MDACC Study Summary 2007-0612

Study Summary
No. 2007-0612:.......Myeloma......Xin Shelley Wang......Symptom Research

Study Summary Title



Study Summary Number:	2007-0612

Study Title:	Identifying the role of inflammatory cytokines in symptom production in multiple myeloma

Physician

New Patient Referral



Name:	Xin Shelley Wang	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Symptom Research	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3470 Contact us about clinical trials

General Information



Disease Group:	Myeloma	Supported By:	AstraZeneca

Phase of Study:	N/A	Return Visit:	Per every cycle of chemotherapy when treating physician reviews patient's ongoing condition.

Treatment Agents:	Questionnaire	Home Care:	Not required, not an intervention study.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not required, not an intervention study.


Description/ Intervention:	The goal of this research study is 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. A second goal is to learn how differences in genes may affect the symptom burden from cancer and cancer therapy.

Study Objectives / Outcomes

1.1: 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.

1.2: 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-naīve 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.

1.3: To study the association between cytokines and symptom burden driven solely by MM disease in treatment-naīve 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-naīve patients.

1.4: 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.

1.5: 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.

1.6: To characterize neurocognitive and neuropsychiatric symptoms in patients with MM using a neuropsychological test battery. 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.

1.7: To evaluate the major symptom burden for MM patients during 1-5 years post-diagnosis. These patients may continue to receive treatment or may be under observation only.

1.8: To analyze genetic variation from inflammation and other symptom-related genes with regard to risk of developing high symptom burden from cancer and therapy in patients with MM.

Study Status Information



Study Activation / Registration Date:	05/09/2008

IRB Review and Approval Date:	01/28/2008

Study Type:	Other

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 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 censent

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 (CTCv3.0) 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.

Links

Registration Number: NCT00688168
Study Information on Clinical Trials Registry (clinicaltrials.gov)