AmyloidosisNCT02555969
Minimal Residual Disease as a Possible Predictive Factor for Relapse in Patients With AL Amyloidosis
An observational study of Amyloidosis and Primary Amyloidosis, run by Tufts Medical Center at 1 site in United States.
Trial summary
This protocol will assess patients with AL amyloidosis who achieve a complete response (CR) or very good partial response (VGPR) to therapy for minimal residual disease (MRD). Three approaches to MRD testing will be used since there is no established method. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amyloidosis, Primary Amyloidosis
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will enroll AL amyloidosis patients at Tufts Medical Center who have baseline bone marrow cells available from the time of diagnosis, or from a time of therapy prior to achieving a response, and then subsequently achieve a CR or VGPR with first-line therapy. Up to 50 patients diagnosed with AL amyloidosis will be evaluated on this protocol.
Who may be able to join
- Patients with AL amyloidosis at Tufts Medical Center who have baseline bone marrow samples available and achieve a CR or VGPR to treatment. Patients may consent and register at diagnosis and have a baseline marrow collected at the time of consent; or patients may consent during therapy prior to achieving a response, if they have previously banked marrow cells for research.
Who cannot join
- Patients who do not have available baseline bone marrow samples.
Trial locations and contacts
1 site in 1 country.
About this study
This protocol will assess patients with AL amyloidosis who achieve a complete response (CR) or very good partial response (VGPR) to therapy for minimal residual disease (MRD). Three approaches to MRD testing will be used since there is no established method. The investigators will clone and sequence each patient's light chain (LC) gene and design patient-specific primers to evaluate genomic DNA from future marrow specimens. Whole genome sequencing (WGS) will be used to test baseline and follow-up marrow cell DNA, seeking copy number variations in chromosomes 1 and 2 or 22, and structural variations in chromosomes 11 and 14, consistent with the known genetic abnormalities in AL and with clonal LC gene use. Plasma protein analysis by mass spectrometry will also be used to look for fragmentary protein sequences associated with the culprit LC gene of each subject. The feasibility and predictive value of these three approaches in patients achieving CR or VGPR will be evaluated. This protocol will help provide insight into the ways that the disease changes and progresses. MRD testing is likely an important next step in AL management.
Read the detailed description
This protocol will assess AL amyloidosis patients who achieve a CR or VGPR to first-line therapy for evidence of MRD by Q-PCR, NGS, and plasma protein analysis by mass spectrometry using marrow cells obtained annually at times of standard clinical evaluations.
A bone marrow aspirate sample from diagnosis will be used to create a baseline profile of each patient's disease. This sample will allow the investigators to create the primer-probe sets required for MRD testing by Q-PCR, which will be conducted after the patient has achieved a CR or VGPR. A baseline bone marrow biopsy sample will either be taken at the time of consent or can be taken from storage if the patient has previously consented to have their marrow cells banked for research purposes. An extra 15 mL of aspirate will be taken from their diagnostic bone marrow biopsy, which is routinely conducted on newly diagnosed patients for clinical purposes. Annual bone marrow aspirates will not be taken for research purposes until after the patient has responded. Patients will remain on protocol, but only begin MRD testing after achieving a CR or VGPR to first-line therapy at which point annual marrow collections for MRD testing will begin. In the event the patient does not reach a CR or VGPR to first-line therapy, the baseline bone marrow aspirate from diagnosis will be discarded.
Patients who choose to allow their marrow to be used in this study will sign a consent form specifically for this study. At the time of consent, three green top tubes of peripheral blood will be obtained for WGS of non-tumor cells. No further blood samples will be required for this study. After achieving a CR or VGPR, patients will be completely re-staged as is standard of care at annual intervals. Samples to test for the presence of MRD in their marrows will be obtained at these times of clinical re-staging for up to 3 years after their response to therapy. Both blood and bone marrow samples for this study will be immediately taken to an on-site laboratory where they will be briefly stored before testing. This will ensure no study samples interfere with routine clinical care.
In order to test for the presence of MRD, three techniques will be used: Q-PCR, WGS, and plasma protein analysis by mass spectrometry. Both Q-PCR and WGS will use genomic DNA from marrow aspirate samples. To make primer-probe sets for Q-PCR, bone marrow samples from baseline will be used to create individualized primer-probe sets that can recognize the genetically unique LC gene that causes each patient's disease. To perform WGS, genomic DNA will be supplied to the core genetics laboratory for creation of a library and multiplex next generation sequencing. To perform plasma protein analysis, plasma will be isolated from a portion of each subject's peripheral blood and bone marrow aspirate samples in an on-site laboratory. Each subject's de-identified LC gene sequence and their de-identified plasma samples will then be sent to Memorial Sloan-Kettering Cancer Center (MSKCC) for mass spectrometry to look for fragmentary protein sequences associated with the culprit LC gene of each subject.
After reaching a CR or VGPR, at annual evaluations for up to 3 years, the genomic DNA from the research sample of bone marrow collected during standard of care clinical procedures will be used to confirm maintenance of response by testing for the presence of MRD with each of the 3 methods (Q-PCR, WGS, and plasma protein analysis) noted above. Marrow material collected for the purposes of this study will not be stored after analysis, and primer-probe set design will be conducted entirely within Tufts Medical Center. Any marrow samples not fully consumed during analysis will be destroyed.
By using these three methods this protocol will determine whether one method is superior to the others and whether the three methods produce results that correlate with each other. The decision to discontinue participation in MRD testing will be made by the patient and the physician on an individual basis. Patients who have relapse or hematologic progression of disease during the three year period by standard blood and urine tests will no longer have testing for MRD.
- Conditions
- Amyloidosis, Primary Amyloidosis
- Medical subject headings
- Amyloidosis, Immunoglobulin Light-chain Amyloidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Residual Disease Testing by Q-PCR, NGS, and mass spectrometry
After achievement of a CR or VGPR, minimal residual disease testing (using Q-PCR, WGS, and plasma protein analysis by mass spectrometry) will be done annually for up to 3 years. These tests will show either the presence of absence of minimal residual disease. These findings will then be correlated with progression free survival as assessed through standard clinical tests for AL amyloidosis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymond Comenzo, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555969
- Sponsor's protocol ID
- 11829
- Status last verified
- Aug 2020
- First submitted
- 16 Sep 2015
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Abraham RS, Geyer SM, Price-Troska TL, Allmer C, Kyle RA, Gertz MA, Fonseca R. Immunoglobulin light chain variable (V) region genes influence clinical presentation and outcome in light chain-associated amyloidosis (AL). Blood. 2003 May 15;101(10):3801-8. doi: 10.1182/blood-2002-09-2707. Epub 2002 Dec 19.
PubMed 12515719Perfetti V, Casarini S, Palladini G, Vignarelli MC, Klersy C, Diegoli M, Ascari E, Merlini G. Analysis of V(lambda)-J(lambda) expression in plasma cells from primary (AL) amyloidosis and normal bone marrow identifies 3r (lambdaIII) as a new amyloid-associated germline gene segment. Blood. 2002 Aug 1;100(3):948-53. doi: 10.1182/blood-2002-01-0114.
PubMed 12130507Bodi K, Prokaeva T, Spencer B, Eberhard M, Connors LH, Seldin DC. AL-Base: a visual platform analysis tool for the study of amyloidogenic immunoglobulin light chain sequences. Amyloid. 2009 Mar;16(1):1-8. doi: 10.1080/13506120802676781.
PubMed 19291508Comenzo RL. Plasma cell neoplasms, their precursor States, and their prediction of organ damage. J Clin Oncol. 2014 Sep 1;32(25):2679-82. doi: 10.1200/JCO.2014.56.2892. Epub 2014 Jul 14. No abstract available.
PubMed 25024079Comenzo RL, Wally J, Kica G, Murray J, Ericsson T, Skinner M, Zhang Y. Clonal immunoglobulin light chain variable region germline gene use in AL amyloidosis: association with dominant amyloid-related organ involvement and survival after stem cell transplantation. Br J Haematol. 1999 Sep;106(3):744-51. doi: 10.1046/j.1365-2141.1999.01591.x.
PubMed 10468868Comenzo RL, Zhang Y, Martinez C, Osman K, Herrera GA. The tropism of organ involvement in primary systemic amyloidosis: contributions of Ig V(L) germ line gene use and clonal plasma cell burden. Blood. 2001 Aug 1;98(3):714-20. doi: 10.1182/blood.v98.3.714.
PubMed 11468171Dasari S, Theis JD, Vrana JA, Meureta OM, Quint PS, Muppa P, Zenka RM, Tschumper RC, Jelinek DF, Davila JI, Sarangi V, Kurtin PJ, Dogan A. Proteomic detection of immunoglobulin light chain variable region peptides from amyloidosis patient biopsies. J Proteome Res. 2015 Apr 3;14(4):1957-67. doi: 10.1021/acs.jproteome.5b00015. Epub 2015 Mar 20.
PubMed 25734799van der Velden VH, Cazzaniga G, Schrauder A, Hancock J, Bader P, Panzer-Grumayer ER, Flohr T, Sutton R, Cave H, Madsen HO, Cayuela JM, Trka J, Eckert C, Foroni L, Zur Stadt U, Beldjord K, Raff T, van der Schoot CE, van Dongen JJ; European Study Group on MRD detection in ALL (ESG-MRD-ALL). Analysis of minimal residual disease by Ig/TCR gene rearrangements: guidelines for interpretation of real-time quantitative PCR data. Leukemia. 2007 Apr;21(4):604-11. doi: 10.1038/sj.leu.2404586. Epub 2007 Feb 8.
PubMed 17287850Wang Q, Xia J, Jia P, Pao W, Zhao Z. Application of next generation sequencing to human gene fusion detection: computational tools, features and perspectives. Brief Bioinform. 2013 Jul;14(4):506-19. doi: 10.1093/bib/bbs044. Epub 2012 Aug 9.
PubMed 22877769Welschof M, Terness P, Kolbinger F, Zewe M, Dubel S, Dorsam H, Hain C, Finger M, Jung M, Moldenhauer G, et al. Amino acid sequence based PCR primers for amplification of rearranged human heavy and light chain immunoglobulin variable region genes. J Immunol Methods. 1995 Feb 27;179(2):203-14. doi: 10.1016/0022-1759(94)00286-6.
PubMed 7876568Zhou P, Comenzo RL, Olshen AB, Bonvini E, Koenig S, Maslak PG, Fleisher M, Hoffman J, Jhanwar S, Young JW, Nimer SD, Boruchov AM. CD32B is highly expressed on clonal plasma cells from patients with systemic light-chain amyloidosis and provides a target for monoclonal antibody-based therapy. Blood. 2008 Apr 1;111(7):3403-6. doi: 10.1182/blood-2007-11-125526. Epub 2008 Jan 23.
PubMed 18216299Zhou P, Hoffman J, Landau H, Hassoun H, Iyer L, Comenzo RL. Clonal plasma cell pathophysiology and clinical features of disease are linked to clonal plasma cell expression of cyclin D1 in systemic light-chain amyloidosis. Clin Lymphoma Myeloma Leuk. 2012 Feb;12(1):49-58. doi: 10.1016/j.clml.2011.09.217. Epub 2011 Nov 18.
PubMed 22100494Zhou P, Ma X, Iyer L, Chaulagain C, Comenzo RL. One siRNA pool targeting the lambda constant region stops lambda light-chain production and causes terminal endoplasmic reticulum stress. Blood. 2014 May 29;123(22):3440-51. doi: 10.1182/blood-2013-10-535187. Epub 2014 Apr 10.
PubMed 24723680Zhao M, Wang Q, Wang Q, Jia P, Zhao Z. Computational tools for copy number variation (CNV) detection using next-generation sequencing data: features and perspectives. BMC Bioinformatics. 2013;14 Suppl 11(Suppl 11):S1. doi: 10.1186/1471-2105-14-S11-S1. Epub 2013 Sep 13.
