Multiple Myeloma Clinical Trial

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

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.

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Full 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.

II. 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:

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.

III. 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.

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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 (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

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

150

Study ID:

NCT05312255

Recruitment Status:

Recruiting

Sponsor:

Roswell Park Cancer Institute

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Jens Hillengass
Contact
716-845-3863
[email protected]
Jens Hillengass
Principal Investigator

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Study is for people with:

Multiple Myeloma

Estimated Enrollment:

150

Study ID:

NCT05312255

Recruitment Status:

Recruiting

Sponsor:


Roswell Park Cancer Institute

How clear is this clinincal trial information?

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