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dbGaP phs001323 Multiple Myeloma Genomic Study (MMGS) - pht010117.v3.p1

- 3/13/23 - 5 forms, 1 itemgroup, 7 items, 1 language

Itemgroup: pht010117

Principal Investigator: Irene M. Ghobrial, Dana Farber Cancer Institute, Boston, MA, USA MeSH: Multiple Myeloma,Monoclonal Gammopathy of Undetermined Significance https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001323 Multiple Myeloma (MM) is a plasma cell dyscrasia characterized by bone marrow (BM) infiltration and lytic bone lesions. Recent studies of massive parallel sequencing of tumor cells obtained from the BM of patients with MM have demonstrated significant clonal heterogeneity in MM. Despite this remarkable clonal heterogeneity, it could be envisioned that such clonal diversity may be even higher since single BM samples only represent a small fraction of the whole BM compartment, and the pattern of BM infiltration in MM is typically patchy. In addition, BM biopsies are painful and cannot be repeated multiple times during the course of therapy, indicating a need for less invasive methods to molecularly characterize MM patients and monitor disease progression during the therapy. Thus, optimal characterization of circulating tumor cells (CTCs) may represent a non-invasive method to capture relevant mutations present in PC clones. In addition, MM almost always progresses from precursor states of monoclonal gammopathy of undetermined significance (MGUS)/smoldering multiple myeloma (SMM) to overt MM. However, some patients rapidly progress from MGUS/SMM to overt MM (progressors) with a rate of progression of up to 70% over 5 years, while others remain indolent with minimal progression over the same time period (non-progressors). Although many patients are diagnosed with earlier phases of disease, most patients do not receive treatment until their disease progresses, at which time they have overt end-organ damage. This concept of initiating therapy at the time of symptomatic disease is analogous to initiating therapy in patients with solid tumors only after the development of measurable metastatic disease. It is therefore not surprising that cure is not achieved for most patients with MM. Interestingly, studies have demonstrated that MGUS/SMM clones may already harbor chromosomal alterations (Ig loci or hyperdiploidy) and that progression to MM is mainly due to expansion of clones that were already present in the early stages of MGUS/SMM. However, the biological factors that discriminate progressors from non-progressors in MGUS/SMM are not well known. Therefore, our overarching hypothesis is that an effective therapeutic intervention will result from defining genomic and transcriptomic markers that are associated with disease progression. We believe, therefore, that focused research studies that define molecular mechanisms of clonal evolution in MGUS/SMM/MM will identify novel biomarkers of disease progression and help develop therapeutic agents that prevent or delay progression from MGUS to overt MM. Indeed, by eradicating the disease at the precursor stages, MM may become a preventable disease. Recently, a new term called Clonal Hematopoiesis of Indeterminate Potential (CHIP) has been proposed to describe asymptomatic individuals with hematologic malignancy-associated somatic mutations. Those individuals do not fulfill any diagnostic criteria for any hematological malignancy yet they have a tendency to progress into myelodysplastic syndrome (MDS) or myeloid or lymphoid neoplasia at a rate of around 0.5-1% per year, similar to MGUS. The frequency of CHIP and role of HSCs mutations in enhancing acquisition of somatic mutations in MM plasma cells, allowing progression following treatment, has not been studied. Investigating the dysregulated pathways in early progenitor cells would allow us to understand the reasons of progression and establish novel therapeutic and potentially preventive strategies. This study dissects genomic and transcriptomic characteristics of clonal evolution from MGUS/SMM to MM as well as the characteristics of the tumor microenvironment/immune cells/peripheral blood. Our hypothesis is that molecular biomarkers will be strong predictors of progression from MGUS/SMM to MM and will allow for the development of novel therapeutic agents that prevent or delay this progression. We aim to define genomic and transcriptomic markers that lead to progression from MGUS/SMM to MM in tumor cells, blood biopsies (cell free DNA and circulating tumor cells), and the tumor microenvironment.

pht010115.v3.p1

1 itemgroup 2 items

pht010116.v3.p1

1 itemgroup 4 items

Eligibility

1 itemgroup 7 items

pht010114.v3.p1

1 itemgroup 2 items

dbGaP phs000545 Predicting Chemotherapy-Induced Mucositis with Genetic and Clinical Factors - Eligibility

- 12/13/22 - 5 forms, 1 itemgroup, 2 items, 1 language

Itemgroup: IG.elig

Principal Investigator: E. Ann Coleman, University of Arkansas for Medical Sciences Little Rock, Arkansas, USA MeSH: Multiple Myeloma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000545 We hypothesized that genetic variability in the enzymes/proteins involved in drug metabolism, inflammation, and immune function is a major underlying contributor to mucositis incidence and progression and that, based on this variability we can identify variants that influence risk, and develop a mucositis progression prediction model that improves on existing models by incorporating genetic variability along with clinical factors. Using genome wide association study (GWAS) combined with a pathway candidate gene approach and a modified case-control study method, we investigated the hypothesis in a sample of 1092 patients who received a myeloablative dose of melphalan (MEL) followed by autologous hematopoietic stem cell (ASCT) transplantation as treatment for multiple myeloma and for whom banked blood stem cell samples and clinical data were available.

