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Questionnaire and Tissue Banking For Multiple Myeloma, Waldenstrom Macroglobulinemia and Related Disorders

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ClinicalTrials.gov Identifier: NCT01177527
Recruitment Status : Recruiting
First Posted : August 9, 2010
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Irene Ghobrial, MD, Dana-Farber Cancer Institute

August 5, 2010
August 9, 2010
October 16, 2017
December 2009
December 2018   (Final data collection date for primary outcome measure)
  • Databank [ Time Frame: 3 years ]
    To establish a databank of patients with MM, WM, MGUS, sMM, or related disorders. This databank will include medical history data and bone marrow and peripheral blood samples.
  • Unique characteristics [ Time Frame: 3 years ]
    To determine whether patients with MM, WM, MGUS, sMM, or related disorders have unique proteomic, genetic and epigenetic characteristics in the malignant clone or the microenvironment and linking information to the clinical characteristics of the patients through exploratory tests.
Same as current
Complete list of historical versions of study NCT01177527 on ClinicalTrials.gov Archive Site
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Questionnaire and Tissue Banking For Multiple Myeloma, Waldenstrom Macroglobulinemia and Related Disorders
Medical Questionnaire and Tissue Banking For Multiple Myeloma, Waldenstrom Macroglobulinemia and Related Disorders
The purpose of this study is to obtain bone marrow and peripheral blood samples, along with clinical data from patients with Multiple Myeloma (MM), Waldenstrom's Macroglobulinemia (WM), Smoldering MM, and other lymphoplasmacytic lymphomas (LPL) including but not limited to MGUS and IgG or IgA LPL. These samples will become part of a tissue bank and will be used in ongoing studies to find out more about the causes and biology of MM, WM and LPL; to identify what factors result in normal cells becoming cancer; to determine how to improve treatment options; to study how the immune system identifies abnormal cells; and to evaluate the immune function in these diseases. The investigators will also study the tumor cells at the level of the participant's genes to develop treatment strategies as well as to better understand how biologic differences affect patient outcomes.
  • Participants will be asked to complete a medical survey which includes demographics, diagnosis, and treatment history, medical history, lab results and symptoms experienced.
  • Participants will then receive instructions for the tissue banking procedure, which involves donating bone marrow and blood samples. These will be collected only at times when necessary clinical bone marrow samples are obtained and will not require an extra visit to the doctor.
  • The investigators are also requesting permission to collect medical information from the participant's record and link this information to the specimens so that we may better understand the participant's response to treatment. For samples obtained prior to beginning therapy, this information might allow us to develop new ways of predicting response to therapy. The investigators are also requesting permission to store samples of blood and bone marrow to establish a tissue bank for future research to these diseases. These samples will be de-identified; any of the participant's personal health information identifiers will be removed.
  • The tumor sample may be obtained at diagnosis, during treatment and/or as the time of relapse. The timing of sample collection will coincide with other bone marrow tests required to assess the response to therapy or any other clinical purpose.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Peripheral blood Bone marrow samples
Non-Probability Sample

Participant's will be identified through several mechanisms:

  1. Primary recruitment will occur via Internet advertising through patient websites including but not limited to the International Waldenstrom's Macroglobulinemia Foundation (IWMF), the Leukemia and Lymphoma Society and the Multiple Myeloma Research Foundation (MMRF) websites.
  2. Investigators who identify patients at Dana-Farber Cancer Institute (DFCI) who do not wish to continue their treatment plan at DFCI can approach these patients to participate in this study
  • Multiple Myeloma
  • Waldenstrom's Macroglobulinemia
  • Smoldering Multiple Myeloma
  • Lymphoblastic Lymphoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Same as current
December 2020
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any individual diagnosed with Multiple Myeloma, Waldenstrom Macroglobulinemia, MGUS, smoldering MM or other lymphoplasmacytic lymphomas
  • Signed informed consent
  • 18 years of age or older
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Irene Ghobrial, MD 617-632-4198 irene_ghobrial@dfci.harvard.edu
United States
 
 
NCT01177527
09-233
No
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Irene Ghobrial, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Irene Ghobrial, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
October 2017