Inflammatory Cytokines in Symptom Production in Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00688168
First received: May 28, 2008
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

The goal of this research study is to learn about the pain and/or other symptoms that patients may experience either while you are being monitored by your doctor before a decision is made to start you on treatment for your MM, or during and after treatment for MM, and how these symptoms may affect therapy. A second goal is to learn how differences in genes may affect the symptom burden from cancer and cancer therapy.


Condition Intervention
Multiple Myeloma
Behavioral: Questionnaire
Behavioral: Neurocognitive Testing
Behavioral: Neurosensory Testing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identifying the Role of Inflammatory Cytokines in Symptom Production in Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Multiple myeloma module of MDASI (MDASI-MM) Questionnaire [ Time Frame: Baseline with 12 Month Longitudinal Assessment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue sample by inserting a swab into mouth and rubbing firmly against the inside of cheeck or underneath lower or upper lip for about a minute during a regularly schedule clinic visit.


Estimated Enrollment: 625
Study Start Date: May 2008
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Symptom Assessments
Patients diagnosed with multiple myeloma (MM) complete questionnaires with Neurocognitive Testing and Neurosensory Testing
Behavioral: Questionnaire
Questionnaires measuring pain and other symptoms, mood, and quality of life.
Other Name: Survey
Behavioral: Neurocognitive Testing
A neurocognitive exam (tests to check your memory and thinking abilities, for example) will be performed.
Behavioral: Neurosensory Testing
Neurosensory testing will be performed to find out how sensitive you are to things such as touch, coolness, warmth, pinprick on the finger, and squeezing of the skin on the finger, hand, or arm.

Detailed Description:

If you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled clinic visit. These questionnaires will measure pain and other symptoms, such as your mood and quality of life. You will also be asked to give a tissue sample by inserting a swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about a minute at most. Completing the 5 questionnaires and the swab sample collection takes about 30 minutes in total.

This is an investigational study.

Up to 500 patients will take part in the cross-sectional phase of this study. All will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients, 18 years or older, diagnosed with multiple myeloma (MM).

Criteria

Inclusion Criteria:

  1. Must speak and understand English;
  2. Must be diagnosed with MM and meet one of the following criteria: 1) have been treated for MM with steroids only, or have received no more than two cycles of induction chemotherapy for MM and are going to be treated with bortezomib or thalidomide for induction therapy; 2) have received induction therapy and have been approved (or are being approved) medically and financially to receive autologous hematopoietic stem cell transplantation (Auto-HSCT); 3) cross sectional study patients will be either with a current diagnosis of asymptomatic MM not receiving treatment; or at least 12 months from the MM diagnosis, had received induction therapy, with or without received autologous hematopoietic stem cell transplantation (Auto-HSCT) and follow-up treatments. This cohort for a cross sectional survey may include the cases been enrolled, either completed or dropped from the same study. It may also include patients who did not participate on the first phase of the protocol (longitudinal cohort).
  3. Patients >= 18 years old.

Exclusion Criteria:

  1. Patients who do not understand the intent of the study, so cannot or will not give informed consent
  2. Patients who are unable to use the Interactive Voice Response (IVR) system due to physical limitations (e.g., hearing impairment).
  3. Induction therapy patients with a neuropathy score of 3 or greater on the NCI's Common Terminology Criteria (CTC version 3.0) either at the beginning of induction chemotherapy or after 1-2 cycles of chemotherapy as a result of previous treatment or from some other comorbid cause. This exclusion criteria does apply to the auto-HSCT patients.
  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: NCT00688168

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
AstraZeneca
Investigators
Principal Investigator: Xin Shelley Wang, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00688168     History of Changes
Other Study ID Numbers: 2007-0612
Study First Received: May 28, 2008
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Phone Call
Treatment Naive
Inflammatory Cytokines
Questionnaire
Survey
Interactive Voice Response
Symptom Production
Pain
IVR
MM

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 October 01, 2014