Monoclonal Gammopathy of Undetermined SignificanceNCT01955395
Genomic and Psychosocial Effects of the 3RP on Patients With MGUS and Smoldering Multiple Myeloma
A study testing Relaxation Response Resiliency Program (3RP) in people with Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
- What is being tested?
- Relaxation Response Resiliency Program (3RP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: Genomic and Psychosocial Effects of the Relaxation Response Resiliency Program (3RP) on Patients With MGUS and Smoldering Multiple Myeloma
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.
Read the detailed description
Before the research starts (screening): After signing this consent form, the participant will be asked some questions to find out if the participant can be in the research study:
- A medical history, which includes questions about the participant's physical and mental health, current medications, and any allergies.
If these tests show that the participant are eligible to participate in the research study, the participant will receive the study intervention. If the participant does not meet the eligibility criteria, the participant will not be able to participate in this research study.
- After the screening procedures confirm that the participant is eligible to participate in the research study:
- Collections Visit One: After the screening visit confirms that the participant is eligible to participate, the participant will be scheduled for Collections Visit One. At Collections Visit One, the participant will complete:
- A demographic questionnaire: This will include questions about the participant's age, gender and ethnicity.
- A series of questionnaires: These will ask the participant's about their overall wellness and take about 30-45 minutes to complete.
- A small blood sample collection: Trained nursing staff will take about 1.5 tablespoons of blood from a single prick to the participant's arm. This procedure will take about 10-15 minutes. This is to provide samples for research tests that may help the investigator's learn more about how the study treatment affects how the participant's genes are expressed.
- OPTIONAL - Bone marrow, plasma and serum collection: This collection is optional and is described in more detail in Section O. Trained nursing staff will take about 1 tablespoon of bone marrow through a standard bone marrow aspirate procedure. This procedure takes about 20-30 minutes to complete, however most of the time is used to get everything ready (such as preparing the skin) as well as 5-10 minutes reserved for relaxing after the procedure is completed. This is to provide samples for research tests that may help the investigator learn more about how the study treatment affects the participant's disease. (This collection is optional and is described in more detail in section O.)
- Since the effect of the study intervention with other medications may not be known, it is important that the participant tell the research doctor about all prescription and non-prescription drugs, herbal preparations and nutritional supplements that the participant is taking or is planning to take.
- Randomization: In order to measure the effects of the intervention, the participant will be "randomized" into one of the study groups after Collections
- Visit One: Immediate Group or Waitlist Control. The Immediate Group will receive the study intervention within two weeks after the Screening and Collections Visit One procedures. Randomization means that the participant is put into a group by chance. It is like flipping a coin. The participant will have an equal chance of being placed in either group. Both groups will receive the same intervention during the course of the study, but at different time points.
- If the participant is assigned to the Waitlist Control group, Collections Visit One will be followed by 3 months of waiting for the intervention. The participant would then attend Collections Visit Two, followed by the intervention (3 months) and then by Collections Visit Three.
- If the participant is assigned to the Immediate Group, Collections Visit One will be followed by the intervention (3 months). the participant would then attend Collections Visit Two, followed by 3 months of continuing to practice what the participant learned during the intervention, and then by Collections Visit Three.
- After Collections Visit One, the participant will be given a group assignment and a calendar of future study visits indicating the potential date, time and locations of the participant's study visits.
- Study Intervention: 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. All intervention visits will take place at the Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hospital.
- During the intervention (and follow up period for those in the Immediate Group), 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.
- Collections Visit Two: This visit will be the same as Collections Visit One.
- Collections Visit Three: During this visit, the participant will complete:
- A series of questionnaires: These will ask about the participant's overall wellness, and will take about 30-45 minutes to complete.
- A small blood sample collection: Trained nursing staff will take about 1.5 tablespoons of blood from a single prick to your arm. This procedure takes about 10-15 minutes. This is to provide samples for research tests that may help the investigators learn more about how the study treatment affects how the participant's genes are expressed.
- The investigators will also collect information regarding any changes in the participants medical history since their last visit.
Research Study Plan:
Immediate Group
- Screening Visit: Week 1
- Collections Visit One: Week 1 or 2
- 3RP Session One: Week 3
- 3RP Session Two: Week 4
- 3RP Session Three: Week 5
- 3RP Session Four: Week 6
- 3RP Session Five: Week 7
- 3RP Session Six: Week 8
- 3RP Session Seven: Week 9
- 3RP Session Eight: Week 10
- Collections Visit Two: Week 11/12
- Follow Up Period (home practice): Weeks 13-21 Collections Visit Three: Week 22-24
Waitlist Control
- Screening Visit: Week 1
- Collections Visit One: Week 1 or 2
- Waiting Period: Weeks 2-10
- Collections Visit Two: Week 11 or 12
- 3RP Session One: Week 13
- 3RP Session Two: Week 14
- 3RP Session Four: Week 15
- 3RP Session Five: Week 16
- 3RP Session Six: Week 17
- 3RP Session Seven: Week 18
- 3RP Session Eight: Week 19
- Collections Visit Three: Week 22, 23, or 24
- Planned Follow-up (Immediate Group Only): The investigator would like to keep track of the participant's home practice and medical condition for 12 weeks after completion of the 3RP intervention. The investigator would like to do this by contacting the participant by e-mail or phone once a month to see how the participant is doing. By Keeping in touch with the participant and checking on their practice and condition every month helps the investigator look at the long-term effects of the research study. At the end of the 12 weeks, the participant will come in for their last study visit - the follow up visit, which is described above.
- Being tested
- Relaxation Response Resiliency Program (3RP)
- Keywords
- Relaxation Response Resiliency Program (3RP), monoclonal gammopathy of undetermined significance, smoldering multiple myeloma
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Response Resiliency Program (3RP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Group | Active comparator | 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. Receives: Behavioral: Relaxation Response Resiliency Program (3RP) |
| Waitlist Group | Active comparator | 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). Receives: Behavioral: Relaxation Response Resiliency Program (3RP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline to 3 months
Secondary outcomes (8)
Expression of the previously-defined RR-signature in PBMCs
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.
Measured: baseline to 3 months
Gene expression levels in PBMCs
Normalized gene expression levels in peripheral blood mononuclear cells using nanostring technology.
Measured: baseline to 3 months
PSS-10 score
Change in the 10-item perceived stress scale score.
Measured: baseline to 3 months
Normalized gene expression levels in clonal, CD138+ BMPCs
Normalized gene expression levels in clonal, CD138+ bone marrow plasma cells (BMPCs) measured using nanostring technology.
Measured: baseline to 3 months
Beck Anxiety Inventory score
Change in the Beck Anxiety Inventory score.
Measured: baseline to 3 months
Penn State Worry Questionnaire score
Change in the Penn State Worry Questionnaire score.
Measured: baseline to 3 months
LOT-R score
Change in the Life Orientation Test-Revised score.
Measured: baseline to 3 months
MOCS score
Change in the Measure of Current Status score.
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Monoclonal Gammopathy of Undetermined SignificanceStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John W. Denninger, MD, PhD, Massachusetts General Hospital
- Investigators
- John Denninger, MD/PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955395
- Sponsor's protocol ID
- 13-266
- Status last verified
- Mar 2017
- First submitted
- 23 Sep 2013
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40681960
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic and Psychosocial Effects of the Relaxation Response Resiliency Program (3RP) on Patients With MGUS and Smoldering Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01955395
- Acronym / sponsor ID
- 13-266
- Keywords
- Relaxation Response Resiliency Program (3RP), monoclonal gammopathy of undetermined significance, smoldering multiple myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Before the research starts (screening): After signing this consent form, the participant will be asked some questions to find out if the participant can be in the research study:
- A medical history, which includes questions about the participant's physical and mental health, current medications, and any allergies.
If these tests show that the participant are eligible to participate in the research study, the participant will receive the study intervention. If the participant does not meet the eligibility criteria, the participant will not be able to participate in this research study.
- After the screening procedures confirm that the participant is eligible to participate in the research study:
- Collections Visit One: After the screening visit confirms that the participant is eligible to participate, the participant will be scheduled for Collections Visit One. At Collections Visit One, the participant will complete:
- A demographic questionnaire: This will include questions about the participant's age, gender and ethnicity.
- A series of questionnaires: These will ask the participant's about their overall wellness and take about 30-45 minutes to complete.
- A small blood sample collection: Trained nursing staff will take about 1.5 tablespoons of blood from a single prick to the participant's arm. This procedure will take about 10-15 minutes. This is to provide samples for research tests that may help the investigator's learn more about how the study treatment affects how the participant's genes are expressed.
- OPTIONAL - Bone marrow, plasma and serum collection: This collection is optional and is described in more detail in Section O. Trained nursing staff will take about 1 tablespoon of bone marrow through a standard bone marrow aspirate procedure. This procedure takes about 20-30 minutes to complete, however most of the time is used to get everything ready (such as preparing the skin) as well as 5-10 minutes reserved for relaxing after the procedure is completed. This is to provide samples for research tests that may help the investigator learn more about how the study treatment affects the participant's disease. (This collection is optional and is described in more detail in section O.)
