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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05312255
Recruitment Status : Recruiting
First Posted : April 5, 2022
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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
Plasma Cell Myeloma Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Smoldering Plasma Cell Myeloma Behavioral: Behavioral Intervention Drug: Beta-Adrenergic Antagonist Drug: Propranolol Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Resistance Training Other: Short-Term Fasting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cross-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 : June 28, 2022
Estimated Primary Completion Date : June 28, 2025
Estimated Study Completion Date : June 28, 2026


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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Resistance Training
Undergo strength training for 6 months
Other Name: 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 Name: 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 Name: 1-[(1-Methylethyl)amino]-3-(1-naphthalenyloxy)-2-propanol

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: 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 Name: 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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Resistance Training
Undergo strength training for 3 months
Other Name: 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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Resistance Training
Undergo strength training for 3 months
Other Name: Strength Training




Primary Outcome Measures :
  1. Changes in immune cell subsets [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months ]
    Dexa (bone density scan) will be performed at 1 and 3 months

  4. Changes in stress [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 6 months ]
    Will be evaluated using a linear mixed model and will be used to compare mean levels between timepoints.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05312255


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Jens Hillengass    716-845-3863    jens.hillengass@roswellpark.org   
Principal Investigator: Jens Hillengass         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
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Principal Investigator: Jens Hillengass Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT05312255    
Other Study ID Numbers: I 1680221
NCI-2022-01918 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 1680221 ( Other Identifier: Roswell Park Cancer Institute )
First Posted: April 5, 2022    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: July 2022

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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:
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Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Precancerous Conditions
Hypergammaglobulinemia
Propranolol
Adrenergic beta-Antagonists
Adrenergic Agents
Adrenergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents