Clinical trial · Observational
S0120, Studying Blood and Bone Marrow Samples From Patients With Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, or Plasmacytoma
S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders
NCT00900263CI-TRIAL-00024187completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma may help doctors learn more about changes that occur in DNA and identify biomarkers related to these diseases. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is looking at blood and bone marrow samples from patients with monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Plasma Cell Myeloma | Multiple Myeloma | CURATED_BROADER | 0.80 |
| Precancerous Condition | Monoclonal Gammopathy of Undetermined Significance | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biologic sample preservation procedure | Other | — | UNRESOLVED |
| cytogenetic analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| microarray analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease progression
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of one of the following plasmaproliferative diseases: * Monoclonal gammopathy of undetermined significance (MGUS) * Asymptomatic multiple myeloma * Solitary plasmacytoma * Other plasma cell dyscrasias * Disease does not require therapy * Willing to submit research samples for gene expression analysis and immunologic assessment PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No other malignancy within the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy for this disease Chemotherapy * No prior chemotherapy for this disease Endocrine therapy * No prior endocrine therapy for this disease Radiotherapy * No prior radiotherapy for this disease Surgery * No prior surgery for this disease Other * Prior or concurrent bisphosphonates allowed
References
Publications (5)
- BACKGROUNDSpisek R, Kukreja A, Chen LC, Matthews P, Mazumder A, Vesole D, Jagannath S, Zebroski HA, Simpson AJ, Ritter G, Durie B, Crowley J, Shaughnessy JD Jr, Scanlan MJ, Gure AO, Barlogie B, Dhodapkar MV. Frequent and specific immunity to the embryonal stem cell-associated antigen SOX2 in patients with monoclonal gammopathy. J Exp Med. 2007 Apr 16;204(4):831-40. doi: 10.1084/jem.20062387. Epub 2007 Mar 26. PMID 17389240
- BACKGROUNDZhan F, Barlogie B, Arzoumanian V, Huang Y, Williams DR, Hollmig K, Pineda-Roman M, Tricot G, van Rhee F, Zangari M, Dhodapkar M, Shaughnessy JD Jr. Gene-expression signature of benign monoclonal gammopathy evident in multiple myeloma is linked to good prognosis. Blood. 2007 Feb 15;109(4):1692-700. doi: 10.1182/blood-2006-07-037077. Epub 2006 Oct 5. PMID 17023574
- DERIVEDDhodapkar MV, Sexton R, Hoering A, Van Rhee F, Barlogie B, Orlowski R. Race-Dependent Differences in Risk, Genomics, and Epstein-Barr Virus Exposure in Monoclonal Gammopathies: Results of SWOG S0120. Clin Cancer Res. 2020 Nov 15;26(22):5814-5819. doi: 10.1158/1078-0432.CCR-20-2119. Epub 2020 Aug 18. PMID 32816893
- DERIVEDDhodapkar MV, Sexton R, Das R, Dhodapkar KM, Zhang L, Sundaram R, Soni S, Crowley JJ, Orlowski RZ, Barlogie B. Prospective analysis of antigen-specific immunity, stem-cell antigens, and immune checkpoints in monoclonal gammopathy. Blood. 2015 Nov 26;126(22):2475-8. doi: 10.1182/blood-2015-03-632919. Epub 2015 Oct 14. PMID 26468228
- DERIVEDDhodapkar MV, Sexton R, Waheed S, Usmani S, Papanikolaou X, Nair B, Petty N, Shaughnessy JD Jr, Hoering A, Crowley J, Orlowski RZ, Barlogie B. Clinical, genomic, and imaging predictors of myeloma progression from asymptomatic monoclonal gammopathies (SWOG S0120). Blood. 2014 Jan 2;123(1):78-85. doi: 10.1182/blood-2013-07-515239. Epub 2013 Oct 21. PMID 24144643