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Identifying the Role of Inflammatory Cytokines in Symptom Production in Multiple Myeloma

18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Identifying the Role of Inflammatory Cytokines in Symptom Production in Multiple Myeloma

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.

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Multiple myeloma module of MDASI (MDASI-MM) Questionnaire

Outcome Time Frame:

Baseline with 12 Month Longitudinal Assessment

Safety Issue:


Principal Investigator

Xin Shelley Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Phone Call
  • Treatment Naive
  • Inflammatory Cytokines
  • Questionnaire
  • Survey
  • Interactive Voice Response
  • Symptom Production
  • Pain
  • IVR
  • MM
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



UT MD Anderson Cancer Center Houston, Texas  77030