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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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

Details

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.

Keywords

Multiple Myeloma Myeloma Observational Longitudinal Neoplasms, Plasma Cell

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • San Francisco VA Medical Center
    San Francisco, California, 94121, United States
  • UCSF Medical Center
    San Francisco, California, 94143, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Multiple Myeloma Research Foundation
Links
The Multiple Myeloma Research Foundation
ID
NCT01454297
Lead Scientist
Study Type
Observational
Last Updated
September 2016