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 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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Behavioral: Questionnaire; Behavioral: Neurocognitive Testing; Behavioral: Neurosensory Testing

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.

• Study Type: Observational
• Enrollment (Actual): 491

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Multiple myeloma module of MDASI (MDASI-MM) Questionnaire	Baseline with 12 Month Longitudinal Assessment

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: AstraZeneca

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2008
• Primary Completion (ACTUAL): January 8, 2019
• Study Completion (ACTUAL): January 8, 2019

Study Registration Dates

• First Submitted: May 28, 2008
• First Submitted That Met QC Criteria: May 30, 2008
• First Posted (ESTIMATE): June 2, 2008

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Pain; Questionnaire; Survey; Treatment Naive; MM; IVR; Interactive Voice Response; Inflammatory Cytokines; Phone Call; Symptom Production
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 2007-0612

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No