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

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Myeloma
• Intervention / Treatment: Device: MyHOPE™ for Multiple Myeloma; Device: MyHope HCP Portal

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • Mitchell Cancer Center, University of South Alabama
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Cliinic - Scottsdale
    • Tucson, Arizona, United States, 85724-507
      • University of Arizona
  • California
    • West Hollywood, California, United States, 90069
      • James R Berenson MD Inc
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Jacksonville
    • Jacksonville, Florida, United States, 32258-5472
      • Cancer Specialists of North Florida - Jacksonville
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University
    • Augusta, Georgia, United States, 30912
      • Augusta University - Georgia Cancer Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Innovation Clinical Research of the Pacific
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Fort Wayne Medical Oncology and Hematology
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • American Oncology Partner Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Western Michigan Cancer Center
    • Southfield, Michigan, United States, 48075
      • Newland Medical Associates, PC
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39402
      • Hattiesburg Clinic
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai
    • Port Jefferson Station, New York, United States, 11776
      • Ny Cancer and Blood Specialists
    • Rochester, New York, United States, 14621
      • Rochester General Hospital - Lipson Cancer Institute
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Greensboro, North Carolina, United States, 27403
      • Cone Health Cancer Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Canton, Ohio, United States, 44718
      • Tri County Hematology Oncology
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Medical Oncology Associates
    • York, Pennsylvania, United States, 17403
      • Cancer Care Associates of York
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • West Cancer Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
  • Utah
    • Ogden, Utah, United States, 84405
      • Community Cancer Trials of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient App + HCP Portal (Cohort 1); 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; 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.; Device: 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.
Experimental: Patient App Alone (Cohort 2); 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Celgene
• Collaborators: Amalgam Rx
• Investigators: Study Director: Catherine Ludwig, Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Digital Health; MYHOPE; Hematology Oncology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: NDS-MM-004; U1111-1263-2809 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No