Multiple MyelomaNCT06061302
Multiple Myeloma Yoga Pilot Study
A study testing Immediate yoga intervention and Delayed yoga intervention in people with Multiple Myeloma, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility of implementing a weekly yoga intervention in patients with multiple myeloma on active therapy. This study aims to analyze the impact of yoga intervention on physical symptoms (e.g. pain, fatigue, sleep), psychological symptoms (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Immediate yoga intervention and Delayed yoga intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 16 Jul 2025
- 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
- Any adult of age 18 and above
- Able to understand basic English
- Able to provide informed consent
- Diagnosis of multiple myeloma on active treatment as determined by investigators
- Good performance status as defined by European Cooperative Oncology Group score 0-1
- Able to utilize computer/laptop and smart phone
- Able and willing to travel to the yoga studio for weekly sessions
- Able to utilized a wearable device, such as Apple Watch or Fitbit (optional)
Who cannot join
- Poor performance status with European Cooperative Oncology Group score 2-4
- Actively participating in another clinical trial
- Poorly controlled mental health symptoms as determined by treating physician
- Reported fall or syncope in the last 2 months prior to enrollment
- Concurrent diagnosis of amyloidosis or other cancer requiring active treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Cancer Center
Tucson, Arizona, 85719
About this study
Official title: A Randomized Pilot Study of Yoga Intervention in Patients With Multiple Myeloma on Active Therapy
The purpose of this study is to evaluate the feasibility of implementing a weekly yoga intervention in patients with multiple myeloma on active therapy. This study aims to analyze the impact of yoga intervention on physical symptoms (e.g. pain, fatigue, sleep), psychological symptoms (e.g. anxiety, depression), and overall health-related quality of life (HRQOL) in multiple myeloma patients on active treatment.
- Conditions
- Multiple Myeloma
- Being tested
- Immediate yoga intervention, Delayed yoga intervention
- Keywords
- Multiple Myeloma, yoga
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate yoga interventionOther
Subjects will complete 12 consecutive weeks of weekly 40 minute guided mindful yoga weeks 1-12.
Delayed yoga interventionOther
Subjects will complete 12 consecutive weeks of weekly 40 minute guided mindful yoga weeks 13-24.
| Study group | Role | What they receive |
|---|---|---|
| Immediate yoga group | Experimental | 20 participants randomized to immediate yoga intervention group will participate together in a weekly 40-minute guided mindful yoga intervention for a total of 12 consecutive weeks. After each session, participants will be asked to complete the Edmonton Symptom Assessment System (ESAS-r) through MyDataHelps app. At the end of each session, participants will be asked additional questions via MyDataHelps such as completion of yoga session on-site or remotely, the length of time they participated in the session, any additional yoga sessions during the past week, and comments regarding the session/intervention. These participants will also complete health-related quality of life (HRQOL) assessment (EORTC QLQ-C30) at baseline, 6 weeks, and 12 weeks during active yoga intervention. Receives: Other: Immediate yoga intervention |
| Waitlist yoga group (delayed yoga intervention group) | Active comparator | 20 participants randomized to this group will start the yoga intervention at week 13 and participate in 12 consecutive weeks of weekly 40 minute guided mindful yoga. Participants in this group will complete ESAS-r every 3 weeks and EORTC QLQ-C30 every 6 weeks for the first 12 weeks. These participants will also complete HRQOL assessment (EORTC QLQ-C30) at baseline, 6 weeks, and 12 weeks during active yoga intervention, weeks 13-24. Receives: Other: Delayed yoga intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate of weekly yoga intervention
Evaluate the feasibility of implementing a weekly 40-minute yoga intervention in patients with multiple myeloma on active treatment for 12 weeks by measuring compliance and overall completion rate of the program.
Measurement: Compliance will be measured by overall percentage of patients completing 40 minutes of weekly yoga sessions in at least 8 out of 12 weeks of intervention. Completion rate will be measured by overall percentage of patients completing the 12 weeks of intervention without withdrawing or dropping out from the study.
Hypothesis: Implementation of a weekly mindful yoga intervention will be feasible in multiple myeloma patients as demonstrated compliance of at least 70% patients completing 40 minutes of weekly yoga sessions in 8 out of 12 weeks of intervention.
Measured: 12 weeks
Accrual rate of yoga intervention study
Evaluate the feasibility of implementing a weekly 40-minute yoga intervention in patients with multiple myeloma on active treatment for 12 weeks by measuring accrual rate.
Measurement: Accrual rate will be measured by overall percentage of participants enrolled in the study at the end of 3-month accrual period compared to goal accrual of total 40 participants.
Hypothesis: Implementation of a weekly yoga intervention will be feasible in multiple myeloma patients as demonstrated by accrual of 40 patients (100%) over 3 months.
Measured: 12 weeks
Secondary outcomes (4)
Short-term impact of yoga intervention on symptom burden
Evaluate the short-term impact of weekly yoga intervention in patients with multiple myeloma on active treatment on symptom burden by measuring Edmonton Symptom Assessment System (ESAS-r) after each session weekly.
Measurement: Patient-reported scores will be measured after 40-minute yoga intervention each week using ESAS-r and they will be compared to baseline. Symptom assessment scale ranges from 0 (best) to 10 (worst).
Hypothesis: Patients with multiple myeloma on active treatment will have statistically significant improvement in symptom burden compared to baseline after 40-minute yoga intervention each week.
Measured: 12-weeks
Short-term impact of yoga intervention on health-related quality of life (HRQOL)
Evaluate the impact of a weekly 12-week yoga intervention program in patients with multiple myeloma on active treatment on health-related quality of life (HRQOL) over 12 weeks by measuring HRQOL questionnaire, European Organization For Research and Treatment Of Cancer-Core Quality of Life Questionnaire (EORTC QLQ-C30), responses at baseline, 6 and 12 weeks.
Measurement: Overall health-related quality of life in participants will be measured at baseline, 6 and 12 weeks using EORTC QLQ-C30 assessment tool and scores will be compared to baseline. Scores range from 0 to 100 with higher numbers indicating higher function and quality of life. Subscale for symptom burden will indicate higher symptom burden with higher score values. Hypothesis: Patients with multiple myeloma on active treatment will have statistically significant improvement in HRQOL scores (measured by EORTC QLQ-C30) at 6 and 12 weeks compared to baseline and controls due to 12-week mindful yoga intervention.
Measured: 12-weeks
Short-term impact of yoga intervention on total daily activity
Evaluate the impact of a 12-week mindful yoga intervention program in patients with multiple myeloma on active treatment on total daily activity measured by total daily steps using wearable device (FitBit).
Measurement: Total daily steps will be measured in each participant using a wearable device (FitBit), and mean values from each week will be compared at baseline, 6 weeks, and 12 weeks.
Hypothesis: Patients with multiple myeloma on active treatment undergoing yoga intervention will have increased total daily activity (daily steps) at 6 weeks and 12 weeks.
Measured: 12-weeks
Short-term impact of yoga intervention on resting heart rate
Evaluate the impact of a 12-week mindful yoga intervention program in patients with multiple myeloma on active treatment on resting heart rate using wearable device (FitBit).
Measurement: Resting heart rate will be measured in each participant using a wearable device (FitBit), and mean resting heart rate values from each week will be compared at baseline, 6 weeks, and 12 weeks.
Hypothesis: Patients with multiple myeloma on active treatment undergoing yoga intervention will have decreased resting heart rate at 6 weeks and 12 weeks.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start15 Nov 2023
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaunak Pandya, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061302
- Sponsor's protocol ID
- STUDY00003083
- Status last verified
- Jul 2025
- First submitted
- 29 Aug 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study of Yoga Intervention in Patients With Multiple Myeloma on Active Therapy
- ClinicalTrials.gov ID
- NCT06061302
- Acronym / sponsor ID
- STUDY00003083
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 29 Sep 2023 (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.
The purpose of this study is to evaluate the feasibility of implementing a weekly yoga intervention in patients with multiple myeloma on active therapy. This study aims to analyze the impact of yoga intervention on physical symptoms (e.g. pain, fatigue, sleep), psychological symptoms (e.g. anxiety, depression), and overall health-related quality of life (HRQOL) in multiple myeloma patients on active treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate yoga group | Experimental | Other: Immediate yoga intervention20 participants randomized to immediate yoga intervention group will participate together in a weekly 40-minute guided mindful yoga intervention for a total of 12 consecutive weeks. After each session, participants will be asked to complete the Edmonton Symptom Assessment System (ESAS-r) through MyDataHelps app. At the end of each session, participants will be asked additional questions via MyDataHelps such as completion of yoga session on-site or remotely, the length of time they participated in the session, any additional yoga sessions during the past week, and comments regarding the session/intervention. These participants will also complete health-related quality of life (HRQOL) assessment (EORTC QLQ-C30) at baseline, 6 weeks, and 12 weeks during active yoga intervention. |
| Waitlist yoga group (delayed yoga intervention group) | Active comparator | Other: Delayed yoga intervention20 participants randomized to this group will start the yoga intervention at week 13 and participate in 12 consecutive weeks of weekly 40 minute guided mindful yoga. Participants in this group will complete ESAS-r every 3 weeks and EORTC QLQ-C30 every 6 weeks for the first 12 weeks. These participants will also complete HRQOL assessment (EORTC QLQ-C30) at baseline, 6 weeks, and 12 weeks during active yoga intervention, weeks 13-24. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Any adult of age 18 and above
- Able to understand basic English
- Able to provide informed consent
- Diagnosis of multiple myeloma on active treatment as determined by investigators
- Good performance status as defined by European Cooperative Oncology Group score 0-1
Key exclusion criteria (5 listed)
- Poor performance status with European Cooperative Oncology Group score 2-4
- Actively participating in another clinical trial
- Poorly controlled mental health symptoms as determined by treating physician
- Reported fall or syncope in the last 2 months prior to enrollment
- Concurrent diagnosis of amyloidosis or other cancer requiring active treatment
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 |
|---|---|---|
| Immediate yoga interventionSubjects will complete 12 consecutive weeks of weekly 40 minute guided mindful yoga weeks 1-12. | Other | Immediate yoga group |
| Delayed yoga interventionSubjects will complete 12 consecutive weeks of weekly 40 minute guided mindful yoga weeks 13-24. | Other | Waitlist yoga group (delayed yoga intervention group) |
Primary outcome
Compliance rate of weekly yoga intervention
Time frame: 12 weeks
Evaluate the feasibility of implementing a weekly 40-minute yoga intervention in patients with multiple myeloma on active treatment for 12 weeks by measuring compliance and overall completion rate of the program. Measurement: Compliance will be measured by overall percentage of patients completing 40 minutes of weekly yoga sessions in at least 8 out of 12 weeks of intervention. Completion rate will be measured by overall percentage of patients completing the 12 weeks of intervention without withdrawing or dropping out from the study. Hypothesis: Implementation of a weekly mindful yoga intervention will be feasible in multiple myeloma patients as demonstrated compliance of at least 70% patients completing 40 minutes of weekly yoga sessions in 8 out of 12 weeks of intervention.
Accrual rate of yoga intervention study
Time frame: 12 weeks
Evaluate the feasibility of implementing a weekly 40-minute yoga intervention in patients with multiple myeloma on active treatment for 12 weeks by measuring accrual rate. Measurement: Accrual rate will be measured by overall percentage of participants enrolled in the study at the end of 3-month accrual period compared to goal accrual of total 40 participants. Hypothesis: Implementation of a weekly yoga intervention will be feasible in multiple myeloma patients as demonstrated by accrual of 40 patients (100%) over 3 months.
4 secondary outcomes
Short-term impact of yoga intervention on symptom burden
Time frame: 12-weeks
Short-term impact of yoga intervention on health-related quality of life (HRQOL)
Time frame: 12-weeks
Short-term impact of yoga intervention on total daily activity
Time frame: 12-weeks
Short-term impact of yoga intervention on resting heart rate
Time frame: 12-weeks
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 20 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Shaunak Pandya, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate yoga intervention and Delayed yoga intervention in people with Multiple Myeloma, run by University of Arizona 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 8 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 20 Jul 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?
Compliance rate of weekly yoga intervention (time frame: 12 weeks). 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 20 Jul 2025; AzTrials last refreshed its copy on 4 Nov 2026.