Clinical trial NCT04730505: A Study to Evaluate the My Hematology Oncology Patient Experience (MyHOPE™) For Multiple Myeloma (MM) Digital Care Network in Patients With MM
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Digital Health
Multiple Myeloma
MYHOPE
Hematology Oncology
Lead sponsor: Celgene
Sponsor class: INDUSTRY
Collaborators: name: Amalgam Rx
First posted: 2021-01-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Monthly eligibility and recruitment rates per month of patients with multiple myeloma
timeFrame: Up to 12 months
measure: User average weekly log-in rates over the duration of follow-up from patients with MM and HCPs
timeFrame: Up to 6 months
measure: Duration of follow-up
timeFrame: Up to 6 months
measure: Patient-reported outcome completion rates
timeFrame: Up to 6 months
measure: Frequency of user access by feature and by month, relative to the enrollment date of each participant
timeFrame: Up to 6 months
measure: Percentage of patients for whom the HCPs complete the 6-month assessments
timeFrame: up to 18 months
measure: Patient empowerment and self-efficacy measured by CASE-Cancer
timeFrame: Up to 6 months
Secondary outcomes:
measure: Proportion of respondents scoring 4 or 5 on the Patient Platform Usability Survey or Healthcare Provider Platform Survey
timeFrame: Up to 18 months
measure: Quality of life measured by Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) total score
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mitchell Cancer Center, University of South Alabama
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Cliinic - Scottsdale
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: West Hollywood
country: United States
facility: James R Berenson MD Inc
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida - Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Augusta
country: United States
facility: Augusta University - Georgia Cancer Center
state: Georgia
city: Honolulu
country: United States
facility: Innovation Clinical Research of the Pacific
state: Hawaii
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Bethesda
country: United States
facility: American Oncology Partner Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Kalamazoo
country: United States
facility: Western Michigan Cancer Center
state: Michigan
city: Southfield
country: United States
facility: Newland Medical Associates, PC
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Port Jefferson Station
country: United States
facility: NY Cancer and Blood Specialists
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital - Lipson Cancer Institute
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Canton
country: United States
facility: Tri County Hematology Oncology
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Jefferson Medical Oncology Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: York
country: United States
facility: Cancer Care Associates of York
state: Pennsylvania
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Ogden
country: United States
facility: Community Cancer Trials of Utah
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Catherine Ludwig
role: STUDY_DIRECTOR
References: