Text Size

S0309, Collecting and Storing Blood and Bone Marrow Samples From Patients With Myeloma, Waldenstrom's Macroglobulinemia, Amyloidosis, or Monoclonal Gammopathy of Undetermined Significance

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00919139
First received: June 11, 2009
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer to study in the laboratory may help doctors find better ways to ways to treat the cancer.

PURPOSE: The purpose of this study is to collect and store blood and bone marrow samples from patients with multiple myeloma, smoldering myeloma, Waldenstrom's macroglobulinemia, amyloidosis, and monoclonal gammopathy of undetermined significance to be tested in the laboratory.


Condition Intervention
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Precancerous Condition
 Other: biologic sample preservation procedure

Study Type: Observational
Official Title: S0309, Myeloma Specimen Repository Protocol, Ancillary

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Maintenance and expansion of tissue repositories of myeloma specimens from uniformly treated SWOG patients with multiple myeloma, smoldering myeloma, Waldenstrom's macroglobulinemia, amyloidosis, or monoclonal gammopathy of undetermined significance [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Development of new and more effective treatment regimens for these patients using scientific information generated from intergroup and collaborative studies [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

bone marrow and peripheral blood


Enrollment: 190
Study Start Date: November 2003
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Maintain and expand tissue repositories of myeloma specimens from uniformly treated Southwest Oncology Group (SWOG) patients with multiple myeloma, smoldering myeloma, Waldenstrom's macroglobulinemia, amyloidosis, or monoclonal gammopathy of undetermined significance.
  • Utilize scientific information generated from intergroup and collaborative studies to assist the SWOG Myeloma Committee in the development of new and more effective treatment regimens for these patients.

OUTLINE: Patients receive treatment as directed by the treatment protocols on which they are registered. Specimens of blood and/or marrow are submitted to the Myeloma Repository. The status of the patient (e.g., pre-study, post-remission, or relapse) will be recorded prior to specimen collection.

PROJECTED ACCRUAL: Not specified

  Eligibility

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

patients enrolled on MM, SM, WM, amyloid or MGUS treatment/observation studies.

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Multiple myeloma
    • Smoldering myeloma
    • Waldenstrom's macroglobulinemia
    • Amyloidosis
    • Monoclonal gammopathy of undetermined significance
  • Must be currently registered on a Southwest Oncology Group-coordinated treatment study (SWOG or Intergroup)
  • Must have pretreatment specimens to submit to this study
  • No cytogenetic samples

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919139

  Show 207 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Joshua Espstein, DSC University of Arkansas
  More Information

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

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00919139     History of Changes
Other Study ID Numbers: CDR0000328270, S0309, U10CA032102
Study First Received: June 11, 2009
Last Updated: January 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
multiple myeloma
Waldenström macroglobulinemia
monoclonal gammopathy of undetermined significance
primary systemic amyloidosis

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

ClinicalTrials.gov processed this record on June 18, 2013