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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 InstituteDetroit, Michigan  48201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Hackensack University Medical CenterHackensack, New Jersey  07601
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Ocala Oncology CenterOcala, Florida  34474
Rocky Mountain Cancer CentersThornton, Colorado  80260
Atlanta Cancer CareAtlanta, Georgia  30342
Cancer Care NorthwestSpokane, Washington  99202
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of ChicagoChicago, Illinois  60637
Washington UniversitySt. Louis, Missouri  63110
Carl and Dorothy Bennett Cancer CenterStamford, Connecticut  06902-3628
Gabrail Cancer CenterCanton, Ohio  44718
Baylor Research InstituteDallas, Texas  75246
Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Eastchester Center for Cancer CareBronx, New York  10469
Oregon Health and Science UniversityPortland, Oregon  97201
Sharp Health CareSan Diego, California  92123
Broome OncologyJohnson City, New York  13790
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Billings ClinicBillings, Montana  59107-7000
Cancer Center of KansasWichita, Kansas  67214
Sarah Cannon Research InstituteNashville, Tennessee  37203
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington  98902
East Carolina UniversityGreenville, North Carolina  27858
Waverly Hematology OncologyCary, North Carolina  27518
Northwest Cancer Specialists, PCPortland, Oregon  97225
Winship Cancer Institute - Emory UniversityAtlanta, Georgia  30322
Mayo Clinic-RochesterRochester, Minnesota  55905
Texas Oncology - TylerTyler, Texas  75702
Maimonides Cancer CenterBrooklyn, New York  11220
UCSF Medical CenterSan Francisco, California  94121
Hutchinson ClinicHutchinson, Kansas  67502
Providence St. Mary Regional Cancer CenterWalla Walla, Washington  99362
Illinois Cancer SpecialistsNiles, Illinois  60714
Texas Oncology - GarlandGarland, Texas  75042
Keck School of Medicine - University of Southern CaliforniaLos Angeles, California  90033
Bay Area Cancer Research Group LLCPleasant Hill, California  94523
Medical Associates of BrevardMelbourne, Florida  32901
Hematology - Oncology Clinic LLPBaton Rouge, Louisiana  70809
Mt Sinai Medical CenterNew York, New York  10029
Texas Oncology - Forth WorthForth Worth, Texas  76104
Texas Oncology- WacoWaco, Texas  76712
Virginia Cancer Specialists PVFairfax, Virginia  22013
Rockwood Clinic , PSSpokane, Washington  99204
VA Medical Center, Washington DC,Washington DC, District of Columbia  20422
Mayo Clinic-JacksonvilleJacksonville, Florida  32224
VA Medical Center, East Orange, NJEast Orange, New Jersey  07018
Weill Cornell Medical College-NY Presbyterian HospitalNew York City, New York  10065
Randolph Cancer CenterAsheboro, North Carolina  27203