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S0120, Studying Blood and Bone Marrow Samples From Patients With Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, or Plasmacytoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00900263
First received: May 9, 2009
Last updated: January 15, 2014
Last verified: January 2014

May 9, 2009
January 15, 2014
June 2002
April 2016   (final data collection date for primary outcome measure)
Disease progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Disease progression [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00900263 on ClinicalTrials.gov Archive Site
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S0120, Studying Blood and Bone Marrow Samples From Patients With Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, or Plasmacytoma
S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders

RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma may help doctors learn more about changes that occur in DNA and identify biomarkers related to these diseases. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood and bone marrow samples from patients with monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma.

OBJECTIVES:

  • Establish a serum, cell, and bone marrow tissue bank of prospectively collected samples from patients with monoclonal gammopathy of undetermined significance (MGUS), asymptomatic multiple myeloma, solitary plasmacytoma, or other plasma cell dyscrasias.
  • Evaluate the feasibility of accruing patients with these diseases.
  • Determine whether patterns of gene expression or cytogenetics exist that allow molecular delineation of MGUS subtypes.
  • Characterize cellular and humoral immune response to known tumor antigens in these patients.
  • Cryopreserve serum/T cells for future evaluation.
  • Preliminarily identify biological correlates that may relate to progression to symptomatic disease.

OUTLINE: Patients are stratified according to diagnosis (monoclonal gammopathy of undetermined significance [MGUS] or other plasma cell dyscrasias vs asymptomatic multiple myeloma vs solitary plasmacytoma).

Blood and bone marrow samples are collected and analyzed for microarray analysis, cytogenetic analysis, and immunobiology studies.

Unused samples may be stored for future research studies.

Patients are followed periodically for 5 years.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Bone marrow/peripheral blood

Non-Probability Sample

plasmaproliferative disease not requiring therapy

  • Multiple Myeloma
  • Plasma Cell Myeloma
  • Precancerous Condition
  • Genetic: cytogenetic analysis
  • Genetic: microarray analysis
  • Other: biologic sample preservation procedure
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
350
Not Provided
April 2016   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following plasmaproliferative diseases:

    • Monoclonal gammopathy of undetermined significance (MGUS)
    • Asymptomatic multiple myeloma
    • Solitary plasmacytoma
    • Other plasma cell dyscrasias
  • Disease does not require therapy
  • Willing to submit research samples for gene expression analysis and immunologic assessment

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No other malignancy within the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for this disease

Chemotherapy

  • No prior chemotherapy for this disease

Endocrine therapy

  • No prior endocrine therapy for this disease

Radiotherapy

  • No prior radiotherapy for this disease

Surgery

  • No prior surgery for this disease

Other

  • Prior or concurrent bisphosphonates allowed
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00900263
CDR0000271421, S0120, U10CA032102
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Madhav Dhodapkar, MD Rockefeller University
Southwest Oncology Group
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP