RECRUITING

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

Conditions

Plasma Cell Myeloma Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Smoldering Plasma Cell Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial investigates the effect of non-chemotherapeutic interventions in patients with multiple myeloma or MDS. 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.

Official Title

Improving Host Factors in Patients With Monoclonal Gammopathies and Other Hematologic Disorders

Quick Facts

Study Start:2022-06-28

Study Completion:2027-06-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05312255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * Module D: ECOG 0-1 * MODULE A, B and C: Have a diagnosis of smoldering multiple myeloma, multiple myeloma or plasma cell leukemia (PCL) or * MODULE D: non transfusion dependent low-risk MDS * 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 and D (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 MODULE D: Patients with MDS not necessitating transfusion therapy at time of enrollment (no transfusion within 8 weeks prior to enrollment) i.e. patients on observation, or receiving growth factors or luspatercept only	* 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 * MODULE D: Cardiovascular disease which is deemed limiting exercise readiness by a cardiologist

Inclusion Criteria

Exclusion 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
* Module D: ECOG 0-1
* MODULE A, B and C: Have a diagnosis of smoldering multiple myeloma, multiple myeloma or plasma cell leukemia (PCL) or
* MODULE D: non transfusion dependent low-risk MDS
* 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 and D (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 MODULE D: Patients with MDS not necessitating transfusion therapy at time of enrollment (no transfusion within 8 weeks prior to enrollment) i.e. patients on observation, or receiving growth factors or luspatercept only

* 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
* MODULE D: Cardiovascular disease which is deemed limiting exercise readiness by a cardiologist

Contacts and Locations

Principal Investigator

Jens Hillengass

PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Study Locations (Sites)

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

Jens Hillengass, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-28

Study Completion Date2027-06-28

Study Record Updates

Study Start Date2022-06-28

Study Completion Date2027-06-28

Terms related to this study

Additional Relevant MeSH Terms

Plasma Cell Myeloma
Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma
Smoldering Plasma Cell Myeloma