Genomic and Psychosocial Effects of the 3RP on Patients With MGUS and Smoldering Multiple Myeloma
1 other identifier
interventional
93
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2013
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMarch 16, 2017
March 1, 2017
2.9 years
September 23, 2013
March 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NF-κB pathway expression in PBMCs
The expression of the NF-kB pathway in peripheral blood mononuclear cells will be determined on the basis of cumulative expression of normalized copy number of all the genes in the pathway. The genes for the NF-kB pathway will be obtained from the MSigDB (Molecule Signature Database) 3.0 (Broad Institute).
baseline to 3 months
Secondary Outcomes (8)
Expression of the previously-defined RR-signature in PBMCs
baseline to 3 months
Gene expression levels in PBMCs
baseline to 3 months
PSS-10 score
baseline to 3 months
Normalized gene expression levels in clonal, CD138+ BMPCs
baseline to 3 months
Beck Anxiety Inventory score
baseline to 3 months
- +3 more secondary outcomes
Study Arms (2)
Immediate Group
ACTIVE COMPARATORIf the participant is assigned to the Immediate Group, the participant will immediately receive the Relaxation Response Resiliency Program (3RP) intervention (3 months), followed by 3 months of continuing to practice what the participant learned during the intervention.
Waitlist Group
ACTIVE COMPARATORIf the participant is assigned to the Waitlist Group, the participant will wait for 3 months and then receive the full Relaxation Response Resiliency Program (3RP) intervention (3 months).
Interventions
The intervention will consist of one intake with a psychologist (approximately 60 minutes), 8 3RP sessions once a week over the course of 8 weeks (approximately 1 hour and 30 minutes each), and one exit visit (approximately 30 minutes) over the course of 3-months. During the intervention, the participant will be asked to practice what the participant has learned in the intervention by listening to a 20-minute audio CD daily. Additionally, the participant will be asked to keep track of their daily practice by filling out an online or paper log. During the 3RP session, the clinician will address any barriers or problems the participant may be having with the daily practice and help to problem solve them with the participant.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Massachusetts General Hospital
Boston, Massachusetts, 02215, United States
Related Publications (1)
Finkelstein-Fox L, Denninger JW, Walsh LE, Laubach JP, Yee AJ, O'Donnell E, Macklin EA, Gu X, Muzikansky A, Libermann TA, Nicolosi G, Richardson PG, Raje NS, Fricchione GL, Perez GK, Traeger LN, Chad-Friedman E, Park ER. Psychosocial and NF-kappaB Activity Effects of the Stress Management and Resiliency Training: Relaxation Response Resiliency Program (SMART-3RP) on Patients With MGUS and Smoldering Multiple Myeloma: A Randomized Waitlist Control Trial. Psychooncology. 2025 Jul;34(7):e70216. doi: 10.1002/pon.70216.
PMID: 40681960DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Denninger, MD/PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 23, 2013
First Posted
October 7, 2013
Study Start
October 1, 2013
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
March 16, 2017
Record last verified: 2017-03