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NCT01454297Completed

Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile

A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Regimens and Molecular Profiles

Source: ClinicalTrials.gov · Last updated 3 Jan 2024

Brief summary (registry, in English)

The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease.

Status (registry)
Completed
Study type
Observational
Enrollment
1154 (actual)
First submitted
7 Oct 2011
Start date
Jul 2011
Primary completion date
Nov 2023
Lead sponsor
Multiple Myeloma Research Foundation
NCT number
NCT01454297

What you commit to

  • Study type: Observational
  • Participants enrolled: 1154
  • From Jul 2011 to the primary completion date, Nov 2023
  • 73 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient is already receiving systemic therapy for MM (a single dose of bisphosphonates and up to 100 mg total dose of dexamethasone or equivalent corticosteroids are permitted prior to registration on study).

Other illness

  • Patient had another malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).

Other

  • Patient is enrolled in a blinded clinical trial for the first-line treatment of multiple myeloma. Patients may be enrolled in subsequent clinical trials as long as continued access to data and tissue, as per this protocol, is not prohibited.

Who the study is looking for

  • Patient is at least 18 years old.
  • Patient has been diagnosed with symptomatic MM with measurable disease that includes at least one of the following:
    • Serum M protein ≥ 1g/dl Urine M protein ≥ 200 mg/24 hrs Involved free light chain level ≥ 10 mg/dl and an abnormal serum free light chain ratio (\<0.26 or \>1.65).
  • The patient is a candidate for systemic therapy that includes an IMiD® (e.g., lenalidomide, pomalidomide, thalidomide) and/or proteasome inhibitor (e.g., bortezomib, carfilzomib) as part of the initial regimen.
  • No more than 30 days from baseline bone marrow evaluation as per this protocol to initiation of first-line therapy.
  • Patient has read, understood and signed informed consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (73)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tom Baker Cancer Centre, Alberta Health Services
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CalgaryCanadaUnknown status
Cross Cancer Institute, Alberta Health Services
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EdmontonCanadaUnknown status
McGill University Health Center - Royal Victoria Hospital
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MontrealCanadaUnknown status
Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
H. U. Germans Trias i Pujol
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BadalonaSpainUnknown status
Hospital del Mar
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BarcelonaSpainUnknown status
Hospital Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital Clinic i Provincial
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BarcelonaSpainUnknown status
Hospital Ramón y Cajal
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MadridSpainUnknown status
Hospital Puerta de Hierro
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MadridSpainUnknown status
Hospital Son Llàtze
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Palma de MallorcaSpainUnknown status
Hospital Univ Son Espases
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Palma de MallorcaSpainUnknown status
Clinica Universitaria de Navarra
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PamplonaSpainUnknown status
Hospital Quiron de Madrid
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Pozuelo de AlarcónSpainUnknown status
Hospital University de Salamanca
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SalamancaSpainUnknown status
University Hospital Infanta Sofia
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San Sebastián de los ReyesSpainUnknown status
Hospital Universitari de Canarias
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Santa Cruz de TenerifeSpainUnknown status
Hospital Clinica Universitari Lozano Blesa
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ZaragozaSpainUnknown status
Winship Cancer Institute, Emory University
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AtlantaUnited StatesUnknown status
Billings Clinic
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BillingsUnited StatesUnknown status
Waverly Hematology Oncology
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CaryUnited StatesUnknown status
Levine Cancer Institute
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CharlotteUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Ohio State University Wexner Medical Center
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ColumbusUnited StatesUnknown status
Baylor Research Institute
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DallasUnited StatesUnknown status
University of Texas Southwest Medical Center
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DallasUnited StatesUnknown status
Atlanta VA Medical Center
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DecaturUnited StatesUnknown status
Rocky Mountain Cancer Centers
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DenverUnited StatesUnknown status
Kaiser Permanente of Colorado
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DenverUnited StatesUnknown status
Barbara Ann Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Duke University Hospital
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DurhamUnited StatesUnknown status
Virginia Cancer Specialists PV
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FairfaxUnited StatesUnknown status
Grand Rapids Clinical Oncology Program
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Grand RapidsUnited StatesUnknown status
East Carolina University
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GreenvilleUnited StatesUnknown status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Broome Oncology
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Johnson CityUnited StatesUnknown status
Kansas City VA Medical Center
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Kansas CityUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
Saint Barnabas Medical Center
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LivingstonUnited StatesUnknown status
Marshfield Clinic
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MarshfieldUnited StatesUnknown status
Sarah Cannon Research Institute
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NashvilleUnited StatesUnknown status
New York University Medical Center
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Mt Sinai Medical Center
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New YorkUnited StatesUnknown status
Weill Cornell Medical College-NY Presbyterian Hospital
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New YorkUnited StatesUnknown status
Illinois Cancer Specialists
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NilesUnited StatesUnknown status
Ocala Oncology Center
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OcalaUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
First Health Outpatient Cancer Center
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PinehurstUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
St. Francis Hospital
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RoslynUnited StatesUnknown status
Peninsula Regional Cancer Center
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SalisburyUnited StatesUnknown status
Cancer Care Centers of South Texas
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San AntonioUnited StatesUnknown status
Sharp Health Care
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San DiegoUnited StatesUnknown status
VA San Diego Healthcare System
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San DiegoUnited StatesUnknown status
UC San Diego Moores Cancer Center
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San DiegoUnited StatesUnknown status
UCSF Medical Center
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San FranciscoUnited StatesUnknown status
San Francisco VA Medical Center
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San FranciscoUnited StatesUnknown status
Mayo Clinic Campus in Scottsdale, AZ
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ScottsdaleUnited StatesUnknown status
Holy Cross Hospital
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Silver SpringUnited StatesUnknown status
Cancer Care Northwest
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SpokaneUnited StatesUnknown status
Carl and Dorothy Bennett Cancer Center
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StamfordUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
Central Texas VA Healthcare Center
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TempleUnited StatesUnknown status
Eastchester Center for Cancer Care
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The BronxUnited StatesUnknown status
Northwest Cancer Specialists, PC
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TualatinUnited StatesUnknown status
Texas Oncology - Tyler
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TylerUnited StatesUnknown status
Texas Oncology-Waco
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WacoUnited StatesUnknown status
VA Medical Center, Washington DC,
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Washington D.C.United StatesUnknown status
Cancer Center of Kansas
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WichitaUnited StatesUnknown status
Yakima Valley Memorial Hospital/ North Star Lodge
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YakimaUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.