- Amyloidosis
- Keywords
- Amyloidosis, nonmyeloablative, hematopoietic, cell transplantation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Closed, never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2000
- Study completion
- Sep 2006
- 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 nonmyeloablative allogeneic transplantation in Amyloidosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- primary amyloidosis
- adequate organ function
- matched sibling donor
Key exclusion criteria (2 listed)
- evidence of multiple myeloma
- HIV positive
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 |
|---|---|---|
| autologous followed by nonmyeloablative allogeneic transplant | Procedure or surgery | – |
Primary outcome
Treatment of patients with nonmyeloablative allogeneic transplant for amyloidosis.
3 secondary outcomes
Toxicity of therapy
Changes in marrow and serum abnormalities
Improvement in end-organ function.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
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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.
Keith Stockerl-Goldstein, MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing autologous followed by nonmyeloablative allogeneic transplant in people with Amyloidosis, run by Stanford University.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 Jun 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Treatment of patients with nonmyeloablative allogeneic 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 23 Jun 2022.