Genomic and Psychosocial Effects of the 3RP on Patients With MGUS and Smoldering Multiple Myeloma

Status: Recruiting
Phase: N/A
Diagnosis: Multiple Myeloma
NCT ID: NCT01955395 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-266

 

This research study is evaluating the effects of a mind body medicine intervention called the Relaxation Response Resiliency Program (3RP) on stress and stress related symptoms in patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). This research study is a supportive care trial. This means that the intervention program may improve general well-being and comfort, but is not considered a treatment or "cure" for MGUS or SMM. It is considered an investigational intervention because the investigators are examining the effectiveness of a new program - the 3RP - on reducing stress and stress-related symptoms in patients with MGUS and SMM. Standard management of MGUS and SMM involves regular monitoring without chemotherapy. Mind-body medicine, as defined by the National Institutes of Health, "focuses on the interactions among the brain, mind, body, and behavior, and on the powerful ways in which emotional, mental, social, spiritual, and behavioral factors can directly affect health." The 3RP is a newly designed group therapy program that through a variety of mind body principles and self-care interventions seeks to buffer stress and promote psychological resiliency and physical well-being. This study will examine the effectiveness of the 3RP in reducing stress and symptoms associated with stress in patients diagnosed with MGUS or SMM. Data from this study will also be used to assess changes in gene expression that result from 3RP intervention, particularly genetic pathways that are known to be dysregulated in MM.

 

Conducting Institutions:
Massachusetts General Hospital, Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute

Overall PI:
John Denninger, MD/PhD, Massachusetts General Hospital

Site-responsible Investigators:
Manoj Bhasin, PhD, Beth Israel Deaconess Medical Center
Jacob Laubach, MD, Dana-Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Participants must have confirmed high-risk monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM) as defined below in table #. MGUS - Serum monoclonal protein level < 3 g/dL but > 1.5g/dl, - Bone marrow plasma cells < 10% - Non-IgG MGUS (ie IgA, IgM, IgD MGUS) - Abnormal serum free light chain ratio (ie ratio of kappt to lambda free light chains < 0.26 or > 1.65) - Absence of end-organ damage, such as lytic bone lesions, anemia, hypercalcemia, or renal failure, that can be attributed to a plasma cell proliferative disorder SMM (also referred to as asymptomatic multiple myeloma) - Serum monoclonal protein (IgG or IgA) level > 3 g/dL, - and /or bone marrow plasma cells > 10%, - absence of end-organ damage, such as lytic bone lesions, anemia, hypercalcemia, or renal failure, that can be attributed to a plasma cell proliferative disorder - Participants must be at least 18 years old. Because no dosing or adverse event data are currently available on the use of RR in participants <18 years of age, children are excluded from this study. - The effects of RR on the developing human fetus are unknown. For this reason, should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study. - Participants with concurrent active cancer or active cancer with in the last 5 years are ineligible. - Participants with serious or unstable illness, as determined by study physicians and clinicians, may be deemed unfit to participate. - Participants with current bipolar or psychotic disorders with active symptoms or treatment within the last 5 year will be excluded. - Participants will be excluded if they are currently taking (within the last 6 months) psychoactive medications (e.g. mood stabilizers, antipsychotics), with the exception of hypnotics and antidepressants, which will be permitted. - Participants may not be receiving any other study agents.
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