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

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ClinicalTrials.gov Identifier: NCT04730505
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : March 26, 2021
Sponsor:
Collaborator:
Amalgam Rx
Information provided by (Responsible Party):
Celgene

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Device: MyHOPE™ for Multiple Myeloma Device: MyHope HCP Portal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : February 4, 2021
Estimated Primary Completion Date : July 27, 2022
Estimated Study Completion Date : July 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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.




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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


Secondary Outcome Measures :
  1. Proportion of respondents scoring 4 or 5 on the Patient Platform Usability Survey or Healthcare Provider Platform Survey [ Time Frame: Up to 18 months ]
    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

  2. Quality of life measured by Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) total score [ Time Frame: Up to 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730505


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@bms.com

Locations
Show Show 24 study locations
Sponsors and Collaborators
Celgene
Amalgam Rx
Investigators
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Study Director: Catherine Ludwig Bristol-Myers Squibb
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04730505    
Other Study ID Numbers: NDS-MM-004
U1111-1263-2809 ( Registry Identifier: WHO )
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Digital Health
Multiple Myeloma
MYHOPE
Hematology Oncology
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases