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

Tracking Information

First Received Date ^ICMJE

June 11, 2009

Last Updated Date

January 3, 2013

Start Date ^ICMJE

November 2003

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Maintainence and expansion of tissue repositories of myeloma specimens from uniformly treated SWOG patients with multiple myeloma, smoldering myeloma, Waldenstrom's macroglobulinema, amyloidosis, or monoclonal gammopathy of undetermined significance [ 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 [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00919139 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

S0309, Myeloma Specimen Repository Protocol, Ancillary

Brief Summary

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.

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

bone marrow and peripheral blood

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Precancerous Condition

Intervention ^ICMJE

Other: biologic sample preservation procedure

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

190

Completion Date

November 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00919139

Other Study ID Numbers ^ICMJE

CDR0000328270, S0309, U10CA032102

Has Data Monitoring Committee

Responsible Party

Southwest Oncology Group

Study Sponsor ^ICMJE

Southwest Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Joshua Espstein, DSC

University of Arkansas

Information Provided By

Southwest Oncology Group

Verification Date

January 2013

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

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