A Study to Evaluate the My Hematology Oncology Patient Experience (MyHOPE™) For Multiple Myeloma (MM) Digital Care Network in Patients With MM

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Device: MyHOPE™ for Multiple Myeloma
* Device: MyHope HCP Portal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient App + HCP Portal (Cohort 1)<br>Cohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal | Device: MyHOPE™ for Multiple Myeloma<br>* 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.<br>Device: MyHope HCP Portal<br>* 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.<br>|
| Experimental: Patient App Alone (Cohort 2)<br>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 | Device: MyHOPE™ for Multiple Myeloma<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 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 | 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 | 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) | 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 | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Health, Multiple Myeloma, MYHOPE, Hematology Oncology