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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
John W. Denninger, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01955395
First received: September 23, 2013
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma
Behavioral: Relaxation Response Resiliency Program (3RP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Genomic and Psychosocial Effects of the Relaxation Response Resiliency Program (3RP) on Patients With MGUS and Smoldering Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • NF-κB pathway expression in PBMCs [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Expression of the previously-defined RR-signature in PBMCs [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    The expression of previously-defined RR-signature in peripheral blood mononuclear cells (PBMCs) will be determined on the basis of cumulative expression of normalized copy number of all the genes in the signature. The genes for the signature are defined in Bhasin et al., PLoSOne, 2013.

  • Gene expression levels in PBMCs [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    Normalized gene expression levels in peripheral blood mononuclear cells using nanostring technology.

  • PSS-10 score [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    Change in the 10-item perceived stress scale score.

  • Normalized gene expression levels in clonal, CD138+ BMPCs [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    Normalized gene expression levels in clonal, CD138+ bone marrow plasma cells (BMPCs) measured using nanostring technology.

  • Beck Anxiety Inventory score [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    Change in the Beck Anxiety Inventory score.

  • Penn State Worry Questionnaire score [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    Change in the Penn State Worry Questionnaire score.

  • LOT-R score [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    Change in the Life Orientation Test-Revised score.

  • MOCS score [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    Change in the Measure of Current Status score.


Estimated Enrollment: 96
Study Start Date: October 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate Group
If 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.
Behavioral: Relaxation Response Resiliency Program (3RP)
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.
Active Comparator: Waitlist Group
If 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).
Behavioral: Relaxation Response Resiliency Program (3RP)
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955395

Contacts
Contact: John Denninger, MD/PhD 617-726-2985 jdenninger@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: John Denninger, MD/PhD    617-726-2985    jdenninger@partners.org   
Principal Investigator: John Denninger, MD/PhD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacob Laubach, MD    617-632-4218    jacobp_laubach@dfci.harvard.edu   
Principal Investigator: Jacob Laubach, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Towia Libermann, MD    617-667-0760    tliberma@bidmc.harvard.edu   
Principal Investigator: Towia Libermann, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: John Denninger, MD/PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: John W. Denninger, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01955395     History of Changes
Other Study ID Numbers: 13-266
Study First Received: September 23, 2013
Last Updated: October 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Relaxation Response Resiliency Program (3RP)
monoclonal gammopathy of undetermined significance
smoldering multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Monoclonal Gammopathy of Undetermined Significance
Paraproteinemias
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia

ClinicalTrials.gov processed this record on September 16, 2014