Clinical trial NCT00688168: Inflammatory Cytokines in Symptom Production in Multiple Myeloma
Official title: Identifying the Role of Inflammatory Cytokines in Symptom Production in Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Phone Call
Treatment Naive
Inflammatory Cytokines
Questionnaire
Survey
Interactive Voice Response
Symptom Production
Pain
IVR
MM
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-06-02
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, 18 years or older, diagnosed with multiple myeloma (MM).

Brief summary: 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.

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 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.

Primary outcomes:
measure: Multiple myeloma module of MDASI (MDASI-MM) Questionnaire
timeFrame: Baseline with 12 Month Longitudinal Assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Xin Shelley Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: