Multiple MyelomaDigiMyQoLNCT07642362
Digital Support for Multiple Myeloma Quality of Life
A study testing Digital support in people with Multiple Myeloma and Patient Reported Outcome (PRO), run by CareAcross at 1 site in Greece.
Trial summary
The objective of this prospective study is to investigate the quality of life of patients with multiple myeloma and the effectiveness of support provided through a personalized web-based platform. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma, Patient Reported Outcome (PRO), Supportive Care in Cancer
- What is being tested?
- Digital support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteGreece
- Study dates
- 27 Feb 2025to Mar 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients with newly diagnosed or relapsed/refractory multiple myeloma
- Patients that are able to use the digital platform/application
Who cannot join
- Patients that are not able to use the digital platform/application
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Alexandra General Hospital
Athens, 11528
Professor Evangelos Terpos, +302132162846, eterpos@med.uoa.gr
About this study
Official title: Digital Support for Enhancing the Quality of Life of Patients With Multiple Myeloma: An Observational, Randomized, Prospective Study (DigiMyQoL)
The objective of this prospective study is to investigate the quality of life of patients with multiple myeloma and the effectiveness of support provided through a personalized web-based platform.
Specifically, the study will compare Patient-Reported Outcomes (PROs) and the associated improvement in side effects and quality of life achieved through appropriate personalized educational and supportive content.
- Conditions
- Multiple Myeloma, Patient Reported Outcome (PRO), Supportive Care in Cancer, Quality of Life
- Being tested
- Digital support
- Keywords
- multiple myeloma, quality of life, qol, patient reported outcome, pro, digital oncology, supportive care
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital supportBehavioural
Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Experimental | Experimental | Participants in this group utilize the personalized digital platform to record adverse events as Patient-Reported Outcomes (PROs). Additionally, they receive short textual personalized educational and supportive material online.
Their standard clinical treatment and monitoring continue unaffected. Receives: Behavioral: Digital support |
| Arm 2 - Control | No intervention | Participants in this group utilize the personalized digital platform to record adverse events as Patient-Reported Outcomes (PROs). They only receive an acknowledgement of their submission. Their standard clinical treatment and monitoring continue unaffected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes (PROs)
Patient-Reported Outcomes (PROs) consisting of treatment related side-effects that patients themselves report on the online platform. The reported side-effects will be evaluated throughout the entire duration of the study.
17 side-effects will be captured (each measured as either present or absent) throughout the study:
- Ocular toxicity
- Fatigue
- Diarrhea
- Constipation
- Neuropathy
- Dermatological toxicity
- Dyspnoea
- Insomnia
- Nausea
- Vomiting
- Dry mouth
- Nail problems
- Memory problems
- Hypertension
- Lower extremity oedema
- Sexual dysfunction
- Bone pain
Only data from patients who report at least 2 times will be eligible for outcome analysis.
The following calculation and evaluation will be conducted:
For each of the two Arms, the percentage of patients who at the final side-effect data collection reported fewer than 50% of the specific side-effects they had reported at previous side-effect data collection timepoints.
Measured: From enrollment, until study completion, average 1 year.
Secondary outcomes (2)
Progression-Free Survival
Progression-free survival: Laboratory-confirmed disease progression or death, measured from study entry
Measured: At 12 months from each patient's enrollment
Overall Survival
Overall survival: Time to death, measured from study entry
Measured: At 12 months from each patient's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start27 Feb 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CareAcross
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Μedical Association for the Study of Cancer Biology and Treatments (Μ.Α.S.CA.B.T.)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642362
- Sponsor's protocol ID
- 160/27022025
- Acronym
- DigiMyQoL
- Status last verified
- Nov 2025
- First submitted
- 21 Apr 2026
- Last updated
- 11 Jun 2026
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Support for Enhancing the Quality of Life of Patients With Multiple Myeloma: An Observational, Randomized, Prospective Study (DigiMyQoL)
- ClinicalTrials.gov ID
- NCT07642362
- Acronym / sponsor ID
- DigiMyQoL / 160/27022025
- Conditions
- Multiple Myeloma, Patient Reported Outcome (PRO), Supportive Care in Cancer, Quality of Life
- Keywords
- multiple myeloma, quality of life, qol, patient reported outcome, pro, digital oncology, supportive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- CareAcrossIndustry (pharma, biotech, devices)
- Collaborators
- Μedical Association for the Study of Cancer Biology and Treatments (Μ.Α.S.CA.B.T.)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 11 Jun 2026 (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 objective of this prospective study is to investigate the quality of life of patients with multiple myeloma and the effectiveness of support provided through a personalized web-based platform.
Specifically, the study will compare Patient-Reported Outcomes (PROs) and the associated improvement in side effects and quality of life achieved through appropriate personalized educational and supportive content.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Experimental | Experimental | Behavioral: Digital supportParticipants in this group utilize the personalized digital platform to record adverse events as Patient-Reported Outcomes (PROs). Additionally, they receive short textual personalized educational and supportive material online. Their standard clinical treatment and monitoring continue unaffected. |
| Arm 2 - Control | No intervention | –Participants in this group utilize the personalized digital platform to record adverse events as Patient-Reported Outcomes (PROs). They only receive an acknowledgement of their submission. Their standard clinical treatment and monitoring continue unaffected. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with newly diagnosed or relapsed/refractory multiple myeloma
- Patients that are able to use the digital platform/application
Key exclusion criteria (1 listed)
- Patients that are not able to use the digital platform/application
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 |
|---|---|---|
| Digital supportPersonalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform. | Behavioural | Arm 1 - Experimental |
Primary outcome
Patient Reported Outcomes (PROs)
Time frame: From enrollment, until study completion, average 1 year.
Patient-Reported Outcomes (PROs) consisting of treatment related side-effects that patients themselves report on the online platform. The reported side-effects will be evaluated throughout the entire duration of the study. 17 side-effects will be captured (each measured as either present or absent) throughout the study: 1. Ocular toxicity 2. Fatigue 3. Diarrhea 4. Constipation 5. Neuropathy 6. Dermatological toxicity 7. Dyspnoea 8. Insomnia 9. Nausea 10. Vomiting 11. Dry mouth 12. Nail problems 13. Memory problems 14. Hypertension 15. Lower extremity oedema 16. Sexual dysfunction 17. Bone pain Only data from patients who report at least 2 times will be eligible for outcome analysis. The following calculation and evaluation will be conducted: For each of the two Arms, the percentage of patients who at the final side-effect data collection reported fewer than 50% of the specific side-effects they had reported at previous side-effect data collection timepoints.
2 secondary outcomes
Progression-Free Survival
Time frame: At 12 months from each patient's enrollment
Overall Survival
Time frame: At 12 months from each patient's enrollment
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 11 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital support in people with Multiple Myeloma and Patient Reported Outcome (PRO), run by CareAcross at 1 site in Greece.
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 2 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. 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 Greece. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcomes (PROs) (time frame: From enrollment, until study completion, average 1 year.). 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 11 Jun 2026.