Inflammatory Cytokines in Symptom Production in Multiple Myeloma



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:1/27/2018
Start Date:May 2008
End Date:May 2020

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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.

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.

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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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