- Since the effect of the study intervention with other medications may not be known, it is important that the participant tell the research doctor about all prescription and non-prescription drugs, herbal preparations and nutritional supplements that the participant is taking or is planning to take.
- Randomization: In order to measure the effects of the intervention, the participant will be "randomized" into one of the study groups after Collections
- Visit One: Immediate Group or Waitlist Control. The Immediate Group will receive the study intervention within two weeks after the Screening and Collections Visit One procedures. Randomization means that the participant is put into a group by chance. It is like flipping a coin. The participant will have an equal chance of being placed in either group. Both groups will receive the same intervention during the course of the study, but at different time points.
- If the participant is assigned to the Waitlist Control group, Collections Visit One will be followed by 3 months of waiting for the intervention. The participant would then attend Collections Visit Two, followed by the intervention (3 months) and then by Collections Visit Three.
- If the participant is assigned to the Immediate Group, Collections Visit One will be followed by the intervention (3 months). the participant would then attend Collections Visit Two, followed by 3 months of continuing to practice what the participant learned during the intervention, and then by Collections Visit Three.
- After Collections Visit One, the participant will be given a group assignment and a calendar of future study visits indicating the potential date, time and locations of the participant's study visits.
- Study Intervention: 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. All intervention visits will take place at the Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hospital.
- During the intervention (and follow up period for those in the Immediate Group), 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.
- Collections Visit Two: This visit will be the same as Collections Visit One.
- Collections Visit Three: During this visit, the participant will complete:
- A series of questionnaires: These will ask about the participant's overall wellness, and will take about 30-45 minutes to complete.
- A small blood sample collection: Trained nursing staff will take about 1.5 tablespoons of blood from a single prick to your arm. This procedure takes about 10-15 minutes. This is to provide samples for research tests that may help the investigators learn more about how the study treatment affects how the participant's genes are expressed.
- The investigators will also collect information regarding any changes in the participants medical history since their last visit.
Research Study Plan:
Immediate Group
- Screening Visit: Week 1
- Collections Visit One: Week 1 or 2
- 3RP Session One: Week 3
- 3RP Session Two: Week 4
- 3RP Session Three: Week 5
- 3RP Session Four: Week 6
- 3RP Session Five: Week 7
- 3RP Session Six: Week 8
- 3RP Session Seven: Week 9
- 3RP Session Eight: Week 10
- Collections Visit Two: Week 11/12
- Follow Up Period (home practice): Weeks 13-21 Collections Visit Three: Week 22-24
Waitlist Control
- Screening Visit: Week 1
- Collections Visit One: Week 1 or 2
- Waiting Period: Weeks 2-10
- Collections Visit Two: Week 11 or 12
- 3RP Session One: Week 13
- 3RP Session Two: Week 14
- 3RP Session Four: Week 15
- 3RP Session Five: Week 16
- 3RP Session Six: Week 17
- 3RP Session Seven: Week 18
- 3RP Session Eight: Week 19
- Collections Visit Three: Week 22, 23, or 24
- Planned Follow-up (Immediate Group Only): The investigator would like to keep track of the participant's home practice and medical condition for 12 weeks after completion of the 3RP intervention. The investigator would like to do this by contacting the participant by e-mail or phone once a month to see how the participant is doing. By Keeping in touch with the participant and checking on their practice and condition every month helps the investigator look at the long-term effects of the research study. At the end of the 12 weeks, the participant will come in for their last study visit - the follow up visit, which is described above.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Group | Active comparator | Behavioral: Relaxation Response Resiliency Program (3RP)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. |
| Waitlist Group | Active comparator | Behavioral: Relaxation Response Resiliency Program (3RP)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Immediate Group, Waitlist Group |
Primary outcome
NF-κB pathway expression in PBMCs
Time frame: baseline to 3 months
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).
8 secondary outcomes
Expression of the previously-defined RR-signature in PBMCs
Time frame: baseline to 3 months
Gene expression levels in PBMCs
Time frame: baseline to 3 months
PSS-10 score
Time frame: baseline to 3 months
Normalized gene expression levels in clonal, CD138+ BMPCs
Time frame: baseline to 3 months
Beck Anxiety Inventory score
Time frame: baseline to 3 months
Penn State Worry Questionnaire score
Time frame: baseline to 3 months
LOT-R score
Time frame: baseline to 3 months
MOCS score
Time frame: baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Derived from this study: PubMed 40681960Finkelstein-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Denninger, MD/PhD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Response Resiliency Program (3RP) in people with Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NF-κB pathway expression in PBMCs (time frame: baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01955395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.