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S0309, Repository: Blood/Bone Marrow From Pts. With Myeloma, WM, Amyloidosis, or MGUS.

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: April 1, 2015
Last verified: April 2015
  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
Multiple Myeloma
Smoldering Myeloma
Waldenstrom's Macroglobulinemia
Monoclonal Gammopathy of Undetermined Significance
Amyloidosis
Other: biologic sample preservation procedure

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

Resource links provided by NLM:


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)
Intervention Details:
    Other: biologic sample preservation procedure
    Blood and 3-4 cc bone marrow aspirate collected at same time (in association with treatment protocols on which patient is registered)
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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00919139     History of Changes
Other Study ID Numbers: S0309  S0309  U10CA032102 
Study First Received: June 11, 2009
Last Updated: April 1, 2015
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:
Multiple Myeloma
Neoplasms, Plasma Cell
Waldenstrom Macroglobulinemia
Amyloidosis
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Proteostasis Deficiencies
Metabolic Diseases
Hypergammaglobulinemia

ClinicalTrials.gov processed this record on September 27, 2016