Multiple Myeloma in RelapseNCT05673083
Impact of a Health Technology Intervention on Patient Activation in Multiple Myeloma
An observational study of Multiple Myeloma in Relapse and Multiple Myeloma, run by All4Cure at 7 sites in United States.
Trial summary
The goal of this pilot study is to evaluate the impact of All4Cure enrollment on patients with multiple myeloma. The main question it aims to answer are: Does All4Cure effect patient activation as assessed by the PAM-13 survey? Participants will be asked to: fill out quarterly PAM-13 surveys through the All4Cure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse, Multiple Myeloma, Multiple Myeloma, Refractory
- How many people
- 200 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Mar 2023to Mar 2026
- Phase
- Observational
- 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
Study population: This study will enroll up to 200 patients with a diagnosis of multiple myeloma who are receiving treatment at Cancer Specialists of North Florida (CSNF, Florida), Northwest Medical Specialties (NWMS, Washington state), or Highlands Oncology Group (HOG, Arkansas).
Who may be able to join
- have a diagnosis of multiple myeloma.
- are aged 18 years and older.
- can read and e-consent to participate in the study.
- can speak English.
- can complete surveys at pre-specified intervals.
- have access to a device that would allow for the completion of surveys (including at home, at work, at the oncologist's office or elsewhere).
- are cared for by a physician who is enrolled in All4Cure.
Who cannot join
- 1. Patients will be excluded who are unable to engage with All4Cure or are already participants in All4Cure.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Misson Cancer + Blood
Des Moines, Iowa, 50314
Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Oncology Consultants
Houston, Texas, 77030
Cancer Specialists of North Florida
Jacksonville, Florida, 32003
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 74146
About this study
The goal of this pilot study is to evaluate the impact of All4Cure enrollment on patients with multiple myeloma. The main question it aims to answer are:
- Does All4Cure effect patient activation as assessed by the PAM-13 survey?
Participants will be asked to:
- fill out quarterly PAM-13 surveys through the All4Cure website to assess patient activation.
- fill out monthly Patient Reported Outcome (PRO) surveys through the All4Cure website.
- fill out a baseline and exit All4Cure surveys through the All4Cure website to assess patient perceptions of All4Cure at the beginning and the end of the study.
Read the detailed description
The goal of this pilot study is to evaluate the impact of All4Cure enrollment on patients with multiple myeloma.
This study uses surveys to assess attitudes and perceptions of patients with myeloma at baseline and following their enrollment into All4Cure. The PAM-13 surveys will be administered at baseline and at 3-month intervals for a total of 5 surveys over 12 months. Patient attitudes and perceptions about the All4Cure platform will be assessed at baseline and at 12 months. Physicians caring for patients enrolled in this study will be surveyed twice -- at baseline and when all their patients have completed the study. Additionally, all patients will receive monthly surveys to assess symptoms associated with myeloma and its treatment using 36 survey items obtained from Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE).
The study has the following objectives:
Primary objective To evaluate the impact of All4Cure enrollment on patients with multiple myeloma. The primary endpoint is the effect of All4Cure on patient activation, as assessed by the PAM-13 survey (change in results from baseline survey to the last completed survey).
Secondary objectives:
To evaluate the feasibility (i.e., ≥50% approach-to-enrollment rate of eligible participants and ≥70% completion of at least two PAM-13 surveys over a 12-month period) and acceptability (i.e., ≤20% withdrawing from the study and ≤20% withdrawing from All4Cure) of participation in All4Cure's digital platform for survivors with multiple myeloma.
To evaluate associations between participant activation levels (as assessed by PAM-13) and symptom burden, as measured by the Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE).
To evaluate patient expectations and perceptions of the utility of All4Cure in their care and their association with PAM-13 results.
To evaluate associations between patient participation in the All4Cure platform (e.g. patient visits to the platform, patient posts on the platform, All4Cure posts on patient dashboards, and provision of MyelomaMap™ reports) and PAM-13 results.
To evaluate physician expectations and perceptions of the utility of All4Cure in their care of patients with multiple myeloma and their association with the PAM-13 results of their patients.
- Conditions
- Multiple Myeloma in Relapse, Multiple Myeloma, Multiple Myeloma, Refractory, Multiple Myeloma With Failed Remission
- Keywords
- Multiple Myeloma, All4Cure, Patient Activation, PAM-13
- Medical subject headings
- Multiple Myeloma, Patient Participation
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation
Patient activation emphasizes patients' willingness and ability to take independent actions to manage their health and care. A widely used definition equates patient activation with understanding one's role in the care process and having the knowledge, skill, and confidence to manage one's health and health care. A growing body of evidence shows that patients who are more activated have better health outcomes and care experiences. This will be assessed through the PAM-13 survey which has a scale of 1-4, with 4 being the highest level of patient activation and associated with the best patient outcomes and 1 being the lowest level of patient activation.
Measured: 24 months
Secondary outcomes (2)
Evaluate associations between Patient Activation and symptom burden
Evaluate associations between participant activation levels (as assessed by PAM-13) and symptom burden, as measured by the Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE).
Measured: 24 months
Evaluate the feasibility and acceptability of participation in All4Cure's digital platform for survivors with multiple myeloma
evaluate the feasibility (i.e., ≥50% approach-to-enrollment rate of eligible participants and ≥70% completion of at least two PAM-13 surveys over a 12-month period) and acceptability (i.e., ≤20% withdrawing from the study and ≤20% withdrawing from All4Cure) of participation in All4Cure's digital platform for survivors with multiple myeloma.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Mar 2023
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All4Cure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673083
- Sponsor's protocol ID
- All4Cure02
- Status last verified
- Aug 2025
- First submitted
- 22 Dec 2022
- Last updated
- 4 Sep 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Health Technology Intervention on Patient Activation in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05673083
- Acronym / sponsor ID
- All4Cure02
- Conditions
- Multiple Myeloma in Relapse, Multiple Myeloma, Multiple Myeloma, Refractory, Multiple Myeloma With Failed Remission
- Keywords
- Multiple Myeloma, All4Cure, Patient Activation, PAM-13
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- All4CureIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 6 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 pilot study is to evaluate the impact of All4Cure enrollment on patients with multiple myeloma. The main question it aims to answer are:
- Does All4Cure effect patient activation as assessed by the PAM-13 survey?
Participants will be asked to:
- fill out quarterly PAM-13 surveys through the All4Cure website to assess patient activation.
- fill out monthly Patient Reported Outcome (PRO) surveys through the All4Cure website.
- fill out a baseline and exit All4Cure surveys through the All4Cure website to assess patient perceptions of All4Cure at the beginning and the end of the study.
Detailed description
The goal of this pilot study is to evaluate the impact of All4Cure enrollment on patients with multiple myeloma.
This study uses surveys to assess attitudes and perceptions of patients with myeloma at baseline and following their enrollment into All4Cure. The PAM-13 surveys will be administered at baseline and at 3-month intervals for a total of 5 surveys over 12 months. Patient attitudes and perceptions about the All4Cure platform will be assessed at baseline and at 12 months. Physicians caring for patients enrolled in this study will be surveyed twice -- at baseline and when all their patients have completed the study. Additionally, all patients will receive monthly surveys to assess symptoms associated with myeloma and its treatment using 36 survey items obtained from Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE).
The study has the following objectives:
Primary objective To evaluate the impact of All4Cure enrollment on patients with multiple myeloma. The primary endpoint is the effect of All4Cure on patient activation, as assessed by the PAM-13 survey (change in results from baseline survey to the last completed survey).
Secondary objectives:
To evaluate the feasibility (i.e., ≥50% approach-to-enrollment rate of eligible participants and ≥70% completion of at least two PAM-13 surveys over a 12-month period) and acceptability (i.e., ≤20% withdrawing from the study and ≤20% withdrawing from All4Cure) of participation in All4Cure's digital platform for survivors with multiple myeloma.
To evaluate associations between participant activation levels (as assessed by PAM-13) and symptom burden, as measured by the Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE).
To evaluate patient expectations and perceptions of the utility of All4Cure in their care and their association with PAM-13 results.
To evaluate associations between patient participation in the All4Cure platform (e.g. patient visits to the platform, patient posts on the platform, All4Cure posts on patient dashboards, and provision of MyelomaMap™ reports) and PAM-13 results.
To evaluate physician expectations and perceptions of the utility of All4Cure in their care of patients with multiple myeloma and their association with the PAM-13 results of their patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll up to 200 patients with a diagnosis of multiple myeloma who are receiving treatment at Cancer Specialists of North Florida (CSNF, Florida), Northwest Medical Specialties (NWMS, Washington state), or Highlands Oncology Group (HOG, Arkansas).
Key inclusion criteria (7 listed)
- have a diagnosis of multiple myeloma.
- are aged 18 years and older.
- can read and e-consent to participate in the study.
- can speak English.
- can complete surveys at pre-specified intervals.
Key exclusion criteria (1 listed)
- 1. Patients will be excluded who are unable to engage with All4Cure or are already participants in All4Cure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Activation
Time frame: 24 months
Patient activation emphasizes patients' willingness and ability to take independent actions to manage their health and care. A widely used definition equates patient activation with understanding one's role in the care process and having the knowledge, skill, and confidence to manage one's health and health care. A growing body of evidence shows that patients who are more activated have better health outcomes and care experiences. This will be assessed through the PAM-13 survey which has a scale of 1-4, with 4 being the highest level of patient activation and associated with the best patient outcomes and 1 being the lowest level of patient activation.
2 secondary outcomes
Evaluate associations between Patient Activation and symptom burden
Time frame: 24 months
Evaluate the feasibility and acceptability of participation in All4Cure's digital platform for survivors with multiple myeloma
Time frame: 24 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 4 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma in Relapse and Multiple Myeloma, run by All4Cure at 7 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 7 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
Patient Activation (time frame: 24 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 4 Sep 2025.