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

NCT04730505 | Terminated Phase 1

• 2 other identifiers: NDS-MM-004U1111-1263-2809
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 34

Brief 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.

Conditions

Multiple Myeloma

Keywords

Digital Health; Multiple Myeloma; MYHOPE; Hematology Oncology

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Proportion of respondents scoring 4 or 5 on the Patient Platform Usability Survey or Healthcare Provider Platform Survey

  Up to 18 months

• Quality of life measured by Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) total score

  Up to 6 months

Study Arms (2)

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

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

Device: MyHOPE™ for Multiple Myeloma

Interventions

MyHOPE™ for Multiple Myeloma DEVICE

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.

Patient App + HCP Portal (Cohort 1); Patient App Alone (Cohort 2)

MyHope HCP Portal DEVICE

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.

Patient App + HCP Portal (Cohort 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead
• Amalgam Rx: collaborator

Study Sites (34)

Mitchell Cancer Center, University of South Alabama

Mobile, Alabama, 36604, United States

Location

Mayo Cliinic - Scottsdale

Scottsdale, Arizona, 85259, United States

Location

University of Arizona

Tucson, Arizona, 85724-507, United States

Location

James R Berenson MD Inc

West Hollywood, California, 90069, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Cancer Specialists of North Florida - Jacksonville

Jacksonville, Florida, 32258-5472, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Augusta University - Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

Innovation Clinical Research of the Pacific

Honolulu, Hawaii, 96813, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46845, United States

Location

American Oncology Partner Maryland

Bethesda, Maryland, 20817, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Western Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Newland Medical Associates, PC

Southfield, Michigan, 48075, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39402, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

NY Cancer and Blood Specialists

Port Jefferson Station, New York, 11776, United States

Location

Rochester General Hospital - Lipson Cancer Institute

Rochester, New York, 14621, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Cone Health Cancer Center

Greensboro, North Carolina, 27403, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Tri County Hematology Oncology

Canton, Ohio, 44718, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74146, United States

Location

Jefferson Medical Oncology Associates

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Cancer Care Associates of York

York, Pennsylvania, 17403, United States

Location

West Cancer Center

Germantown, Tennessee, 38138, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Community Cancer Trials of Utah

Ogden, Utah, 84405, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Catherine Ludwig

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: February 4, 2021
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (34)