Plasma Cell Myeloma
Conditions
Brief summary
This trial studies how well strength training works in improving bone health, pain, and quality of life in patients with multiple myeloma. Weekly physical activity may improve bone recovery, reduce pain, and increase quality of life in patients with multiple myeloma.
Detailed description
PRIMARY OBJECTIVES: * I. To assess the feasibility of a 6 month, twice weekly supervised strength training intervention in patients with multiple myeloma. (Cohort 1) * II. To assess the feasibility of a 6 month behavioral intervention to prompt an increase in weekly physical activity in patient with multiple myeloma. (Cohort 2) SECONDARY OBJECTIVES: I. To assess the adherence rate of patients during a 6 month intervention program. II. To assess the eligibility and recruitment rate for the trial among patients with multiple myeloma. EXPLORATORY OBJECTIVES: I. Comparison of disease activity parameters, physical activity level, clinical symptoms, medication, psycho-oncological parameters before, during and after intervention. II. Determine factors that may influence a persons' willingness to participate in the trial. III. Investigate immune fitness by frequencies and function of immune cell subsets in peripheral blood. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHRT 1 (STRENGTH TRAINING): Patients receive a Fitbit to track their physical activity, and complete an in-person personalized and supervised full-body strength training program over 1 hour twice weekly (BID) up to 52 sessions for 6 months. COHORT 2 (BEHAVIORAL INTERVENTION): Patients receive a Fitbit to track their physical activity, and complete an unsupervised walking program daily at home, increasing physical activity stepwise weekly, for 6 months. After completion of study, patients are followed up every 3 months for 1 year.
Interventions
DEVICEFitBit
Wear Fitbit
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
OTHERResistance Training
Complete strength training
BEHAVIORALSTEPS to Enhance Physical Activity
Complete a walking program
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 * Have a diagnosis of 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 training procedures * Participant or legal representative 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
* Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system * Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced neuro- and spine surgeon * Major comorbidities that would cause danger to the patient when participating in the study. Examples are cardiac or pulmonary and infectious diseases that would have a risk of progression if the patient took part in the study * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility rate | At 6 months | Will be defined as the proportion of enrolled patients who are still on study at the end of 6 months. Analysis will be done via computing a two-sided 95% confidence interval for the true proportion using Clopper-Pearson method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence rate (Cohort 1) | At 6 months | Will be defined as the proportion of patients remaining on study at 6 months who complete \>= 80% of the intervention activities. Analysis will be done via computing a two-sided 95% confidence interval for the true proportion using Clopper-Pearson method. |
| Adherence rate (Cohort 2) | At 6 months | Will be defined as the proportion of patients whose average daily step counts each week are at or above their goal for that week at least 20/26 weeks, or 80% of the weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain | Before and after strength training program up to 1 year | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. |
| Polyneuropathy | Before and after strength training program up to 1 year | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. |
| Opioid and other drug consumption | Before and after strength training program up to 1 year | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. |
| Differences in lab parameters | Before and after strength training program up to 1 year | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. |
| Fatigue | Before, during and after strength training program | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. |
| Reasons why patients do not participate in the trial | Before and after strength training program up to 1 year | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. This will be assessed by analysis of the screening questionnaires and the checklist. |
| Immune fitness frequencies and function of immune cell subsets | Before and after strength training program up to 1 year | Will be measured in peripheral blood. Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. This will be assessed by analysis of the screening questionnaires and the checklist. |
| Psycho-oncological parameters | Before and after strength training program up to 1 year | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. |
| Clinical performance | Before and after strength training program up to 1 year | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. |
| Physical activity level | Before and after strength training program up to 1 year | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. |
Countries
United States
Outcome results
None listed