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Protocol to Obtain Blood and Bone Marrow Samples for Myeloma Research

This study has been terminated.
(Unable to fill cohort)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01382615
First Posted: June 27, 2011
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  Purpose
The purpose of this study is to collect a blood or bone marrow sample from patients with multiple myeloma and from volunteers without myeloma.

Condition
Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Immune Parameters and Function in Multiple Myeloma Patients and Healthy Individuals' Blood and Marrow Samples

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Cancer cell response to molecular testing of killing cell parts. [ Time Frame: 2 Years ]
    This myeloma specific killing may help identify mechanisms, in vitro, of killing myeloma cells for the future use in clinical trials.


Biospecimen Retention:   Samples With DNA
15mL of peripheral blood 10mL of bone marrow aspirate

Estimated Enrollment: 75
Study Start Date: August 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy Volunteers
Healthy volunteers who have agreed to have a bone marrow and/or blood harvest as part of a donation to a transplant recipient.
Patients with multiple myeloma
Patients undergoing routine blood draw and bone marrow aspirates as part of their ongoing follow-up care for myeloma at the Norris Cotton Cancer Center of DHMC.

Detailed Description:
The blood and bone marrow samples will be used in the laboratory to perform focused studies on multiple myeloma.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center
Criteria

Inclusion Criteria:

  • Participant population is multiple myeloma patients over the age of 18 who are undergoing a scheduled bone marrow collection and/or blood drawing procedure as part of their routine treatment or follow up, and healthy volunteers over the age of 18 who have agreed to have a bone marrow and/or blood harvest as part of a donation to a transplant recipient.

Exclusion Criteria:

  • Patients, who in the opinion of their physician, would be adversely affected by removal of an extra15ml of blood and /or an extra 10ml of bone marrow.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382615


Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Kenneth Meehan, MD Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01382615     History of Changes
Other Study ID Numbers: D1029
First Submitted: April 12, 2010
First Posted: June 27, 2011
Last Update Posted: May 24, 2016
Last Verified: May 2016

Keywords provided by Dartmouth-Hitchcock Medical Center:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases