Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma
Launched by ROSWELL PARK CANCER INSTITUTE · Mar 28, 2022
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring new ways to help patients with multiple myeloma, a type of blood cancer, improve their quality of life and boost their immune system without using chemotherapy. The study will look at how activities like exercise and changes in diet can help, as well as how adding a beta-blocker medication called propranolol to standard treatments may affect patients who are newly diagnosed. Previous research has suggested that using a beta-blocker could lead to better survival rates for patients undergoing treatment.
To participate in this trial, you need to be at least 18 years old and have a diagnosis of multiple myeloma or its early form, smoldering multiple myeloma. Participants should be in relatively good health and able to follow study procedures. Those who join can expect to take part in activities related to physical exercise, nutrition, or take the beta-blocker, depending on which part of the study they are assigned to. It’s important to note that certain health conditions may exclude you from participating, so discussing your eligibility with your doctor is essential. Overall, the goal of this trial is to find ways to alleviate symptoms and enhance the well-being of patients living with multiple myeloma.
Gender
ALL
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
- • 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
- 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
- • MODULE D: Cardiovascular disease which is deemed limiting exercise readiness by a cardiologist
About Roswell Park Cancer Institute
Roswell Park Cancer Institute is a leading biomedical research and treatment center dedicated to advancing cancer care through innovative research, education, and patient-centered clinical services. Established in 1898, it is recognized for its pioneering contributions to cancer research and treatment, making significant strides in immunotherapy, precision medicine, and cancer prevention. With a commitment to translating scientific discoveries into effective therapies, Roswell Park conducts a wide range of clinical trials aimed at improving outcomes for cancer patients. Its multidisciplinary team of experts collaborates to provide comprehensive care while fostering an environment of discovery and hope for patients and their families.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Buffalo, New York, United States
Patients applied
Trial Officials
Jens Hillengass
Principal Investigator
Roswell Park Cancer Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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