Inflammatory Cytokines in Symptom Production in Multiple Myeloma

This study is currently recruiting participants.
Verified July 2012 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00688168
First received: May 28, 2008
Last updated: July 25, 2012
Last verified: July 2012

May 28, 2008
July 25, 2012
May 2008
May 2014   (final data collection date for primary outcome measure)
Multiple myeloma module of MDASI (MDASI-MM) Questionnaire [ Time Frame: Baseline with 12 Month Longitudinal Assessment ] [ Designated as safety issue: No ]
The goal of this research study is to learn about the pain and/or other symptoms that patients may experience during and after treatment for MM and how these symptoms may affect therapy. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00688168 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Inflammatory Cytokines in Symptom Production in Multiple Myeloma
Identifying the Role of Inflammatory Cytokines in Symptom Production in Multiple Myeloma

The goal of this research study is to learn about the pain and/or other symptoms that patients may experience 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.

If you agree to take part in this study, you will complete 4 questionnaires during a regularly schedule 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.

Length of Study:

After you have completed the 5 questionnaires and the swab sample collection, your participation in this study will be over.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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

Multiple Myeloma
  • 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.
Symptom Assessments
Patients diagnosed with multiple myeloma (MM)
Interventions:
  • Behavioral: Questionnaire
  • Behavioral: Neurocognitive Testing
  • Behavioral: Neurosensory Testing
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
 
May 2014   (final data collection date for primary outcome measure)

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 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 (CTCv3.0) 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.
Both
18 Years and older
No
Contact: Xin Shelley Wang, MD 713-745-3470
United States
 
NCT00688168
2007-0612
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
AstraZeneca
Principal Investigator: Xin Shelley Wang, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

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