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

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05312255
Collaborator
(none)
150
1
6
48
3.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral Intervention
  • Behavioral: Behavioral Intervention
  • Drug: Beta-Adrenergic Antagonist
  • Drug: Propranolol
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Other: Resistance Training
  • Other: Resistance Training
  • Other: Short-Term Fasting
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

  2. To assess the effect of gradually increasing physical activity on treatment adherence in patients with multiple myeloma treated with combinations of selinexor compared to a control group. (Selinexor substudy)

SECONDARY OBJECTIVES:
  1. 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.

  2. 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.

  3. To assess the impact of exercise on therapy tolerance in patients treated with Selinexor-based treatment regimens. (Selinexor Substudy)

OUTLINE: Patients are assigned to Module A, B or C. Patients being treated with selinexor-based therapy are assigned to Module A Selinexor Substudy.

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 A SELINEXOR SUBSTUDY: Patients are assigned to 1 of 2 arms.

ARM I: Patients undergo strength training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 3 months. After 3 months, patients then cross-over and complete Arm II intervention.

ARM II: Patients 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 3 months. After 3 months, patients then cross-over and complete Arm I intervention.

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cross-over design in selinexor substudyCross-over design in selinexor substudy
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Improving Host Factors in Patients With Monoclonal Gammopathies
Actual Study Start Date :
Jun 28, 2022
Anticipated Primary Completion Date :
Jun 28, 2025
Anticipated Study Completion Date :
Jun 28, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Module A (strength training, behavioral intervention)

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.

Behavioral: Behavioral Intervention
Wear a FitBit device and receive prompts for 6 months
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Other: Resistance Training
    Undergo strength training for 6 months
    Other Names:
  • Strength Training
  • Experimental: Module B (intermittent fasting)

    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.

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Other: Short-Term Fasting
    Participate in intermittent fasting
    Other Names:
  • Intermittent Fasting
  • Short-term Intermittent Fasting
  • Experimental: Module C Group I (propranolol)

    Patients receive propranolol PO BID for 3 months.

    Drug: Propranolol
    Given PO
    Other Names:
  • 1-[(1-Methylethyl)amino]-3-(1-naphthalenyloxy)-2-propanol
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Active Comparator: Module C Group II (propranolol)

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

    Drug: Beta-Adrenergic Antagonist
    Receive beta-blocker regimen as per SOC
    Other Names:
  • Beta Blocker
  • Beta-Adrenergic Blocking Agent
  • Beta-Blockers
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Experimental: Substudy Arm I (strength training, behavioral intervention)

    Patients undergo strength training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 3 months. After 3 months, patients then cross-over and complete Arm II intervention.

    Behavioral: Behavioral Intervention
    Wear a FitBit device and receive prompts for 3 months
    Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Other: Resistance Training
    Undergo strength training for 3 months
    Other Names:
  • Strength Training
  • Experimental: Substudy Arm II (behavioral intervention, strength training)

    Patients 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 3 months. After 3 months, patients then cross-over and complete Arm I intervention.

    Behavioral: Behavioral Intervention
    Wear a FitBit device and receive prompts for 3 months
    Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Other: Resistance Training
    Undergo strength training for 3 months
    Other Names:
  • Strength Training
  • Outcome Measures

    Primary Outcome Measures

    1. Changes in immune cell subsets [At baseline and at 1 year]

      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).

    2. Adherence rate (Selinexor Substudy) [At baseline, 3 and 6 months]

      proportion of patients without clinical or serological progression remaining on study at 3 and 6 monthswho achieved ≥ 80% of physical exercise targets.

    Secondary Outcome Measures

    1. Changes in the gut microbiome [At 1 and 3 months]

      Fecal samples will be collected and compared from group with physical exercise,compared to group doing intermittent fasting).

    2. Comparison in bone markers [At 1 and 3 months]

      Will be assessed from intermittent fasting serum samples compared to serum samples of those doing physical exercise.

    3. Changes in body composition [3 months]

      Dexa (bone density scan) will be performed at 1 and 3 months

    4. Changes in stress [At 1 and 3 months]

      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

    5. Changes in anxiety [At 1 and 3 months]

      As assessed by the Generalized Anxiety Disorder 7-item Scale

    6. Changes in fatigue as assessed by EORTC-LQLQ-FA12 [At 1 and 3 months]

      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.

    7. Change in functional status [At 1 and 3 months]

      basic assessment of physical activity before diagnosis will be compared to one administered at follow up

    8. Changes in nutritional behavior before and after intermittent fasting [Up to 5 months]

      Will be modeled using a GEE logistic model. Rates of positive nutritional behavior will be compared beween time points.

    9. Changes in stress-related biomarkers [Up to 6 months]

      Will be evaluated using a linear mixed model and will be used to compare mean levels between timepoints.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Principal Investigator: Jens Hillengass, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT05312255
    Other Study ID Numbers:
    • I 1680221
    • NCI-2022-01918
    • I 1680221
    First Posted:
    Apr 5, 2022
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 1, 2022
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 6, 2022