- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01746030
Geriatric Assessments in Senior Adults With Multiple Myeloma
Pilot Study of Geriatric Assessments in Senior Adults With Multiple Myeloma
This study will evaluate the prevalence of geriatric syndromes in older adults with multiple myeloma, examine relationships between baseline geriatrics syndromes and initial treatment selection, and examine risk of functional decline.
Relationship between baseline geriatric questionnaires and initial treatment selection in older adults with newly diagnosed multiple myeloma.
Feasibility of subjects completing the CARG geriatric assessments at baseline, 3 months and 6 months.
Comorbidities or dependence in IADLs at baseline predict decline in functional status at 6 months of follow-up in older adults with newly diagnosed multiple myeloma.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Missouri
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St. Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patient must have a diagnosis of multiple myeloma by IMWF criteria: diagnosis must have occurred within 3 months of study enrollment.
- Patient must be ≥ 65 years of age.
- Patient's life expectancy must be ≥ 6 months.
- Patient must be willing to complete follow-up assessments.
- Patient must be able to understand and willing to sign a written informed consent document.
Exclusion Criteria:
- Patient must not have a diagnosis of smoldering myeloma.
- Patient must not have concomitant amyloidosis.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Questionnaires
No treatment
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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The relationship between initial treatment recommendation and baseline questionnaires assessment
Tidsramme: At baseline visit
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The physician caring for the patient will be asked to identify his/her initial treatment recommendations.
This includes whether the patient is, in his/her assessment, a candidate for high dose therapy and autologous stem cell transplantation.
It will also include whether a 2-drug or 3-drug regimen is recommended initially.
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At baseline visit
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes in questionnaires from baseline to 6 months
Tidsramme: Through 6 months of follow-up
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Logistic regression analyses, adjusted odds ratios (ORs) based on model will be given with 95% CIs.
All analyses will use two-tailed significance levels of 0.05 and will be conducted with statistical software SAS 9.2.
Geriatric assessment variables will be analyzed as continuous or ordinal variables as indicated.
Candidate variables will include: demographic data (including age, gender, race), disease data (stage, cytogenetic abnormalities), or geriatric assessment variables (comorbidity, functional status, physical function, psychological state, nutrition, social support and social activity).
Analyses will be performed for the outcomes of treatment selection (transplant vs non-transplant) and increased dependence in IADLs
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Through 6 months of follow-up
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Completion of the questionnaires at baseline, 3 months and 6 months.
Tidsramme: Baseline, 3 months, and 6 months
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Feasibility of subjects completing questionnaires is defined as 90% of consenting subjects completing the baseline geriatric assessment battery, and 80% of consenting subjects completing follow-up assessments at 3 and 6 months.
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Baseline, 3 months, and 6 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Tanya Wildes, M.D., Washington University School of Medicine
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hematologiske sykdommer
- Hemoragiske lidelser
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Multippelt myelom
- Neoplasmer, plasmacelle
Andre studie-ID-numre
- 201207060
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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National Cancer Institute (NCI)FullførtMyelom-multippel | Myelom, plasmacelleForente stater
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Tel-Aviv Sourasky Medical CenterFullførtPlasmacellemyelom | Myelom-multippel | Myelom multippel | Myelom, plasmacelleIsrael
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US Oncology ResearchKaryopharm Therapeutics IncRekrutteringMultippelt myelom | Plasmacellemyelom | Myelom-multippel | Myelom multippel | Kahlers sykdom | Myelom, plasmacelle | MyelomatoseForente stater
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Mayo ClinicFullførtMultippelt myelom | Stage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater
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University of ChicagoNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater, Canada
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Sidney Kimmel Cancer Center at Thomas Jefferson...FullførtStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater