Protocol to Obtain Blood and Bone Marrow Samples for Myeloma Research

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01382615
First received: April 12, 2010
Last updated: February 28, 2014
Last verified: February 2014
  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 ] [ Designated as safety issue: No ]
    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
Estimated Study Completion Date: December 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01382615     History of Changes
Other Study ID Numbers: D1029
Study First Received: April 12, 2010
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014