Multiple MyelomaNCT05706766
Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
A study testing PARE in people with Multiple Myeloma and Stem Cell Transplant Complications, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training program implemented 8 weeks prior to receiving autologous stem cell transplant (ASCT) for multiple myeloma participants will improve muscular strength, physical capacity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Stem Cell Transplant Complications
- What is being tested?
- PARE
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jun 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Over 18 years old.
- All patients will have a diagnosis of multiple myeloma, referral to DFCI transplant team, and assigned to the autologous transplantation waiting list for a first transplant.
- Planning to receive autologous stem cell transplant after 8 weeks with or without concurrent neoadjuvant treatments at Dana-Farber Cancer Institute.
- Medical clearance to perform moderate-vigorous intensity aerobic and resistance exercise intervention and fitness testing by their treating physician or a certified clinical exercise physiologist.
- Speak English.
- Currently participate in less than or equal to 60 minutes of structured moderate-vigorous intensity exercise/week.
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- Willing to travel to Dana-Farber Cancer Institute for necessary data collection.
- Ability to understand and the willingness to sign a written informed consent document.
- The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
Who cannot join
- History of unstable angina, abnormal resting ECG and/or unstable angina or a heart attack in the previous month to allow safe completion of the cardiopulmonary exercise test (CPET) or VO2peak test.
- Patients with known spinal instability, spinal cord compression or neurological deficits or contraindications that preclude exercise.
- Those who have had recent (within six weeks) spinal surgery or other intervention surgery for pathological fractures.
- Those deemed unsuitable to partake by the transplant or study team.
- Patients at high-risk of impending pathologic fracture of a weight-bearing bone (including spine, hip/femur and humerus) as determined by physician.
- Unable or unwilling to undertake an exercise program on a regular basis.
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- Pre-existing musculoskeletal or cardiorespiratory disease, or metabolic diseases that could exacerbate with exercise, in addition to other conditions deemed unsafe by physician.
- Patients with other active malignancies requiring active therapy.
- Participate in more than 60 minutes of structured moderate to vigorous intensity exercise/week.
- Unable to travel to Dana-Farber Cancer Institute for necessary data collection.
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Christina Dieli-Conwright, PhD, MPH, 617-632-3800, ChristinaM_Dieli-Conwright@dfci.harvard.edu
Christina Dieli-Conwright, PhD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Christina Dieli-Conwright, christinam_dieli-conwright@dfci.harvard.edu
About this study
Official title: Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial
The goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training program implemented 8 weeks prior to receiving autologous stem cell transplant (ASCT) for multiple myeloma participants will improve muscular strength, physical capacity, patient reported outcomes, and cardiometabolic health outcomes.
The names of the study interventions involved in this study are:
- Prehabilitative aerobic and resistance exercise (PARE) (virtually supervised 8-week aerobic and resistance exercise program)
- Waitlist control (8-week normal activity behavior)
Read the detailed description
This is a single-center, prospective, parallel-group, randomized controlled study that will enroll patients diagnosed with multiple myeloma planning to receive autologous stem cell transplant (ASCT).
Participants will be randomized into one of the intervention groups: Exercise Group (PARE) versus Waitlist Control Group. Randomization means that participants are placed into one of the treatment groups by chance.
The research study procedures include screening for eligibility and study treatment including evaluations of muscle strength, cardiorespiratory fitness, physical fitness assessments, body composition including DEXA scans, blood tests, and surveys at study entry and follow-up visits.
Participation is expected to last about 4 months for the Exercise Group (PARE) and 9 months for the Waitlist Control Group.
It is expected about 30 people with take part in this research study.
Dana-Farber Cancer Institute is supporting this research study by providing funding through the Population Sciences Team Science Concept program.
- Being tested
- PARE, Waitlist Control Group
- Keywords
- Multiple Myeloma, Autologous Stem Cell Transplant, Aerobic Exercise Program, Resistance Exercise Program
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAREBehavioural
Also called Prehabilitation Aerobic and Resistance Exercise training program
Aerobic and resistance exercise program via Zoom platform.
Waitlist Control GroupBehavioural
Normal Activities.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group (PARE) | Experimental | Participants will be randomly assigned to the Exercise Group (PARE) and will complete study procedures as outlined:
* 8 weeks of 3x weekly sessions of virtually supervised aerobic and resistance exercise performed at home using study-provided stationary bike, resistance equipment, heart-rate monitor, and a wi-fi enabled tablet.
* Clinic visits at week 1, week 10, and 30 days post Autologous Stem Cell Transplantation (ASCT).
* Questionnaires and surveys. Receives: Behavioral: PARE |
| Waitlist Control Group | Active comparator | Participants will be randomly assigned to the Waitlist Control Group and will complete study procedures as outlined:
* 8 weeks of continuing with normal daily activities.
* Option to participate in PARE exercise program after study completion.
* 3 clinic visits with option of 5 visits. The two additional visits are for evaluation and testing for those who choose to participate in exercise program after study completion. Receives: Behavioral: Waitlist Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Muscular Strength
The primary analysis is a mean difference in percent change between the intervention (PARE) and the control (Waitlist) groups in lower leg muscle strength measured through leg press.
Measured: Pre-transplant (Week 9, post-intervention), and post-transplant (Week 14-15, 30 Day Post-ASCT Follow-Up)
Secondary outcomes (3)
Difference in Physical Capacity
Physical capacity includes physical function and cardiorespiratory fitness which are measured through the Short Physical Performance Battery (SPPB) protocol and a maximal oxygen uptake (VO2 max) test, respectively. Differences in physical capacity across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.
Measured: up to 9 months
Difference in Patient Reported Outcomes
Patient reported outcomes, including fatigue and quality of life, are assessed through validated questionnaires. Differences in patient reported outcomes across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.
Measured: up to 9 months
Difference in Cardiometabolic Health Outcomes
Cardiometabolic health outcomes, including biomarkers of metabolic syndrome and body composition will be assessed through blood draws and dual-energy X-ray absorptiometry (DEXA), validated and safe measures. Differences in cardiometabolic health outcomes across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start29 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, PhD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706766
- Sponsor's protocol ID
- 22-403
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Publications
Normann AJ, Mo CC, Wilson RL, Perez M, Cutler C, Uno H, Thompson LV, Skinner TL, Richardson PG, Marinac CR, Dieli-Conwright CM. Prehabilitation Exercise Training to Target Improved Muscle Strength in Pretransplant Patients Diagnosed With Multiple Myeloma: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 19;13:e64905. doi: 10.2196/64905.
PubMed 39701583
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial
- ClinicalTrials.gov ID
- NCT05706766
- Acronym / sponsor ID
- 22-403
- Keywords
- Multiple Myeloma, Autologous Stem Cell Transplant, Aerobic Exercise Program, Resistance Exercise Program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 31 Jan 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 goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training program implemented 8 weeks prior to receiving autologous stem cell transplant (ASCT) for multiple myeloma participants will improve muscular strength, physical capacity, patient reported outcomes, and cardiometabolic health outcomes.
The names of the study interventions involved in this study are:
- Prehabilitative aerobic and resistance exercise (PARE) (virtually supervised 8-week aerobic and resistance exercise program)
- Waitlist control (8-week normal activity behavior)
Detailed description
This is a single-center, prospective, parallel-group, randomized controlled study that will enroll patients diagnosed with multiple myeloma planning to receive autologous stem cell transplant (ASCT).
Participants will be randomized into one of the intervention groups: Exercise Group (PARE) versus Waitlist Control Group. Randomization means that participants are placed into one of the treatment groups by chance.
The research study procedures include screening for eligibility and study treatment including evaluations of muscle strength, cardiorespiratory fitness, physical fitness assessments, body composition including DEXA scans, blood tests, and surveys at study entry and follow-up visits.
Participation is expected to last about 4 months for the Exercise Group (PARE) and 9 months for the Waitlist Control Group.
