Plasma Cell MyelomaNCT04100044
Exercise Prescription for the Improvement of Quality of Life in Elderly Patients With Multiple Myeloma
A study testing Exercise Counseling, Exercise Intervention and Questionnaire administration in people with Plasma Cell Myeloma, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This trial studies how well exercise prescription works in improving quality of life in elderly patients with multiple myeloma. Engaging and adhering to an exercise program may improve functional status and quality of life and decrease pain and skeletal-related events. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- Exercise Counseling, Exercise Intervention and Questionnaire administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 27 May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of multiple myeloma
- If patients are undergoing an autologous stem cell transplant, then they will be enrolled after their transplant so that there is not an interruption in the study period
- Patients are eligible whether or not they have lytic bone lesions
- If they do have lytic lesions, the lesions must be low risk for fracture (low risk by Mirel's score or less than 50% of vertebral body height)
- If patients are high risk for bone fracture, they must undergo bone stabilization prior to being considered for enrollment
- Patients will have to be at least 6 weeks from date of stabilization
Show all 12Show fewer
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Subjects need to be within 24 months of their multiple myeloma diagnosis
- Subject must be able to stand and walk to perform baseline assessments
- Subjects must be able to text message (will need cell phone)
- Need to limit to able to read and understand English as video visit capability is only in English at this point in time and multiple questionnaires will not be translated into other languages
Who cannot join
- Presence of lytic lesions that cannot undergo appropriate stabilization
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
- Non English speaking
- Diagnosed greater than 24 months prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Pilot Study to Assess Adherence of an Exercise Prescription in Elderly Multiple Myeloma Patients
This trial studies how well exercise prescription works in improving quality of life in elderly patients with multiple myeloma. Engaging and adhering to an exercise program may improve functional status and quality of life and decrease pain and skeletal-related events. This study is being done to see if elderly patients with multiple myeloma can participate in a physical activity program.
Read the detailed description
PRIMARY OBJECTIVE:
- Assess the ability for elderly multiple myeloma patients to maintain a personalized exercise regimen and activity level for a period of 6 months.
SECONDARY OBJECTIVE:
- Assess changes in biometric data.
EXPLORATORY OBJECTIVE I. Evaluate changes in bone metabolism markers as a result of exercise.
OUTLINE:
Patients meet with a physical therapist on day 0 and at 3 and 6 months and receive a personalized home exercise intervention consisting of aerobic and resistance training for 6 months. Patients also receive face-to-face sessions, video chats, or text message check-ins with physical therapist weekly for 6 weeks and then every other week for up to 24 weeks.
After completion of study, patients are followed up every 6 months for 5 years.
- Conditions
- Plasma Cell Myeloma
- Being tested
- Exercise Counseling, Exercise Intervention, Questionnaire administration, Quality-of-Life Assessment
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise CounselingOther
Meet with physical therapist
Exercise InterventionBehavioural
Receive personalized home exercise intervention
Questionnaire administrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Health Services Research (physical therapist, exercise) | Experimental | Patients meet with a physical therapist on day 0 and at 3 and 6 months and receive a personalized home exercise intervention consisting of aerobic and resistance training for 6 months. Patients also receive face-to-face sessions, video chats, or text message check-ins with physical therapist weekly for 6 weeks and then every other week for up to 24 weeks. Receives: Other: Exercise Counseling; Behavioral: Exercise Intervention; Other: Questionnaire administration; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity adherence
Will be measured at each assessment using an Actigraph tri-axial hip-worn accelerometers, worn for 7 days at each assessment point, supplemented with patient self-report of exercise in the past 7 days using a physical activity recall to differentiate subtypes of physical activity. Will estimate the proportion of participants who maintained their target level, along with an exact 95% confidence interval. We will use an exact binomial test to assess whether adherence exceeds 50%. Adherence to the exercise prescriptions will be measured with the absolute and relative increase from baseline in min/week of aerobic and resistance exercise at 3 months and 6 months (benchmark: min/week of exercise changes by > 100% and a minimum of 90 min/week at 6 months). The percent of prescribed minutes of exercise performed at 3 and 6 months also will be calculated with goal of adherence greater than 50%.
Measured: Up to 6 months
Retention
Will be measured by percent number of days the patient wears the provided FitBit during the 6-month period.
Measured: Up to 6 months
Secondary outcomes (5)
Change in short physical performance battery protocol
The Short Physical Performance Battery Protocol is a test consisting of three sections (Balance, Gait Speed, and Chair Stand). The score for the Short Physical Performance Battery Protocol is scored as a total of the points earned in each section. Scores range from a total of 0 to 12 points.
Will use methods for paired data to estimate the mean difference, along with a 95% confidence interval. Will carry out additional analyses to assess the change of these outcomes over time, utilizing the repeated measurements obtained at all timepoints. Will use mixed-effects regression for all analyses.
Measured: Baseline up to 6 months
Change in 6 minute walk test
Will use methods for paired data to estimate the mean difference, along with a 95% confidence interval. Will carry out additional analyses to assess the change of these outcomes over time, utilizing the repeated measurements obtained at all timepoints. Will use mixed-effects regression for all analyses.
Measured: Baseline up to 6 months
Change in grip strength
Grip strength will be measured using a dynamometer, which gives results in kg of force. Will use methods for paired data to estimate the mean difference, along with a 95% confidence interval. Will carry out additional analyses to assess the change of these outcomes over time, utilizing the repeated measurements obtained at all timepoints. Will use mixed-effects regression for all analyses.
Measured: Baseline up to 6 months
Change in Mini-Balance Evaluation Systems Test
Will use methods for paired data to estimate the mean difference, along with a 95% confidence interval. Will carry out additional analyses to assess the change of these outcomes over time, utilizing the repeated measurements obtained at all timepoints. Will use mixed-effects regression for all analyses.
Measured: Baseline up to 6 months
Change in frailty score
Will use methods for paired data to estimate the mean difference, along with a 95% confidence interval. Will carry out additional analyses to assess the change of these outcomes over time, utilizing the repeated measurements obtained at all timepoints. Will use mixed-effects regression for all analyses.
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start24 Oct 2019
- Primary completion27 May 2022
- Study completion27 May 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 Thomas Jefferson UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Binder, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100044
- Sponsor's protocol ID
- 19G.514
- Other IDs
- JT 13791
- Status last verified
- Apr 2025
- First submitted
- 4 Sep 2019
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Adherence of an Exercise Prescription in Elderly Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT04100044
- Acronym / sponsor ID
- 19G.514
- Conditions
- Plasma Cell Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 23 Sep 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 exercise prescription works in improving quality of life in elderly patients with multiple myeloma. Engaging and adhering to an exercise program may improve functional status and quality of life and decrease pain and skeletal-related events. This study is being done to see if elderly patients with multiple myeloma can participate in a physical activity program.
Detailed description
PRIMARY OBJECTIVE:
- Assess the ability for elderly multiple myeloma patients to maintain a personalized exercise regimen and activity level for a period of 6 months.
SECONDARY OBJECTIVE:
- Assess changes in biometric data.
EXPLORATORY OBJECTIVE I. Evaluate changes in bone metabolism markers as a result of exercise.
OUTLINE:
Patients meet with a physical therapist on day 0 and at 3 and 6 months and receive a personalized home exercise intervention consisting of aerobic and resistance training for 6 months. Patients also receive face-to-face sessions, video chats, or text message check-ins with physical therapist weekly for 6 weeks and then every other week for up to 24 weeks.
After completion of study, patients are followed up every 6 months for 5 years.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Services Research (physical therapist, exercise) | Experimental | Other: Exercise Counseling, Behavioral: Exercise Intervention, Other: Questionnaire administration, Other: Quality-of-Life AssessmentPatients meet with a physical therapist on day 0 and at 3 and 6 months and receive a personalized home exercise intervention consisting of aerobic and resistance training for 6 months. Patients also receive face-to-face sessions, video chats, or text message check-ins with physical therapist weekly for 6 weeks and then every other week for up to 24 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Diagnosis of multiple myeloma
- If patients are undergoing an autologous stem cell transplant, then they will be enrolled after their transplant so that there is not an interruption in the study period
- Patients are eligible whether or not they have lytic bone lesions
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (4 listed)
- Presence of lytic lesions that cannot undergo appropriate stabilization
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
- Non English speaking
- Diagnosed greater than 24 months prior to screening
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 |
|---|---|---|
| Exercise CounselingMeet with physical therapist | Other | Health Services Research (physical therapist, exercise) |
| Exercise InterventionReceive personalized home exercise intervention | Behavioural | Health Services Research (physical therapist, exercise) |
| Questionnaire administrationAncillary studies | Other | Health Services Research (physical therapist, exercise) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Health Services Research (physical therapist, exercise) |
Primary outcome
Physical activity adherence
Time frame: Up to 6 months
Will be measured at each assessment using an Actigraph tri-axial hip-worn accelerometers, worn for 7 days at each assessment point, supplemented with patient self-report of exercise in the past 7 days using a physical activity recall to differentiate subtypes of physical activity. Will estimate the proportion of participants who maintained their target level, along with an exact 95% confidence interval. We will use an exact binomial test to assess whether adherence exceeds 50%. Adherence to the exercise prescriptions will be measured with the absolute and relative increase from baseline in min/week of aerobic and resistance exercise at 3 months and 6 months (benchmark: min/week of exercise changes by > 100% and a minimum of 90 min/week at 6 months). The percent of prescribed minutes of exercise performed at 3 and 6 months also will be calculated with goal of adherence greater than 50%.
Retention
Time frame: Up to 6 months
Will be measured by percent number of days the patient wears the provided FitBit during the 6-month period.
5 secondary outcomes
Change in short physical performance battery protocol
Time frame: Baseline up to 6 months
Change in 6 minute walk test
Time frame: Baseline up to 6 months
Change in grip strength
Time frame: Baseline up to 6 months
Change in Mini-Balance Evaluation Systems Test
Time frame: Baseline up to 6 months
Change in frailty score
Time frame: Baseline up to 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 29 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Adam Binder, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Counseling, Exercise Intervention and Questionnaire administration in people with Plasma Cell Myeloma, run by Thomas Jefferson University 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 12 inclusion and 4 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 29 Apr 2025. 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?
Physical activity adherence (time frame: Up to 6 months). The study lists 2 primary outcomes in all. 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 29 Apr 2025.