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

Completed

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01454297

Run by

Multiple Myeloma Research Foundation

People needed

1154

Starts

2011-07-01

Expected to finish

2023-12-31

Last updated by the study team

2024-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• UC San Diego Moores Cancer Center — San Diego, California, United States
• Sharp Health Care — San Diego, California, United States
• VA San Diego Healthcare System — San Diego, California, United States
• San Francisco VA Medical Center — San Francisco, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Kaiser Permanente of Colorado — Denver, Colorado, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Carl and Dorothy Bennett Cancer Center — Stamford, Connecticut, United States
• VA Medical Center, Washington DC, — Washington D.C., District of Columbia, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Winship Cancer Institute - Emory University — Atlanta, Georgia, United States
• Atlanta VA Medical Center — Decatur, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Illinois Cancer Specialists — Niles, Illinois, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Peninsula Regional Cancer Center — Salisbury, Maryland, United States
• Holy Cross Hospital — Silver Spring, Maryland, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Grand Rapids Clinical Oncology Program — Grand Rapids, Michigan, United States
• Mayo Clinic-Rochester — Rochester, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Kansas City VA Medical Center — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Billings Clinic — Billings, Montana, United States
• Mayo Clinic Campus in Scottsdale, AZ — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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