It is expected about 30 people with take part in this research study.
Dana-Farber Cancer Institute is supporting this research study by providing funding through the Population Sciences Team Science Concept program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group (PARE) | Experimental | Behavioral: PAREParticipants will be randomly assigned to the Exercise Group (PARE) and will complete study procedures as outlined: * 8 weeks of 3x weekly sessions of virtually supervised aerobic and resistance exercise performed at home using study-provided stationary bike, resistance equipment, heart-rate monitor, and a wi-fi enabled tablet. * Clinic visits at week 1, week 10, and 30 days post Autologous Stem Cell Transplantation (ASCT). * Questionnaires and surveys. |
| Waitlist Control Group | Active comparator | Behavioral: Waitlist Control GroupParticipants will be randomly assigned to the Waitlist Control Group and will complete study procedures as outlined: * 8 weeks of continuing with normal daily activities. * Option to participate in PARE exercise program after study completion. * 3 clinic visits with option of 5 visits. The two additional visits are for evaluation and testing for those who choose to participate in exercise program after study completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Over 18 years old.
- All patients will have a diagnosis of multiple myeloma, referral to DFCI transplant team, and assigned to the autologous transplantation waiting list for a first transplant.
- Planning to receive autologous stem cell transplant after 8 weeks with or without concurrent neoadjuvant treatments at Dana-Farber Cancer Institute.
- Medical clearance to perform moderate-vigorous intensity aerobic and resistance exercise intervention and fitness testing by their treating physician or a certified clinical exercise physiologist.
- Speak English.
Key exclusion criteria (11 listed)
- History of unstable angina, abnormal resting ECG and/or unstable angina or a heart attack in the previous month to allow safe completion of the cardiopulmonary exercise test (CPET) or VO2peak test.
- Patients with known spinal instability, spinal cord compression or neurological deficits or contraindications that preclude exercise.
- Those who have had recent (within six weeks) spinal surgery or other intervention surgery for pathological fractures.
- Those deemed unsuitable to partake by the transplant or study team.
- Patients at high-risk of impending pathologic fracture of a weight-bearing bone (including spine, hip/femur and humerus) as determined by physician.
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 |
|---|---|---|
| PAREAlso: Prehabilitation Aerobic and Resistance Exercise training programAerobic and resistance exercise program via Zoom platform. | Behavioural | Exercise Group (PARE) |
| Waitlist Control GroupNormal Activities. | Behavioural | Waitlist Control Group |
Primary outcome
Difference in Muscular Strength
Time frame: Pre-transplant (Week 9, post-intervention), and post-transplant (Week 14-15, 30 Day Post-ASCT Follow-Up)
The primary analysis is a mean difference in percent change between the intervention (PARE) and the control (Waitlist) groups in lower leg muscle strength measured through leg press.
3 secondary outcomes
Difference in Physical Capacity
Time frame: up to 9 months
Difference in Patient Reported Outcomes
Time frame: up to 9 months
Difference in Cardiometabolic Health Outcomes
Time frame: up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 39701583Normann AJ, Mo CC, Wilson RL, Perez M, Cutler C, Uno H, Thompson LV, Skinner TL, Richardson PG, Marinac CR, Dieli-Conwright CM. Prehabilitation Exercise Training to Target Improved Muscle Strength in Pretransplant Patients Diagnosed With Multiple Myeloma: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 19;13:e64905. doi: 10.2196/64905.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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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.
Christina Dieli-Conwright, PhD, MPH principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PARE in people with Multiple Myeloma and Stem Cell Transplant Complications, run by Dana-Farber Cancer Institute at 2 sites 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Dieli-Conwright, PhD, MPH (617-582-8321, christinam_dieli-conwright@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Muscular Strength (time frame: Pre-transplant (Week 9, post-intervention), and post-transplant (Week 14-15, 30 Day Post-ASCT Follow-Up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706766, which also lists 1 linked publication.
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 22 Jan 2026.