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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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00900263
First received: May 9, 2009
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Multiple Myeloma
Plasma Cell Myeloma
Precancerous Condition
 Genetic: cytogenetic analysis
Genetic: microarray analysis
Other: biologic sample preservation procedure
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Disease progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Bone marrow/peripheral blood


Estimated Enrollment: 350
Study Start Date: June 2002
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

plasmaproliferative disease not requiring therapy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900263

  Show 69 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Madhav Dhodapkar, MD Rockefeller University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00900263     History of Changes
Other Study ID Numbers: CDR0000271421, S0120, U10CA032102
Study First Received: May 9, 2009
Last Updated: January 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage I multiple myeloma
isolated plasmacytoma of bone
monoclonal gammopathy of undetermined significance

Additional relevant MeSH terms:
Monoclonal Gammopathy of Undetermined Significance
Paraproteinemias
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Precancerous Conditions
Hypergammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 19, 2013