PubMed 24564169Zhou P, Zhang Y, Martinez C, Kalakonda N, Nimer SD, Comenzo RL. Melphalan-mobilized blood stem cell components contain minimal clonotypic myeloma cell contamination. Blood. 2003 Jul 15;102(2):477-9. doi: 10.1182/blood-2002-12-3674. Epub 2003 Mar 20.
PubMed 12649134
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Residual Disease as a Possible Predictive Factor for Relapse in Patients With AL Amyloidosis
- ClinicalTrials.gov ID
- NCT02555969
- Acronym / sponsor ID
- 11829
- Conditions
- Amyloidosis, Primary Amyloidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 22 Sep 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.
This protocol will assess patients with AL amyloidosis who achieve a complete response (CR) or very good partial response (VGPR) to therapy for minimal residual disease (MRD). Three approaches to MRD testing will be used since there is no established method. The investigators will clone and sequence each patient's light chain (LC) gene and design patient-specific primers to evaluate genomic DNA from future marrow specimens. Whole genome sequencing (WGS) will be used to test baseline and follow-up marrow cell DNA, seeking copy number variations in chromosomes 1 and 2 or 22, and structural variations in chromosomes 11 and 14, consistent with the known genetic abnormalities in AL and with clonal LC gene use. Plasma protein analysis by mass spectrometry will also be used to look for fragmentary protein sequences associated with the culprit LC gene of each subject. The feasibility and predictive value of these three approaches in patients achieving CR or VGPR will be evaluated. This protocol will help provide insight into the ways that the disease changes and progresses. MRD testing is likely an important next step in AL management.
Detailed description
This protocol will assess AL amyloidosis patients who achieve a CR or VGPR to first-line therapy for evidence of MRD by Q-PCR, NGS, and plasma protein analysis by mass spectrometry using marrow cells obtained annually at times of standard clinical evaluations.
A bone marrow aspirate sample from diagnosis will be used to create a baseline profile of each patient's disease. This sample will allow the investigators to create the primer-probe sets required for MRD testing by Q-PCR, which will be conducted after the patient has achieved a CR or VGPR. A baseline bone marrow biopsy sample will either be taken at the time of consent or can be taken from storage if the patient has previously consented to have their marrow cells banked for research purposes. An extra 15 mL of aspirate will be taken from their diagnostic bone marrow biopsy, which is routinely conducted on newly diagnosed patients for clinical purposes. Annual bone marrow aspirates will not be taken for research purposes until after the patient has responded. Patients will remain on protocol, but only begin MRD testing after achieving a CR or VGPR to first-line therapy at which point annual marrow collections for MRD testing will begin. In the event the patient does not reach a CR or VGPR to first-line therapy, the baseline bone marrow aspirate from diagnosis will be discarded.
Patients who choose to allow their marrow to be used in this study will sign a consent form specifically for this study. At the time of consent, three green top tubes of peripheral blood will be obtained for WGS of non-tumor cells. No further blood samples will be required for this study. After achieving a CR or VGPR, patients will be completely re-staged as is standard of care at annual intervals. Samples to test for the presence of MRD in their marrows will be obtained at these times of clinical re-staging for up to 3 years after their response to therapy. Both blood and bone marrow samples for this study will be immediately taken to an on-site laboratory where they will be briefly stored before testing. This will ensure no study samples interfere with routine clinical care.
In order to test for the presence of MRD, three techniques will be used: Q-PCR, WGS, and plasma protein analysis by mass spectrometry. Both Q-PCR and WGS will use genomic DNA from marrow aspirate samples. To make primer-probe sets for Q-PCR, bone marrow samples from baseline will be used to create individualized primer-probe sets that can recognize the genetically unique LC gene that causes each patient's disease. To perform WGS, genomic DNA will be supplied to the core genetics laboratory for creation of a library and multiplex next generation sequencing. To perform plasma protein analysis, plasma will be isolated from a portion of each subject's peripheral blood and bone marrow aspirate samples in an on-site laboratory. Each subject's de-identified LC gene sequence and their de-identified plasma samples will then be sent to Memorial Sloan-Kettering Cancer Center (MSKCC) for mass spectrometry to look for fragmentary protein sequences associated with the culprit LC gene of each subject.
After reaching a CR or VGPR, at annual evaluations for up to 3 years, the genomic DNA from the research sample of bone marrow collected during standard of care clinical procedures will be used to confirm maintenance of response by testing for the presence of MRD with each of the 3 methods (Q-PCR, WGS, and plasma protein analysis) noted above. Marrow material collected for the purposes of this study will not be stored after analysis, and primer-probe set design will be conducted entirely within Tufts Medical Center. Any marrow samples not fully consumed during analysis will be destroyed.
By using these three methods this protocol will determine whether one method is superior to the others and whether the three methods produce results that correlate with each other. The decision to discontinue participation in MRD testing will be made by the patient and the physician on an individual basis. Patients who have relapse or hematologic progression of disease during the three year period by standard blood and urine tests will no longer have testing for MRD.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will enroll AL amyloidosis patients at Tufts Medical Center who have baseline bone marrow cells available from the time of diagnosis, or from a time of therapy prior to achieving a response, and then subsequently achieve a CR or VGPR with first-line therapy. Up to 50 patients diagnosed with AL amyloidosis will be evaluated on this protocol.
Key inclusion criteria (1 listed)
- Patients with AL amyloidosis at Tufts Medical Center who have baseline bone marrow samples available and achieve a CR or VGPR to treatment. Patients may consent and register at diagnosis and have a baseline marrow collected at the time of consent; or patients may consent during therapy prior to achieving a response, if they have previously banked marrow cells for research.
Key exclusion criteria (1 listed)
- Patients who do not have available baseline bone marrow samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Minimal Residual Disease Testing by Q-PCR, NGS, and mass spectrometry
Time frame: 3 years
After achievement of a CR or VGPR, minimal residual disease testing (using Q-PCR, WGS, and plasma protein analysis by mass spectrometry) will be done annually for up to 3 years. These tests will show either the presence of absence of minimal residual disease. These findings will then be correlated with progression free survival as assessed through standard clinical tests for AL 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 24 Aug 2020.
- Background: PubMed 12515719Abraham RS, Geyer SM, Price-Troska TL, Allmer C, Kyle RA, Gertz MA, Fonseca R. Immunoglobulin light chain variable (V) region genes influence clinical presentation and outcome in light chain-associated amyloidosis (AL). Blood. 2003 May 15;101(10):3801-8. doi: 10.1182/blood-2002-09-2707. Epub 2002 Dec 19.
- Background: PubMed 12130507Perfetti V, Casarini S, Palladini G, Vignarelli MC, Klersy C, Diegoli M, Ascari E, Merlini G. Analysis of V(lambda)-J(lambda) expression in plasma cells from primary (AL) amyloidosis and normal bone marrow identifies 3r (lambdaIII) as a new amyloid-associated germline gene segment. Blood. 2002 Aug 1;100(3):948-53. doi: 10.1182/blood-2002-01-0114.
- Background: PubMed 19291508Bodi K, Prokaeva T, Spencer B, Eberhard M, Connors LH, Seldin DC. AL-Base: a visual platform analysis tool for the study of amyloidogenic immunoglobulin light chain sequences. Amyloid. 2009 Mar;16(1):1-8. doi: 10.1080/13506120802676781.
- Background: PubMed 25024079Comenzo RL. Plasma cell neoplasms, their precursor States, and their prediction of organ damage. J Clin Oncol. 2014 Sep 1;32(25):2679-82. doi: 10.1200/JCO.2014.56.2892. Epub 2014 Jul 14. No abstract available.
- Background: PubMed 10468868Comenzo RL, Wally J, Kica G, Murray J, Ericsson T, Skinner M, Zhang Y. Clonal immunoglobulin light chain variable region germline gene use in AL amyloidosis: association with dominant amyloid-related organ involvement and survival after stem cell transplantation. Br J Haematol. 1999 Sep;106(3):744-51. doi: 10.1046/j.1365-2141.1999.01591.x.
- Background: PubMed 11468171Comenzo RL, Zhang Y, Martinez C, Osman K, Herrera GA. The tropism of organ involvement in primary systemic amyloidosis: contributions of Ig V(L) germ line gene use and clonal plasma cell burden. Blood. 2001 Aug 1;98(3):714-20. doi: 10.1182/blood.v98.3.714.
- Background: PubMed 25734799Dasari S, Theis JD, Vrana JA, Meureta OM, Quint PS, Muppa P, Zenka RM, Tschumper RC, Jelinek DF, Davila JI, Sarangi V, Kurtin PJ, Dogan A. Proteomic detection of immunoglobulin light chain variable region peptides from amyloidosis patient biopsies. J Proteome Res. 2015 Apr 3;14(4):1957-67. doi: 10.1021/acs.jproteome.5b00015. Epub 2015 Mar 20.
- Background: PubMed 17287850van der Velden VH, Cazzaniga G, Schrauder A, Hancock J, Bader P, Panzer-Grumayer ER, Flohr T, Sutton R, Cave H, Madsen HO, Cayuela JM, Trka J, Eckert C, Foroni L, Zur Stadt U, Beldjord K, Raff T, van der Schoot CE, van Dongen JJ; European Study Group on MRD detection in ALL (ESG-MRD-ALL). Analysis of minimal residual disease by Ig/TCR gene rearrangements: guidelines for interpretation of real-time quantitative PCR data. Leukemia. 2007 Apr;21(4):604-11. doi: 10.1038/sj.leu.2404586. Epub 2007 Feb 8.
- Background: PubMed 22877769Wang Q, Xia J, Jia P, Pao W, Zhao Z. Application of next generation sequencing to human gene fusion detection: computational tools, features and perspectives. Brief Bioinform. 2013 Jul;14(4):506-19. doi: 10.1093/bib/bbs044. Epub 2012 Aug 9.
- Background: PubMed 7876568Welschof M, Terness P, Kolbinger F, Zewe M, Dubel S, Dorsam H, Hain C, Finger M, Jung M, Moldenhauer G, et al. Amino acid sequence based PCR primers for amplification of rearranged human heavy and light chain immunoglobulin variable region genes. J Immunol Methods. 1995 Feb 27;179(2):203-14. doi: 10.1016/0022-1759(94)00286-6.
- Background: PubMed 18216299Zhou P, Comenzo RL, Olshen AB, Bonvini E, Koenig S, Maslak PG, Fleisher M, Hoffman J, Jhanwar S, Young JW, Nimer SD, Boruchov AM. CD32B is highly expressed on clonal plasma cells from patients with systemic light-chain amyloidosis and provides a target for monoclonal antibody-based therapy. Blood. 2008 Apr 1;111(7):3403-6. doi: 10.1182/blood-2007-11-125526. Epub 2008 Jan 23.
- Background: PubMed 22100494Zhou P, Hoffman J, Landau H, Hassoun H, Iyer L, Comenzo RL. Clonal plasma cell pathophysiology and clinical features of disease are linked to clonal plasma cell expression of cyclin D1 in systemic light-chain amyloidosis. Clin Lymphoma Myeloma Leuk. 2012 Feb;12(1):49-58. doi: 10.1016/j.clml.2011.09.217. Epub 2011 Nov 18.
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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.
Raymond Comenzo, MD principal investigator
Tufts 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 Amyloidosis and Primary Amyloidosis, run by Tufts 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 1 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: finished, as of the sponsor's last update on 24 Aug 2020. 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?
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?
Minimal Residual Disease Testing by Q-PCR, NGS, and mass spectrometry (time frame: 3 years). 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 NCT02555969, which also lists 15 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 24 Aug 2020.