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

Celgene

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma

Treatments: Device: MyHOPE™ for Multiple Myeloma; Device: MyHope HCP Portal

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04730505

U1111-1263-2809 (Registry Identifier)

NDS-MM-004

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Patient App + HCP Portal (Cohort 1)

Experimental group

Description:

Cohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal

Treatment:

Device: MyHOPE™ for Multiple Myeloma

Device: MyHope HCP Portal

Patient App Alone (Cohort 2)

Experimental group

Description:

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

Treatment:

Device: MyHOPE™ for Multiple Myeloma