Multiple Myeloma

pht003762.v1.p1

1 itemgroup 2 items

pht003763.v1.p1

1 itemgroup 5 items

pht003764.v1.p1

1 itemgroup 25 items

pht003765.v1.p1

1 itemgroup 5 items

dbGaP phs000748 Multiple Myeloma CoMMpass Study - pht003889.v7.p4

- 12/10/22 - 5 forms, 1 itemgroup, 7 items, 1 language

Itemgroup: pht003889

Principal Investigator: Sagar Lonial, MD, Multiple Myeloma Research Foundation (MMRF), Norwalk, CT and Emory University, Atlanta, GA, USA MeSH: Multiple Myeloma,Neoplasms, Plasma Cell https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000748 The Multiple Myeloma Research Foundation (MMRF) CoMMpass (Relating *C*linical *O*utcomes in *MM* to *P*ersonal *Ass*essment of Genetic Profile) trial (NCT01454297) is a longitudinal observation study of 1000 newly diagnosed myeloma patients receiving various standard approved treatments that aim at collecting tissue samples, genetic information, Quality of Life (QoL) and various disease and clinical outcomes over 10 years.

pht003890.v7.p4

1 itemgroup 12 items

pht003887.v7.p4

1 itemgroup 5 items

pht003888.v7.p4

1 itemgroup 5 items

Eligibility

1 itemgroup 12 items

dbGaP phs000348 Towards a Genomic Understanding of Myeloma - Eligibility

- 10/12/22 - 5 forms, 1 itemgroup, 3 items, 1 language

Itemgroup: IG.elig

Principal Investigator: Todd Golub, Broad Institute of MIT and Harvard Dana Farber Cancer Institute, Boston, MA, USA MeSH: Multiple Myeloma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000348 This project was designed to describe genetic abnormalities in primary samples from patients with multiple myeloma by next generation sequencing. We generated sequence data from multiple myeloma (MM) patients analyzing DNA both from tumor cells (purified from bone marrow using CD138 selection as a marker of plasma cells) and from normal peripheral blood cells (either whole blood or Ficoll-purified mononuclear cells). Using massively parallel sequencing technology (Illumina GA-2 or HiSeq)), we performed whole-genome sequencing (WGS) and/or whole-exome sequencing (WES). The initial set currently deposited contains data from 38 MM patients (23 patients surveyed by WGS and 16 patients by WES, with one patient analyzed by both approaches). Genomes were sampled to high depth, obtaining an average of 33X coverage and 104X coverage for WGS and WES tumors, respectively. The normal samples had similar coverage. Our goal is to help researchers understand the complex genetic landscape of multiple myeloma and provide a resource for the generation of biological hypotheses.

Multiple Myeloma

pht002228.v2.p1

1 itemgroup 2 items

pht002229.v2.p1

1 itemgroup 3 items

pht002230.v2.p1

1 itemgroup 23 items

pht002231.v2.p1

1 itemgroup 4 items

German Myeloma Patient Outcome Scale (MyPOS) - MyPOS

- 3/15/22 - 1 form, 8 itemgroups, 40 items, 1 language

Itemgroups: Administratative Angaben, Symptome und Nebenwirkungen - Beeinträchtigung in der letzten Woche, Beeinträchtigung durch weitere Symptome, Verlauf der letzten Woche (Teil 1), Verlauf der letzten Woche (Teil 2), Probleme und Sorgen, Sorgen und Ängste, Ausfüllen des Fragebogens

Die Nutzung des MyPOS ist kostenfrei, es wird aber eine (kostenfreie) Registrierung auf der POS-Website (www.pos-pal.org) gewünscht. Um eine Information über Nutzung und/oder Änderung wird seitens des POS-Team explizit gebeten. Affiliation: Dr. med. Christina Gerlach M.Sc. Oberärztin | Klinik für Palliativmedizin Fachärztin für Innere Medizin, Hämatologie & Onkologie; Notfallmedizin, Palliativmedizin Universitätsklinikum Heidelberg | Im Neuenheimer Feld 305 | 69120 Heidelberg Tel. +49 6221 56-310683 | Fax. +49 6221 56-7203 | E-Mail: christina.gerlach@med.uni-heidelberg.de http://www.klinikum.uni-heidelberg.de Gerlach, C., Taylor, K., Ferner, M. et al. Challenges in the cultural adaptation of the German Myeloma Patient Outcome Scale (MyPOS): an outcome measure to support routine symptom assessment in myeloma care. BMC Cancer 20, 245 (2020). https://doi.org/10.1186/s12885-020-06730-7

Eligibility Multiple Myeloma NCT01432353

- 9/22/21 - 1 form, 2 itemgroups, 15 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01432353

Eligibility Thrombocytopenia NCT01484314

- 9/22/21 - 1 form, 2 itemgroups, 11 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01484314

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Screening - Demography; Inclusion Criteria; Exclusion Criteria

- 9/20/21 - 1 form, 4 itemgroups, 34 items, 1 language

Itemgroups: Administrative, Demography, Inclusion Criteria, Exclusion Criteria

Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Eligibility DRKS00003823 NCT00478777 Relapsed or Refractory Multiple Myeloma - Eligibility

- 9/20/21 - 1 form, 2 itemgroups, 27 items, 2 languages

Itemgroups: Inclusion Criteria, Exclusion Criteria

ODM derived from http://clinicaltrials.gov/show/NCT00478777

Eligibility Multiple Myeloma NCT00642395

- 9/20/21 - 1 form, 2 itemgroups, 21 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT); ODM derived from: https://clinicaltrials.gov/show/NCT00642395

Eligibility Multiple Myeloma NCT00590603

- 9/20/21 - 1 form, 2 itemgroups, 11 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Trisenox, Ascorbic Acid and Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00590603

Multiple Myeloma Lenalidomide Melphalan NCT01090089 - Eligibility

- 9/20/21 - 1 form, 2 itemgroups, 50 items, 2 languages

Itemgroups: Inclusion Criteria, Exclusion Criteria

ODM derived from http://clinicaltrials.gov/show/NCT01090089 The Combination of Lenalidomide and Dexamethasone With or Without Intensification by High-dose Melphalan in the Treatment of Multiple Myeloma

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