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Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma

Primary Purpose

Plasma Cell Myeloma, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Beta-Adrenergic Antagonist
Propranolol
Quality-of-Life Assessment
Questionnaire Administration
Resistance Training
Short-Term Fasting
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plasma Cell Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >= 18 years of age
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of:

    • Module A: ECOG 0 - 1
    • Module B: ECOG 0 - 2
    • Module C: ECOG 0 - 2
  • Have a diagnosis of smoldering multiple myeloma or multiple myeloma
  • Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion
  • Are able to understand and follow assessment and intervention procedures
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
  • MODULE A (PHYSICAL ACTIVITY): Participant has access to a personal computer or tablet with camera, microphone, speakers and internet access
  • MODULE B (NUTRITION): Not applicable
  • MODULE C (BETA BLOCKER): Newly diagnosed patients with multiple myeloma necessitating treatment and before initiation of systemic therapy
  • MODULE C (BETA BLOCKER): Eligibility for autologous stem cell transplantation
  • MODULE C (BETA BLOCKER): Bone marrow biopsy planned as standard of care at first diagnosis and before stem cell collection (Flow Cytometry Standard of Care [SOC] - III)
  • MODULE C (BETA BLOCKER): Female participants of child-bearing potential must have a negative pregnancy test at study entry and then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Male patients with female partners of child-bearing potential should also use adequate contraceptive methods (see above). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • CRITERIA FOR SELINEXOR SUBSTUDY: Age >= 18 years of age
  • CRITERIA FOR SELINEXOR SUBSTUDY: Multiple myeloma with planned treatment with selinexor or one of its combinations (to include selinexor/bortezomib/dexamethasone [SVd], selinexor/carfilzomib/dexamethasone [SKd], selinexor/pomalidomide/dexamethasone [SPd], and selinexor/daratumumab/dexamethasone [SDd])
  • CRITERIA FOR SELINEXOR SUBSTUDY: Have an ECOG Performance Status of 0 - 2
  • CRITERIA FOR SELINEXOR SUBSTUDY: Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion
  • CRITERIA FOR SELINEXOR SUBSTUDY: Are able to understand and follow assessment and training procedures
  • CRITERIA FOR SELINEXOR SUBSTUDY: Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Major comorbidities that would cause danger to the patient when participating in the study and that would have a risk of progression if the patient took part in the study (including, but not limited to): cardiac or pulmonary and infectious diseases (e.g., ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) or, psychiatric illness/social situations that would limit compliance with study requirements
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention (comorbidities, myeloma symptoms, treatment side effects)
  • MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system that is deemed to making the patient unsafe to participate. This will be assessed by radiologist, a neurosurgeon and/or an orthopedic surgeon, if applicable.
  • MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system
  • MODULE A (PHYSICAL ACTIVITY): Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced surgeon
  • MODULE B (NUTRITION): Clinical signs of malnutrition (body mass index [BMI] < 18)
  • MODULE B (NUTRITION): Special diets (physician prescribed)
  • MODULE B (NUTRITION): Diabetic treated with glucose-lowering medications and/or insulin
  • MODULE B (NUTRITION): Other reasons not to withhold food
  • MODULE B (NUTRITION): Any condition which in the investigator's opinion deems the participant an unsuitable candidate to limit food consumption
  • MODULE C (BETA BLOCKER): Current use of a beta blocker (includes all non-selective and beta-1 selective blockers) or, use of a beta-blocker within 3 months of study enrollment
  • MODULE C (BETA BLOCKER): Contraindications to the use of beta-blockers, e.g.; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree, uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association [NYHA] Grade III or IV), hypotension ( systolic blood pressure < 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (HbA1C > 8.5 or 12h fasting plasma glucose > 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded
  • MODULE C (BETA BLOCKER): Pregnant or nursing female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test

Sites / Locations

  • Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Module A (strength training, behavioral intervention)

Module B (intermittent fasting)

Module C Group I (propranolol)

Module C Group II (propranolol)

Arm Description

Patients undergo strength training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 6 months. Patients also wear a FitBit device and receive prompts via email or text on a cell phone or other electronic device to incrementally increase physical activity over 6 months.

Patients undergo intermittent fasting for 1 month. This consists of restricting all eating to a consecutive 8-hour time period each day followed by 16 consecutive hours of not eating.

Patients receive propranolol PO BID for 3 months.

Patients continue receiving beta-blocker regimen as per SOC for 3 months.

Outcomes

Primary Outcome Measures

Changes in immune cell subsets
Will be assessed by flow cytometry, comparing levels before and after one of three lifestyle interventions (physical exercise, intermittent fasting, beta blocker therapy). Will use a linear mixed model. Since the form of the model is unknown a priori, the power calculations are based on comparing any two timepoints using a two-sided paired t-test. With n=100, we have 80% power (at alpha = 0.05/3) to detect a difference of at least 0.33 standard deviations (SD).

Secondary Outcome Measures

Changes in the gut microbiome
Fecal samples will be collected and compared from group with physical exercise,compared to group doing intermittent fasting).
Comparison in bone markers
Will be assessed from intermittent fasting serum samples compared to serum samples of those doing physical exercise.
Changes in body composition
Dexa (bone density scan) will be performed at 1 and 3 months
Changes in stress
Significant differences among groups in the mean Perceived Stress Scale (PSS) score, which measures the stress severity perceived by the subjects in the last month. The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 40. Higher total scores indicate a worse outcome
Changes in anxiety
As assessed by the Generalized Anxiety Disorder 7-item Scale
Changes in fatigue as assessed by EORTC-LQLQ-FA12
12-item multidimensional fatigue questionnaire.The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). The range is 3. For the raw score, less points are considered to have a better outcome.
Change in functional status
basic assessment of physical activity before diagnosis will be compared to one administered at follow up
Changes in nutritional behavior before and after intermittent fasting
Will be modeled using a GEE logistic model. Rates of positive nutritional behavior will be compared beween time points.
Changes in stress-related biomarkers
Will be evaluated using a linear mixed model and will be used to compare mean levels between timepoints.

Full Information

First Posted
March 18, 2022
Last Updated
October 24, 2023
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05312255
Brief Title
Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma
Official Title
Improving Host Factors in Patients With Monoclonal Gammopathies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
June 28, 2025 (Anticipated)
Study Completion Date
June 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial investigates the effect of non-chemotherapeutic interventions in patients with multiple myeloma. Non-chemotherapeutic interventions such as physical activity and nutritional interventions (e.g., modifications in diet) have been shown to positively affect the immune system and improve overall quality of life. Another purpose of this study is for researchers to learn how the addition of a beta-blocker (propranolol) to the standard treatment regimen in patients with newly diagnosed multiple myeloma affects immune response and quality of life. A study from the Mayo Clinic looked at multiple myeloma patients who were on a beta-blocker while undergoing chemotherapy and found that the use of a beta-blocker resulted in improved patient survival outcomes. Non-chemotherapeutic treatment options may help decrease symptoms and improve quality of life for patients with multiple myeloma.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition, stress effects reduction) on immune markers in patients with monoclonal plasma cell disorders. SECONDARY OBJECTIVES: I. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition) on bone turnover parameters, body composition, the microbiome and physical fitness in patients with monoclonal plasma cell disorders. II. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition, stress effect reduction) on parameters of stress, mental health and quality of life in patients with monoclonal plasma cell disorders. OUTLINE: Patients are assigned to Module A, B or C. MODULE A: Patients undergo strength training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 6 months. Patients also wear a FitBit device and receive prompts via email or text on a cell phone or other electronic device to incrementally increase physical activity over 6 months. MODULE B: Patients undergo intermittent fasting for 1 month. This consists of restricting all eating to a consecutive 8-hour time period each day followed by 16 consecutive hours of not eating. MODULE C: Patients are assigned to group 1 (are not currently taking beta-blockers) or group 2 (current taking beta-blockers). GROUP I: Patients receive propranolol orally (PO) twice daily (BID) for 3 months. GROUP II: Patients continue receiving beta-blocker regimen as per standard of care (SOC) for 3 months. After completion of the study interventions, patients in module A are followed every 3 months for 1 year. Patients in module B are followed at 3 and 5 months. Patients in module C are followed for 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasma Cell Myeloma, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma, Smoldering Plasma Cell Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Module A (strength training, behavioral intervention)
Arm Type
Experimental
Arm Description
Patients undergo strength training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 6 months. Patients also wear a FitBit device and receive prompts via email or text on a cell phone or other electronic device to incrementally increase physical activity over 6 months.
Arm Title
Module B (intermittent fasting)
Arm Type
Experimental
Arm Description
Patients undergo intermittent fasting for 1 month. This consists of restricting all eating to a consecutive 8-hour time period each day followed by 16 consecutive hours of not eating.
Arm Title
Module C Group I (propranolol)
Arm Type
Experimental
Arm Description
Patients receive propranolol PO BID for 3 months.
Arm Title
Module C Group II (propranolol)
Arm Type
Active Comparator
Arm Description
Patients continue receiving beta-blocker regimen as per SOC for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments
Intervention Description
Wear a FitBit device and receive prompts for 6 months
Intervention Type
Drug
Intervention Name(s)
Beta-Adrenergic Antagonist
Other Intervention Name(s)
Beta Blocker, Beta-Adrenergic Blocking Agent, Beta-Blockers
Intervention Description
Receive beta-blocker regimen as per SOC
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
1-[(1-Methylethyl)amino]-3-(1-naphthalenyloxy)-2-propanol
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Resistance Training
Other Intervention Name(s)
Strength Training
Intervention Description
Undergo strength training for 6 months
Intervention Type
Other
Intervention Name(s)
Short-Term Fasting
Other Intervention Name(s)
Intermittent Fasting, Short-term Intermittent Fasting
Intervention Description
Participate in intermittent fasting
Primary Outcome Measure Information:
Title
Changes in immune cell subsets
Description
Will be assessed by flow cytometry, comparing levels before and after one of three lifestyle interventions (physical exercise, intermittent fasting, beta blocker therapy). Will use a linear mixed model. Since the form of the model is unknown a priori, the power calculations are based on comparing any two timepoints using a two-sided paired t-test. With n=100, we have 80% power (at alpha = 0.05/3) to detect a difference of at least 0.33 standard deviations (SD).
Time Frame
At baseline and at 1 year
Secondary Outcome Measure Information:
Title
Changes in the gut microbiome
Description
Fecal samples will be collected and compared from group with physical exercise,compared to group doing intermittent fasting).
Time Frame
At 1 and 3 months
Title
Comparison in bone markers
Description
Will be assessed from intermittent fasting serum samples compared to serum samples of those doing physical exercise.
Time Frame
At 1 and 3 months
Title
Changes in body composition
Description
Dexa (bone density scan) will be performed at 1 and 3 months
Time Frame
3 months
Title
Changes in stress
Description
Significant differences among groups in the mean Perceived Stress Scale (PSS) score, which measures the stress severity perceived by the subjects in the last month. The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 40. Higher total scores indicate a worse outcome
Time Frame
At 1 and 3 months
Title
Changes in anxiety
Description
As assessed by the Generalized Anxiety Disorder 7-item Scale
Time Frame
At 1 and 3 months
Title
Changes in fatigue as assessed by EORTC-LQLQ-FA12
Description
12-item multidimensional fatigue questionnaire.The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). The range is 3. For the raw score, less points are considered to have a better outcome.
Time Frame
At 1 and 3 months
Title
Change in functional status
Description
basic assessment of physical activity before diagnosis will be compared to one administered at follow up
Time Frame
At 1 and 3 months
Title
Changes in nutritional behavior before and after intermittent fasting
Description
Will be modeled using a GEE logistic model. Rates of positive nutritional behavior will be compared beween time points.
Time Frame
Up to 5 months
Title
Changes in stress-related biomarkers
Description
Will be evaluated using a linear mixed model and will be used to compare mean levels between timepoints.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years of age Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of: Module A: ECOG 0 - 1 Module B: ECOG 0 - 2 Module C: ECOG 0 - 2 Have a diagnosis of smoldering multiple myeloma or multiple myeloma Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion Are able to understand and follow assessment and intervention procedures Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure MODULE A (PHYSICAL ACTIVITY): Participant has access to a personal computer or tablet with camera, microphone, speakers and internet access MODULE B (NUTRITION): Not applicable MODULE C (BETA BLOCKER): Newly diagnosed patients with multiple myeloma necessitating treatment and before initiation of systemic therapy MODULE C: Female participants of child-bearing potential must have a negative pregnancy test at study entry and then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Male patients with female partners of child-bearing potential should also use adequate contraceptive methods (see above). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Exclusion Criteria: Major comorbidities that would cause danger to the patient when participating in the study and that would have a risk of progression if the patient took part in the study (including, but not limited to): cardiac or pulmonary and infectious diseases (e.g., ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) or, psychiatric illness/social situations that would limit compliance with study requirements Unwilling or unable to follow protocol requirements Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention (comorbidities, myeloma symptoms, treatment side effects) MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system that is deemed to making the patient unsafe to participate. This will be assessed by radiologist, a neurosurgeon and/or an orthopedic surgeon, if applicable. MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system MODULE A (PHYSICAL ACTIVITY): Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced surgeon MODULE B (NUTRITION): Clinical signs of malnutrition (body mass index [BMI] < 18) MODULE B (NUTRITION): Special diets (physician prescribed) MODULE B (NUTRITION): Diabetic treated with glucose-lowering medications and/or insulin MODULE B (NUTRITION): Other reasons not to withhold food MODULE B (NUTRITION): Any condition which in the investigator's opinion deems the participant an unsuitable candidate to limit food consumption MODULE C (BETA BLOCKER): Current use of a beta blocker (includes all non-selective and beta-1 selective blockers) or, use of a beta-blocker within 3 months of study enrollment MODULE C (BETA BLOCKER): Contraindications to the use of beta-blockers, e.g.; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree, uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association [NYHA] Grade III or IV), hypotension ( systolic blood pressure < 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (HbA1C > 8.5 or 12h fasting plasma glucose > 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded MODULE C (BETA BLOCKER): Pregnant or nursing female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Hillengass
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Hillengass
Phone
716-845-3863
Email
jens.hillengass@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Jens Hillengass

12. IPD Sharing Statement

Learn more about this trial

Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma

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