- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07823959
CBC-Based Inflammatory Indices in Newly Diagnosed Multiple Myeloma
Association of CBC-Based Inflammatory Indices With Clinical, Laboratory, and Immunophenotypic Characteristics of Newly Diagnosed Multiple Myeloma
Multiple myeloma is a type of blood cancer characterized by the abnormal growth of plasma cells in the bone marrow. Increasing evidence indicates that interactions between myeloma cells and the host immune-inflammatory response influence disease behavior and patient outcomes. Inflammatory markers calculated from routine complete blood count (CBC) tests, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and monocyte-to-lymphocyte ratio (MLR), offer simple, inexpensive ways to assess systemic inflammation. However, how these markers correlate with baseline clinical presentation, laboratory disease burden, and tumor cell immunophenotypes remains insufficiently explored.
The primary purpose of this cross-sectional study is to evaluate the association between CBC-based inflammatory indices and clinical and laboratory measures of disease severity in patients with newly diagnosed multiple myeloma prior to the start of anti-myeloma therapy. The study will also examine the relationship between these inflammatory indices and the specific immunophenotypic characteristics of neoplastic plasma cells identified via bone marrow flow cytometry.
A total of 60 patients with newly diagnosed multiple myeloma presenting to Assiut University Hospital and the South Egypt Cancer Institute will be enrolled. Baseline demographic and clinical data (including CRAB manifestations and ISS/R-ISS staging), routine blood laboratory results (including albumin, beta-2 microglobulin, and LDH), bone marrow plasma cell percentages, and flow cytometric findings will be collected and analyzed.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Newly diagnosed Multiple Myeloma patients, evaluated prior to the initiation of anti-myeloma therapy
- Both sexes, with no age restriction
Exclusion Criteria:
- Prior receipt of anti-myeloma treatment
- Concurrent active malignancies or other hematological disorders
- Presence of acute or chronic inflammatory or infectious conditions that may influence systemic inflammatory indices
- Concomitant use of medications that significantly alter inflammatory or hematological parameters
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Newly Diagnosed Multiple Myeloma Patients
Patients with newly diagnosed Multiple Myeloma evaluated prior to the initiation of anti-myeloma therapy.
Baseline evaluation includes clinical assessment (demographics, CRAB features, and ISS/R-ISS staging), routine laboratory testing (serum albumin, beta-2 microglobulin, LDH, serum calcium, and renal function tests), complete blood count (CBC) to calculate inflammatory indices (NLR, LMR, PLR, SII, SIRI, PIV, HALP, and CAR), and bone marrow examination (morphological plasma cell percentage and multiparametric flow cytometry for immunophenotypic profiling of neoplastic plasma cells).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Bone Marrow Plasma Cell Percentage
Tidsramme: Baseline
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The percentage of clonal plasma cells quantified on bone marrow aspirate/biopsy smears at diagnosis.
This parameter serves as the primary objective measure of tumor burden and disease severity to evaluate its relationship with baseline complete blood count (CBC)-derived inflammatory indices (specifically the neutrophil-to-lymphocyte ratio [NLR]).
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Baseline
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Hematologiske sykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, plasmacelle
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Hemoragiske lidelser
- Hemic og lymfatiske sykdommer
- Multippelt myelom
Andre studie-ID-numre
- CBC Inflammatory Indices in MM
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