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New treatment option for Plasma Cell Myeloma
Official title Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma
ClinicalTrials.gov ID: NCT05312255
What this study is testing
What is Beta-Adrenergic Antagonist?
Beta-Adrenergic Antagonist is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for plasma cell myeloma.
Also referred to as Beta Blocker, Beta-Adrenergic Blocking Agent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system that...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- MODULE D: Cardiovascular disease which is deemed limiting exercise readiness by a cardiologist
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.