Plasma Cell MyelomaNCT03793907
Strength Training in Improving Pain and Quality of Life in Patients With Multiple Myeloma
A study testing FitBit, Quality-of-Life Assessment and Questionnaire Administration in people with Plasma Cell Myeloma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- FitBit, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2019to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Feasibility of Strength Training and Impact on Pain and Quality of Life in Patients With Multiple Myeloma
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.
Read the 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:
- 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:
- 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.
- Conditions
- Plasma Cell Myeloma
- Being tested
- FitBit, Quality-of-Life Assessment, Questionnaire Administration, Resistance Training, STEPS to Enhance Physical Activity
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitBitDevice
Wear Fitbit
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Resistance TrainingOther
Also called Strength Training
Complete strength training
STEPS to Enhance Physical ActivityBehavioural
Also called STEPS, STEPS Intervention, STEPS to Enhance Physical Activity (STEPS)
Complete a walking program
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2 (walking program) | Active comparator | 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. Receives: Device: FitBit; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: STEPS to Enhance Physical Activity |
| Cohort 1 (strength training) | Experimental | 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 BID up to 52 sessions for 6 months. Receives: Device: FitBit; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility rate
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.
Measured: At 6 months
Secondary outcomes (2)
Adherence rate (Cohort 1)
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.
Measured: At 6 months
Adherence rate (Cohort 2)
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.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start17 Dec 2019
- Primary completion28 Feb 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Hillengass, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793907
- Sponsor's protocol ID
- i 70118
- Other IDs
- i 70118
- Status last verified
- Apr 2023
- First submitted
- 28 Dec 2018
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Strength Training and Impact on Pain and Quality of Life in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03793907
- Acronym / sponsor ID
- i 70118
- Conditions
- Plasma Cell Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 (walking program) | Active comparator | Device: FitBit, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Behavioral: STEPS to Enhance Physical ActivityPatients 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. |
| Cohort 1 (strength training) | Experimental | Device: FitBit, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Resistance TrainingPatients receive a Fitbit to track their physical activity, and complete an in-person personalized and supervised full-body strength training program over 1 hour BID up to 52 sessions for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitBitWear Fitbit | Device | Cohort 1 (strength training), Cohort 2 (walking program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Cohort 1 (strength training), Cohort 2 (walking program) |
| Questionnaire AdministrationAncillary studies | Other | Cohort 1 (strength training), Cohort 2 (walking program) |
| Resistance TrainingAlso: Strength TrainingComplete strength training | Other | Cohort 1 (strength training) |
| STEPS to Enhance Physical ActivityAlso: STEPS, STEPS Intervention, STEPS to Enhance Physical Activity (STEPS)Complete a walking program | Behavioural | Cohort 2 (walking program) |
Primary outcome
Feasibility rate
Time frame: 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.
2 secondary outcomes
Adherence rate (Cohort 1)
Time frame: At 6 months
Adherence rate (Cohort 2)
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Hillengass principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitBit, Quality-of-Life Assessment and Questionnaire Administration in people with Plasma Cell Myeloma, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility rate (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.