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

Multiple Myeloma Clinical Trial

— CoMMpass  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454297
• Other study ID #: MMRF-11-001
• Status: Completed
• Start date: July 2011
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Multiple Myeloma Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Understanding the molecular basis of cancer is a critical step toward devising the most effective treatment of the patient as an individual. The promise of molecular targeted therapeutics and personalized cancer care has been demonstrated in breast and lung cancer and chronic myeloid leukemia. However, similar examples of success in multiple myeloma have not been achieved despite extensive basic research as well as clinical advances. What is well understood is that myeloma is a heterogeneous disease with great genetic and epigenetic complexity.22, 23 Therefore, there remains a critical need to understand myeloma patient biology in the context of current patient care.24 The objective of this longitudinal study is to identify patient subgroups and phenotypes defined by molecular profiling and clinical features. These profiles will enable a better understanding of mechanisms of disease, drug response and patient relapse. Ultimately the study is intended to drive successful drug development and patient care in multiple myeloma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1154
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre, Alberta Health Services	Calgary	Alberta
Canada	Cross Cancer Institute, Alberta Health Services	Edmonton	Alberta
Canada	McGill University Health Center, Royal Victoria Hospital	Montreal	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Spain	H. U. Germans Trias i Pujol	Badalona	Cataluña
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Santa Creu I Sant Pau	Barcelona
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Son Llàtze	Palma de Mallorca	Islas Baleares
Spain	Hospital Univ Son Espases	Palma de Mallorca	Islas Baleares
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital Quirón de Madrid	Pozuelo de Alarcón	Madrid
Spain	Hospital University de Salamanca	Salamanca	Castilla-León
Spain	University Hospital Infanta Sofia	San Sebastián de los Reyes	Madrid
Spain	Hospital Universitari de Canarias	Tenerife	Santa Cruz
Spain	Hospital Clinica Universitari Lozano Blesa	Zaragoza	Aragón
United States	Winship Cancer Institute - Emory University	Atlanta	Georgia
United States	Billings Clinic	Billings	Montana
United States	Eastchester Center for Cancer Care	Bronx	New York
United States	Waverly Hematology Oncology	Cary	North Carolina
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	University of Texas Southwest Medical Center	Dallas	Texas
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	Kaiser Permanente of Colorado	Denver	Colorado
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Duke University Hospital	Durham	North Carolina
United States	Virginia Cancer Specialists PV	Fairfax	Virginia
United States	Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	East Carolina University	Greenville	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Broome Oncology	Johnson City	New York
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Mt Sinai Medical Center	New York	New York
United States	New York University Medical Center	New York	New York
United States	Weill Cornell Medical College-NY Presbyterian Hospital	New York	New York
United States	Illinois Cancer Specialists	Niles	Illinois
United States	Ocala Oncology Center	Ocala	Florida
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	First Health Outpatient Cancer Center	Pinehurst	North Carolina
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic-Rochester	Rochester	Minnesota
United States	St Francis Hospital	Roslyn	New York
United States	Washington University	Saint Louis	Missouri
United States	Peninsula Regional Cancer Center	Salisbury	Maryland
United States	Cancer Care Centers of South Texas	San Antonio	Texas
United States	Sharp Health Care	San Diego	California
United States	UC San Diego Moores Cancer Center	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	Mayo Clinic Campus in Scottsdale, AZ	Scottsdale	Arizona
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	Cancer Care Northwest	Spokane	Washington
United States	Carl and Dorothy Bennett Cancer Center	Stamford	Connecticut
United States	Central Texas VA Healthcare Center	Temple	Texas
United States	Northwest Cancer Specialists, PC	Tualatin	Oregon
United States	Texas Oncology - Tyler	Tyler	Texas
United States	Texas Oncology- Waco	Waco	Texas
United States	VA Medical Center, Washington DC,	Washington	District of Columbia
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Yakima Valley Memorial Hospital/North Star Lodge	Yakima	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Multiple Myeloma Research Foundation	Spectrum Health Hospitals, Translational Genomics Research Institute, Van Andel Research Institute

Countries where clinical trial is conducted

United States,  Canada,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease.	Standard clinical and laboratory assessments. Genomic tests (DNA and RNA sequencing, etc.) on bone marrow aspirates obtained at baseline, suspected complete response, and relapse/progression.	Baseline to 8 years.
Secondary	Response rates	IMWG criteria: stringent complete response, complete response, very good partial response, partial response, no response.	Up to one year after baseline.
Secondary	Survival rates	Progression-free survival and overall survival	Five to eight years after baseline
Secondary	Bone disease assessed radiographically		Baseline and during five to eight years of follow-up
Secondary	Health-related quality of life	EORTC QLQ-C30 and QLQ-MY20	Baseline and during five to eight years of follow-up
Secondary	Resource utilization	Hospitalizations and ER visits	Baseline and during five to eight years of follow-up
Secondary	Severe adverse events	Severe/CTCAE grade 3-4 adverse events (checklist)	Five to eight years

External Links

•   The Multiple Myeloma Research Foundation