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


N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease.

Outcome Description:

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.

Outcome Time Frame:

Baseline to 5years.

Safety Issue:

No

Principal Investigator

Beverly Harrison, BS

Investigator Role:

Study Director

Investigator Affiliation:

Multiple Myeloma Research Foundation

Authority:

United States: Institutional Review Board

Study ID:

MMRF-11-001

NCT ID:

NCT01454297

Start Date:

July 2011

Completion Date:

July 2019

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Multiple Myeloma
  • Observational
  • Longitudinal
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Hackensack University Medical Center Hackensack, New Jersey  07601
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
Ocala Oncology Center Ocala, Florida  34474
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Atlanta Cancer Care Atlanta, Georgia  30342
Cancer Care Northwest Spokane, Washington  99202
Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Chicago Chicago, Illinois  60637
Washington University St. Louis, Missouri  63110
Carl and Dorothy Bennett Cancer Center Stamford, Connecticut  06902-3628
Gabrail Cancer Center Canton, Ohio  44718
Baylor Research Institute Dallas, Texas  75246
Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
Eastchester Center for Cancer Care Bronx, New York  10469
Oregon Health and Science University Portland, Oregon  97201
Sharp Health Care San Diego, California  92123
Broome Oncology Johnson City, New York  13790
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Billings Clinic Billings, Montana  59107-7000
Cancer Center of Kansas Wichita, Kansas  67214
Sarah Cannon Research Institute Nashville, Tennessee  37203
Cancer Care Centers of South Texas San Antonio, Texas  78229
Yakima Valley Memorial Hospital/North Star Lodge Yakima, Washington  98902
East Carolina University Greenville, North Carolina  27858
Waverly Hematology Oncology Cary, North Carolina  27518
Northwest Cancer Specialists, PC Portland, Oregon  97225
Winship Cancer Institute - Emory University Atlanta, Georgia  30322
Mayo Clinic-Rochester Rochester, Minnesota  55905
Texas Oncology - Tyler Tyler, Texas  75702
Maimonides Cancer Center Brooklyn, New York  11220
UCSF Medical Center San Francisco, California  94121
Hutchinson Clinic Hutchinson, Kansas  67502
Providence St. Mary Regional Cancer Center Walla Walla, Washington  99362
Illinois Cancer Specialists Niles, Illinois  60714
Texas Oncology - Garland Garland, Texas  75042
Keck School of Medicine - University of Southern California Los Angeles, California  90033
Bay Area Cancer Research Group LLC Pleasant Hill, California  94523
Medical Associates of Brevard Melbourne, Florida  32901
Hematology - Oncology Clinic LLP Baton Rouge, Louisiana  70809
Mt Sinai Medical Center New York, New York  10029
Texas Oncology - Forth Worth Forth Worth, Texas  76104
Texas Oncology- Waco Waco, Texas  76712
Virginia Cancer Specialists PV Fairfax, Virginia  22013
Rockwood Clinic , PS Spokane, Washington  99204
VA Medical Center, Washington DC, Washington DC, District of Columbia  20422
Mayo Clinic-Jacksonville Jacksonville, Florida  32224
VA Medical Center, East Orange, NJ East Orange, New Jersey  07018
Weill Cornell Medical College-NY Presbyterian Hospital New York City, New York  10065
Randolph Cancer Center Asheboro, North Carolina  27203