Multiple MyelomaPhase 1MyHOPE™NCT04730505
A Study to Evaluate the My Hematology Oncology Patient Experience (MyHOPE™) For Multiple Myeloma (MM) Digital Care Network in Patients With MM
A Phase 1 study testing MyHOPE™ for Multiple Myeloma and MyHope HCP Portal in people with Multiple Myeloma, run by Celgene at 34 sites in United States.
Trial summary
NDS-MM-004 is a multi-center, randomized, pilot trial to evaluate the MyHOPE for multiple myeloma (MM) Platform in patients with MM. The MyHOPE for MM Platform is a validated investigational device manufactured by Amalgam Rx, Inc. 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?
- MyHOPE™ for Multiple Myeloma and MyHope HCP Portal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 34 sitesUnited States
- Study dates
- 4 Feb 2021to 21 Jun 2021
- Phase
- Phase 1
- 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
- Patient is ≥ 18 years old with a diagnosis of Multiple Myeloma
- Patient must reside in the USA.
- Patients within each of the following subgroups, at one of the following timepoints, will be eligible for entry:
- Newly-diagnosed multiple myeloma transplant-eligible
- Patients undergoing their first ASCT
- Newly-diagnosed multiple myeloma transplant-ineligible
- Relapsed and/or refractory.
Who cannot join
- Patient has a condition(s) that, in the opinion of the Investigator, would make participation infeasible such as inability to provide informed consent, illiteracy, or inability to speak, read, and write in English.
- Patient is on hospice.
- Patient is receiving or has received an investigational agent < 28 days prior to randomization or during this pilot study.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Augusta University - Georgia Cancer Center
Augusta, Georgia, 30912
American Oncology Partner Maryland
Bethesda, Maryland, 20817
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Tri County Hematology Oncology
Canton, Ohio, 44718
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27705
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46845
West Cancer Center
Germantown, Tennessee, 38138
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Hattiesburg Clinic
Hattiesburg, Mississippi, 39402
Innovation Clinical Research of the Pacific
Honolulu, Hawaii, 96813
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Cancer Specialists of North Florida - Jacksonville
Jacksonville, Florida, 32258-5472
Western Michigan Cancer Center
Kalamazoo, Michigan, 49007
Mitchell Cancer Center, University of South Alabama
Mobile, Alabama, 36604
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Community Cancer Trials of Utah
Ogden, Utah, 84405
Jefferson Medical Oncology Associates
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
NY Cancer and Blood Specialists
Port Jefferson Station, New York, 11776
Mayo Clinic
Rochester, Minnesota, 55905
Rochester General Hospital - Lipson Cancer Institute
Rochester, New York, 14621
Mayo Cliinic - Scottsdale
Scottsdale, Arizona, 85259
Newland Medical Associates, PC
Southfield, Michigan, 48075
University of Arizona
Tucson, Arizona, 85724-507
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 74146
James R Berenson MD Inc
West Hollywood, California, 90069
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Cancer Care Associates of York
York, Pennsylvania, 17403
About this study
Official title: A Multi-center, Randomized, Pilot Trial to Evaluate the My Hematology Oncology Patient Experience (MYHOPE™) for Multiple Myeloma (MM) Digital Care Network in Patients With MM
NDS-MM-004 is a multi-center, randomized, pilot trial to evaluate the MyHOPE for multiple myeloma (MM) Platform in patients with MM. The MyHOPE for MM Platform is a validated investigational device manufactured by Amalgam Rx, Inc. and designed to provide patients with a comprehensive set of tools and resources to support the patient throughout their overall experience with MM.
- Conditions
- Multiple Myeloma
- Being tested
- MyHOPE™ for Multiple Myeloma, MyHope HCP Portal
- Keywords
- Digital Health, Multiple Myeloma, MYHOPE, Hematology Oncology
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyHOPE™ for Multiple MyelomaDevice
The MyHOPE for MM Platform is designed to provide patients with tools and resources to support them in their overall experience with MM. Patients can share their data through a PDF or by showing their device to their care team at clinic visits.
MyHope HCP PortalDevice
Is designed to provide HCPs with the ability to view patient data and symptom notifications (Cohort 1 only) to provide support between clinic visits and to facilitate dialogue during clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Patient App + HCP Portal (Cohort 1) | Experimental | Cohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal Receives: Device: MyHOPE™ for Multiple Myeloma; Device: MyHope HCP Portal |
| Patient App Alone (Cohort 2) | Experimental | Cohort 2 is to assess how patients will use the Patient App where there is no connectivity to the Healthcare professional (HCP) Portal and thus no real-time data sharing with the HCP Portal Receives: Device: MyHOPE™ for Multiple Myeloma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly eligibility and recruitment rates per month of patients with multiple myeloma
is defined as the number of patients with MM that satisfied entry criteria per study site/month)
Measured: Up to 12 months
User average weekly log-in rates over the duration of follow-up from patients with MM and HCPs
is defined as the number of times a user attempts to log in/week
Measured: Up to 6 months
Duration of follow-up
is defined as the mean, median, and range of time from each user's first login to his or her last login to the Patient App or to the HCP Portal
Measured: Up to 6 months
Patient-reported outcome completion rates
Is defined as the number of data points that are completed divided by the number of data points that could have been completed at each specified timepoint, relative to the enrollment date of each participant
Measured: Up to 6 months
Frequency of user access by feature and by month, relative to the enrollment date of each participant
Is defined as how often patients access various features of the app, per month relative to the enrollment date of each participant
Measured: Up to 6 months
Percentage of patients for whom the HCPs complete the 6-month assessments
is defined as number of patients for whom HCPs provided 6-month assessments [eg, disease response assessments] divided by the number of patients for whom HCPs provided baseline data)
Measured: up to 18 months
Patient empowerment and self-efficacy measured by CASE-Cancer
The instrument consists of 3 subscales: understanding and participating in care, maintaining a positive attitude, and seeking and obtaining information. All items are scored on a range of 1 to 4 from strongly disagree to strongly agree, with higher score indicating better empowerment
Measured: Up to 6 months
Secondary outcomes (2)
Proportion of respondents scoring 4 or 5 on the Patient Platform Usability Survey or Healthcare Provider Platform Survey
is defined as the number of respondents giving a score of 4 or 5 to each of the questions in the Patient Platform Usability Survey divided by overall number of respondents for that question or number of respondents giving a score of 4 or 5 to each of the questions in the Healthcare Provider Platform Usability Survey divided by overall number of respondents for that question, respectively
Measured: Up to 18 months
Quality of life measured by Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) total score
This scale addresses symptoms and functional limitations that are important to patients with MM. The items are scored on a 0 ("Not at all") to 4 ("Very much") response scale.
Measured: 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 posted29 Jan 2021
- Study start4 Feb 2021
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Why it stopped: Study faced multiple challenges and its launch was heavily impacted by COVID, which in turn has significantly impacted the deployment and adoption goals for a digital technology pilot. These factors led to the difficult decision to close the study.
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 CelgeneThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amalgam Rx
- Responsible party
- Sponsor
- Investigators
- Catherine Ludwig, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730505
- Sponsor's protocol ID
- NDS-MM-004
- Other IDs
- U1111-1263-2809
- Acronym
- MyHOPE™
- Status last verified
- Jul 2021
- First submitted
- 26 Jan 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Pilot Trial to Evaluate the My Hematology Oncology Patient Experience (MYHOPE™) for Multiple Myeloma (MM) Digital Care Network in Patients With MM
- ClinicalTrials.gov ID
- NCT04730505
- Acronym / sponsor ID
- MyHOPE™ / NDS-MM-004
- Conditions
- Multiple Myeloma
- Keywords
- Digital Health, Multiple Myeloma, MYHOPE, Hematology Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study faced multiple challenges and its launch was heavily impacted by COVID, which in turn has significantly impacted the deployment and adoption goals for a digital technology pilot. These factors led to the difficult decision to close the study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Collaborators
- Amalgam Rx
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 29 Jan 2021 (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.
NDS-MM-004 is a multi-center, randomized, pilot trial to evaluate the MyHOPE for multiple myeloma (MM) Platform in patients with MM. The MyHOPE for MM Platform is a validated investigational device manufactured by Amalgam Rx, Inc. and designed to provide patients with a comprehensive set of tools and resources to support the patient throughout their overall experience with MM.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient App + HCP Portal (Cohort 1) | Experimental | Device: MyHOPE™ for Multiple Myeloma, Device: MyHope HCP PortalCohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal |
| Patient App Alone (Cohort 2) | Experimental | Device: MyHOPE™ for Multiple MyelomaCohort 2 is to assess how patients will use the Patient App where there is no connectivity to the Healthcare professional (HCP) Portal and thus no real-time data sharing with the HCP Portal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is ≥ 18 years old with a diagnosis of Multiple Myeloma
- Patient must reside in the USA.
- Patients within each of the following subgroups, at one of the following timepoints, will be eligible for entry:
Key exclusion criteria (3 listed)
- Patient has a condition(s) that, in the opinion of the Investigator, would make participation infeasible such as inability to provide informed consent, illiteracy, or inability to speak, read, and write in English.
- Patient is on hospice.
- Patient is receiving or has received an investigational agent < 28 days prior to randomization or during this pilot study.
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 |
|---|---|---|
| MyHOPE™ for Multiple MyelomaThe MyHOPE for MM Platform is designed to provide patients with tools and resources to support them in their overall experience with MM. Patients can share their data through a PDF or by showing their device to their care team at clinic visits. | Device | Patient App + HCP Portal (Cohort 1), Patient App Alone (Cohort 2) |
| MyHope HCP PortalIs designed to provide HCPs with the ability to view patient data and symptom notifications (Cohort 1 only) to provide support between clinic visits and to facilitate dialogue during clinic visits. | Device | Patient App + HCP Portal (Cohort 1) |
Primary outcome
Monthly eligibility and recruitment rates per month of patients with multiple myeloma
Time frame: Up to 12 months
is defined as the number of patients with MM that satisfied entry criteria per study site/month)
User average weekly log-in rates over the duration of follow-up from patients with MM and HCPs
Time frame: Up to 6 months
is defined as the number of times a user attempts to log in/week
Duration of follow-up
Time frame: Up to 6 months
is defined as the mean, median, and range of time from each user's first login to his or her last login to the Patient App or to the HCP Portal
Patient-reported outcome completion rates
Time frame: Up to 6 months
Is defined as the number of data points that are completed divided by the number of data points that could have been completed at each specified timepoint, relative to the enrollment date of each participant
Frequency of user access by feature and by month, relative to the enrollment date of each participant
Time frame: Up to 6 months
Is defined as how often patients access various features of the app, per month relative to the enrollment date of each participant
Percentage of patients for whom the HCPs complete the 6-month assessments
Time frame: up to 18 months
is defined as number of patients for whom HCPs provided 6-month assessments [eg, disease response assessments] divided by the number of patients for whom HCPs provided baseline data)
Patient empowerment and self-efficacy measured by CASE-Cancer
Time frame: Up to 6 months
The instrument consists of 3 subscales: understanding and participating in care, maintaining a positive attitude, and seeking and obtaining information. All items are scored on a range of 1 to 4 from strongly disagree to strongly agree, with higher score indicating better empowerment
2 secondary outcomes
Proportion of respondents scoring 4 or 5 on the Patient Platform Usability Survey or Healthcare Provider Platform Survey
Time frame: Up to 18 months
Quality of life measured by Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) total score
Time frame: Up to 6 months
Results and safety
The study was stopped early (reason given: Study faced multiple challenges and its launch was heavily impacted by COVID, which in turn has significantly impacted the deployment and adoption goals for a digital technology pilot. These factors led to the difficult decision to close the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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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.
Catherine Ludwig study director
Bristol-Myers Squibb
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MyHOPE™ for Multiple Myeloma and MyHope HCP Portal in people with Multiple Myeloma, run by Celgene at 34 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 3 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: stopped early, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study faced multiple challenges and its launch was heavily impacted by COVID, which in turn has significantly impacted the deployment and adoption goals for a digital technology pilot. These factors led to the difficult decision to close the study.). Results are not available in the source record.
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?
Monthly eligibility and recruitment rates per month of patients with multiple myeloma (time frame: Up to 12 months). The study lists 7 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 9 Aug 2021.