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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

18 Years
Open (Enrolling)
Multiple Myeloma

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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:


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:


Principal Investigator

Beverly Harrison, BS

Investigator Role:

Study Director

Investigator Affiliation:

Multiple Myeloma Research Foundation


United States: Institutional Review Board

Study ID:




Start Date:

July 2011

Completion Date:

July 2019

Related Keywords:

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



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