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Inflammatory Cytokines in Symptom Production in Multiple Myeloma
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, January 2009
Sponsors and Collaborators: M.D. Anderson Cancer Center
AstraZeneca
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00688168
  Purpose

Objectives:

  1. To estimate the effects of novel induction agents on reducing multiple myeloma (MM)-related symptoms and associated dynamic changes in interleukin (IL)-6. We will test the hypothesis that during induction therapy, patients with greater reduction in tumor markers (M-protein) will report greater relief of MM-related symptoms (bone pain, fatigue) related to lower serum IL-6 levels and, possibly, to reduced nuclear factor-kappa B (NF-kB) activation levels.
  2. To determine the course of the development of neuropathic pain caused by induction therapy and its association with serum tumor necrosis factor (TNF)-a in treatment-naïve patients with MM. We will test the hypothesis that patients report increasingly severe neuropathy (beginning with hand and foot numbness and increasing gradually to pain) related to increasing levels of serum TNF-a.
  3. To study the association between cytokines and symptom burden driven solely by MM disease in treatment-naïve patients by examining serum cytokines and symptoms prior to cancer treatment. The acquisition of such baseline knowledge is necessary to the further development and interpretation of models correlating both disease-related and treatment-driven cytokines and symptoms. We hypothesize that, controlled for host factors, preinduction serum levels of certain overexpressed proinflammatory cytokines (IL-6, TNF-a) and their upstream marker NF-kB and product (C-reactive protein [CRP]) will directly relate to elevated severity of MM-related symptoms (bone pain and fatigue) in treatment-naïve patients.
  4. To study multiple symptom development in acute phase of autologous stem cell transplantation (auto-SCT) for MM patients, and the symptom severity related level of serum inflammatory cytokines (Mainly IL-6). We hypothesize that, nadir related symptom burden is associated with significant increase of pro inflammatory cytokines (IL-6 as domain) that caused by pretransplant chemotherapy, conditioning and the stem cell transplant.
  5. To track primary afferent function by quantitative sensory testing over time during chemotherapy in patients with MM. We hypothesize that patients being treated with novel agents and who develop neurosensory changes will exhibit reduction in primary afferent fiber function as reflected in the sensory testing measures.
  6. To characterize neurocognitive and neuropsychiatric symptoms in patients with MM using a neuropsychological test battery at baseline and every 3 months thereafter and at off-study. We hypothesize that approximately one third of patients with MM will develop impairments of memory, executive function, and fine-motor speed during and after cancer treatment.

Condition Intervention
Multiple Myeloma
Behavioral: Questionnaire
Behavioral: Phone Call
Behavioral: Neurocognitive Testing
Behavioral: Neurosensory Testing

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Identifying the Role of Inflammatory Cytokines in Symptom Production in Multiple Myeloma

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To learn about the pain and/or other symptoms that patients may experience during and after treatment for MM and how these symptoms may affect therapy. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 125
Study Start Date: May 2008
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients diagnosed with multiple myeloma (MM).
Behavioral: Questionnaire
Questionnaires measuring pain and other symptoms, mood, and quality of life.
Behavioral: Phone Call
A telephone system will call 2 times a week for 12 weeks to rate your symptoms and how they may be interfering with daily activities.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with multiple myeloma (MM).

Criteria

Inclusion Criteria:

  • Must speak either English or Spanish
  • Must be diagnosed with MM and be either treatment naive, or have had only one cycle of treatment;
  • Patients who qualified and are to receive induction therapy that includes bortezomib, lenalidomide, or thalidomide;
  • Patients >= 18 years old.

Exclusion Criteria:

  • 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).
  • Patients with a neuropathy score of 1 or greater on the NCI's Common Terminology Criteria (CTCv3.0).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688168

Contacts
Contact: Xin Shelley Wang, MD 713-745-3470

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Xin Shelley Wang, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
AstraZeneca
Investigators
Principal Investigator: Xin Shelley Wang, MD U.T.M.D. Anderson Cancer Center
  More Information

UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Xin Shelley Wang, MD/Associate Professor )
Study ID Numbers: 2007-0612
Study First Received: May 28, 2008
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00688168  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Phone Call
Treatment Naive
Inflammatory Cytokines
Questionnaire
Survey
Interactive Voice Response
Symptom Production
Pain
IVR
MM

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Pain
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009