Multiple MyelomaNCT00898235
Collection of Samples and Clinical Data From Patients With Amyloid Diseases
An observational study of Multiple Myeloma, run by Boston Medical Center at 1 site in United States.
Trial summary
RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients with amyloid diseases to test in the laboratory may help the study of this disease in the future. PURPOSE: This research study is collecting samples from patients with amyloid diseases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- clonality analysis, polymerase chain reaction and protein analysis
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed, or with suspicion of having, amyloidosis
Who may be able to join
- DISEASE CHARACTERISTICS:
- Diagnosis or suspicion of amyloidosis
- PATIENT CHARACTERISTICS:
- Referred to the Amyloid Treatment and Research Center at Boston University Medical Center
- PRIOR CONCURRENT THERAPY:
- Not specified
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston University Cancer Research Center
Boston, Massachusetts, 02118
Clinical Trials Office - Boston University Cancer Research Cen, 617-638-8265
About this study
Official title: Data, Tissue, Blood, and Urine Repository for Amyloid Diseases
RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients with amyloid diseases to test in the laboratory may help the study of this disease in the future.
PURPOSE: This research study is collecting samples from patients with amyloid diseases
Read the detailed description
OBJECTIVES:
- To establish and maintain a database of clinical material (i.e., blood, urine, and tissue) and information on patients with amyloid diseases.
OUTLINE: Blood, urine, tissue, and bone marrow samples are collected during standard laboratory evaluations to maintain a repository of biospecimens in the Gerry Amyloid Research Laboratory, to permit the correlation of clinical results with measured biological events, and for future research studies. Bone marrow RNA samples are examined for immunoglobulin light-chain gene sequences and amino acids by polymerase chain reaction and positional cloning. Blood serum and urine samples are evaluated for amyloid protein stability by high-resolution calorimetry, isothermal-titration calorimetry, and far- and near-UV circular dichroism and fluorescence spectroscopy. Urine samples are also examined for post-translational modifications (e.g., glycosylation, sulfation, and cross-linking) to identify common features unique to amyloid proteins. Tissue samples are analyzed for biochemical and biophysical properties and for post-translational modifications in light chains.
Quality of life is assessed by the 36-Item Short Form Survey (SF-36).
- Conditions
- Multiple Myeloma
- Being tested
- clonality analysis, polymerase chain reaction, protein analysis, biologic sample preservation procedure, laboratory biomarker analysis
- Keywords
- primary systemic amyloidosis
- Medical subject headings
- Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonality analysisGenetic
analyze clonality
polymerase chain reactionGenetic
analyze polymerase chain reaction
protein analysisGenetic
analyze protein
biologic sample preservation procedureOther
preserve biologic samples
laboratory biomarker analysisOther
analyze laboratory biomarkers
fluorescence spectroscopyProcedure or surgery
perform fluorescence spectroscopy on specimens
quality-of-life assessmentProcedure or surgery
assess quality of life at each follow-up for life
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a repository to promote biochemical research
Measured: life of study
Secondary outcomes (1)
Collection of clinical material and information
Measured: life of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJan 2000
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vaishali Sanchorawala, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898235
- Sponsor's protocol ID
- H-22838
- Other IDs
- CDR0000632869
- Status last verified
- Nov 2025
- First submitted
- 9 May 2009
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramireddy S, Prokaeva T, Chen H, Spencer B, Wong S, Dasari S, Dao L, McPhail ED, Sanchorawala V, Mendelson L. The Amyloidosis Intersection: Dual Amyloid Types in a Single Host. Eur J Haematol. 2025 Sep;115(3):287-298. doi: 10.1111/ejh.14429. Epub 2025 Jun 17.
PubMed 40526008Staron A, Burks EJ, Lee JC, Sarosiek S, Sloan JM, Sanchorawala V. Assessment of minimal residual disease using multiparametric flow cytometry in patients with AL amyloidosis. Blood Adv. 2020 Mar 10;4(5):880-884. doi: 10.1182/bloodadvances.2019001331.
PubMed 32130406Staron A, Connors LH, Ruberg FL, Mendelson LM, Sanchorawala V. A new era of amyloidosis: the trends at a major US referral centre. Amyloid. 2019 Dec;26(4):192-196. doi: 10.1080/13506129.2019.1640672. Epub 2019 Jul 15.
PubMed 31306033Lilleness B, Ruberg FL, Mussinelli R, Doros G, Sanchorawala V. Development and validation of a survival staging system incorporating BNP in patients with light chain amyloidosis. Blood. 2019 Jan 17;133(3):215-223. doi: 10.1182/blood-2018-06-858951. Epub 2018 Oct 17.
PubMed 30333122Shu J, Lo S, Phillips M, Sun F, Seldin DC, Berenbaum I, Berk JL, Sanchorawala V. Depression and anxiety in patients with AL amyloidosis as assessed by the SF-36 questionnaire: experience in 1226 patients. Amyloid. 2016 Sep;23(3):188-193. doi: 10.1080/13506129.2016.1208081. Epub 2016 Jul 27.
PubMed 27460276Cowan AJ, Skinner M, Seldin DC, Berk JL, Lichtenstein DR, O'Hara CJ, Doros G, Sanchorawala V. Amyloidosis of the gastrointestinal tract: a 13-year, single-center, referral experience. Haematologica. 2013 Jan;98(1):141-6. doi: 10.3324/haematol.2012.068155. Epub 2012 Jun 24.
PubMed 22733017
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data, Tissue, Blood, and Urine Repository for Amyloid Diseases
- ClinicalTrials.gov ID
- NCT00898235
- Acronym / sponsor ID
- H-22838
- Conditions
- Multiple Myeloma
- Keywords
- primary systemic amyloidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jan 2000 (actual)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 12 May 2009 (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.
RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients with amyloid diseases to test in the laboratory may help the study of this disease in the future.
PURPOSE: This research study is collecting samples from patients with amyloid diseases
Detailed description
OBJECTIVES:
- To establish and maintain a database of clinical material (i.e., blood, urine, and tissue) and information on patients with amyloid diseases.
OUTLINE: Blood, urine, tissue, and bone marrow samples are collected during standard laboratory evaluations to maintain a repository of biospecimens in the Gerry Amyloid Research Laboratory, to permit the correlation of clinical results with measured biological events, and for future research studies. Bone marrow RNA samples are examined for immunoglobulin light-chain gene sequences and amino acids by polymerase chain reaction and positional cloning. Blood serum and urine samples are evaluated for amyloid protein stability by high-resolution calorimetry, isothermal-titration calorimetry, and far- and near-UV circular dichroism and fluorescence spectroscopy. Urine samples are also examined for post-translational modifications (e.g., glycosylation, sulfation, and cross-linking) to identify common features unique to amyloid proteins. Tissue samples are analyzed for biochemical and biophysical properties and for post-translational modifications in light chains.
Quality of life is assessed by the 36-Item Short Form Survey (SF-36).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed, or with suspicion of having, amyloidosis
Key inclusion criteria (6 listed)
- Diagnosis or suspicion of amyloidosis
- Referred to the Amyloid Treatment and Research Center at Boston University Medical Center
- Not specified
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| clonality analysisanalyze clonality | Genetic | – |
| polymerase chain reactionanalyze polymerase chain reaction | Genetic | – |
| protein analysisanalyze protein | Genetic | – |
| biologic sample preservation procedurepreserve biologic samples | Other | – |
| laboratory biomarker analysisanalyze laboratory biomarkers | Other | – |
| fluorescence spectroscopyperform fluorescence spectroscopy on specimens | Procedure or surgery | – |
| quality-of-life assessmentassess quality of life at each follow-up for life | Procedure or surgery | – |
Primary outcome
Establish a repository to promote biochemical research
Time frame: life of study
1 secondary outcome
Collection of clinical material and information
Time frame: life of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Derived from this study: PubMed 40526008Ramireddy S, Prokaeva T, Chen H, Spencer B, Wong S, Dasari S, Dao L, McPhail ED, Sanchorawala V, Mendelson L. The Amyloidosis Intersection: Dual Amyloid Types in a Single Host. Eur J Haematol. 2025 Sep;115(3):287-298. doi: 10.1111/ejh.14429. Epub 2025 Jun 17.
- Derived from this study: PubMed 32130406Staron A, Burks EJ, Lee JC, Sarosiek S, Sloan JM, Sanchorawala V. Assessment of minimal residual disease using multiparametric flow cytometry in patients with AL amyloidosis. Blood Adv. 2020 Mar 10;4(5):880-884. doi: 10.1182/bloodadvances.2019001331.
- Derived from this study: PubMed 31306033Staron A, Connors LH, Ruberg FL, Mendelson LM, Sanchorawala V. A new era of amyloidosis: the trends at a major US referral centre. Amyloid. 2019 Dec;26(4):192-196. doi: 10.1080/13506129.2019.1640672. Epub 2019 Jul 15.
- Derived from this study: PubMed 30333122Lilleness B, Ruberg FL, Mussinelli R, Doros G, Sanchorawala V. Development and validation of a survival staging system incorporating BNP in patients with light chain amyloidosis. Blood. 2019 Jan 17;133(3):215-223. doi: 10.1182/blood-2018-06-858951. Epub 2018 Oct 17.
- Derived from this study: PubMed 27460276Shu J, Lo S, Phillips M, Sun F, Seldin DC, Berenbaum I, Berk JL, Sanchorawala V. Depression and anxiety in patients with AL amyloidosis as assessed by the SF-36 questionnaire: experience in 1226 patients. Amyloid. 2016 Sep;23(3):188-193. doi: 10.1080/13506129.2016.1208081. Epub 2016 Jul 27.
- Derived from this study: PubMed 22733017Cowan AJ, Skinner M, Seldin DC, Berk JL, Lichtenstein DR, O'Hara CJ, Doros G, Sanchorawala V. Amyloidosis of the gastrointestinal tract: a 13-year, single-center, referral experience. Haematologica. 2013 Jan;98(1):141-6. doi: 10.3324/haematol.2012.068155. Epub 2012 Jun 24.
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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.
Vaishali Sanchorawala, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Boston Medical Center 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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Dec 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vaishali Sanchorawala, MD (617-638-8261, vaishali.sanchorawala@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a repository to promote biochemical research (time frame: life of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00898235, which also lists 6 linked publications.
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 1 Dec 2025.