Inflammatory Cytokines in Symptom Production in Multiple Myeloma

NCT00688168 | Completed

• 1 other identifier: 2007-0612
• Study Type: observational
• Target: 491
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Phone Call; Treatment Naive; Inflammatory Cytokines; Questionnaire; Survey; Interactive Voice Response; Symptom Production; Pain; IVR; MM

Outcome Measures

Primary Outcomes (1)

• Multiple myeloma module of MDASI (MDASI-MM) Questionnaire

  Baseline with 12 Month Longitudinal Assessment

Study Arms (1)

Symptom Assessments

Patients diagnosed with multiple myeloma (MM) complete questionnaires with Neurocognitive Testing and Neurosensory Testing

Behavioral: Questionnaire; Behavioral: Neurocognitive Testing; Behavioral: Neurosensory Testing

Interventions

Questionnaire BEHAVIORAL

Questionnaires measuring pain and other symptoms, mood, and quality of life.

Also known as: Survey

Symptom Assessments

Neurocognitive Testing BEHAVIORAL

A neurocognitive exam (tests to check your memory and thinking abilities, for example) will be performed.

Symptom Assessments

Neurosensory Testing BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Must speak and understand English;
• 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).
• Patients \>= 18 years old.

You may not qualify if:

• Patients who do not understand the intent of the study, so cannot or will not give informed consent
• Patients who are unable to use the Interactive Voice Response (IVR) system due to physical limitations (e.g., hearing impairment).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

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.

MeSH Terms

Conditions

Multiple Myeloma; Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Xin Shelley Wang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: May 9, 2008
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

US (1)