Clinical trial NCT01177527: Questionnaire and Tissue Banking For Multiple Myeloma, Waldenstrom Macroglobulinemia and Related Disorders
Official title: Medical Questionnaire and Tissue Banking For Multiple Myeloma, Waldenstrom Macroglobulinemia and Related Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Myeloma
Waldenstrom's Macroglobulinemia
Smoldering Multiple Myeloma
Lymphoblastic Lymphoma
Keywords: Waldenstrom
myeloma
smoldering
lymphoma
MGUS
distinct B-cell lymphoproliferative disorder
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2010-08-09
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: * 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.

Eligibility criteria: 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

Primary outcomes:
measure: Databank
timeFrame: 3 years
measure: Unique characteristics
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Irene Ghobrial, MD
role: PRINCIPAL_INVESTIGATOR
References: