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

Multiple Myeloma Clinical Trial

— MyHOPE™  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04730505
• Other study ID #: NDS-MM-004
• Secondary ID: U1111-1263-2809
• Status: Terminated
• Phase: Phase 1
• Start date: February 4, 2021
• Est. completion date: June 21, 2021

Study information

• Verified date: July 2021
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. and designed to provide patients with a comprehensive set of tools and resources to support the patient throughout their overall experience with MM.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Newly-diagnosed multiple myeloma transplant-eligible

2. Patients undergoing their first ASCT

3. Newly-diagnosed multiple myeloma transplant-ineligible

4. 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Device:
• MyHOPE™ for Multiple Myeloma
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 Portal
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.

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Augusta University - Georgia Cancer Center	Augusta	Georgia
United States	American Oncology Partner Maryland	Bethesda	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tri County Hematology Oncology	Canton	Ohio
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	West Cancer Center	Germantown	Tennessee
United States	Cone Health Cancer Center	Greensboro	North Carolina
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Innovation Clinical Research of the Pacific	Honolulu	Hawaii
United States	Cancer Specialists of North Florida - Jacksonville	Jacksonville	Florida
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Western Michigan Cancer Center	Kalamazoo	Michigan
United States	Mitchell Cancer Center, University of South Alabama	Mobile	Alabama
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Community Cancer Trials of Utah	Ogden	Utah
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Jefferson Medical Oncology Associates	Philadelphia	Pennsylvania
United States	NY Cancer and Blood Specialists	Port Jefferson Station	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester General Hospital - Lipson Cancer Institute	Rochester	New York
United States	Mayo Cliinic - Scottsdale	Scottsdale	Arizona
United States	Newland Medical Associates, PC	Southfield	Michigan
United States	University of Arizona	Tucson	Arizona
United States	Oklahoma Cancer Specialists and Research Institute	Tulsa	Oklahoma
United States	James R Berenson MD Inc	West Hollywood	California
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	Cancer Care Associates of York	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Celgene	Amalgam Rx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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