Mobile Health Device Study for Myeloma Patients

Study Overview
=================
Brief Summary
-----------------
Enrolled participants health status will be tracked by using a mobile health-monitoring device while undergoing chemotherapy for multiple myeloma.

Detailed Description
-----------------
Newly diagnosed multiple myeloma participants receiving induction chemotherapy will be continuously bio-monitored at baseline (1-7 days prior to treatment initiation) and during induction chemotherapy up to completion of 6 cycles using the Garmin Vivofit wearable device. For those patients continuing with ASCT, patients will be bio-monitored up to 90 days post ASCT. The study will include a total of 40 newly diagnosed multiple myeloma participants in two cohorts with 20 patients in each cohort (Cohort A and B). Cohort A will be comprised of patients <65 years. Cohort B will be comprised of patients >/= 65 years.

Official Title
-----------------
Bio-monitoring of Newly Diagnosed Multiple Myeloma Patients Receiving Induction Chemotherapy Using Mobile Wearable Health Devices

Conditions
-----------------
Multiple Myeloma, Myeloma

Intervention / Treatment
-----------------
* Device: Garmin Vivofit device
* Behavioral: Mobile Health quality of life assessements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Newly diagnosed Multiple Myeloma meeting International Myeloma Working Group (IMWG) criteria (as below) participants with clinical and histological confirmation of diagnosis planning to receive chemotherapy are eligible: Newly diagnosed Multiple Myeloma patients will have evidence of underlying end organ damage and/or myeloma defining event attributed to underlying plasma cell proliferative disorder meeting at least one of the following: Hypercalcemia: serum calcium >0.25 mmol/L (> 1 mg/dL) above upper limit of normal or ≥ 2.75 mmol/L (11 mg/dL) Anemia: hemoglobin value <10 g/dL or > 2 g/dL below lower limit of normal Bone disease: ≥ 1 lytic lesions on skeletal X-ray, CT, or PET-CT. For patients with 1 lytic lesion, bone marrow should demonstrate ≥ 10% clonal plasma cells Clonal bone marrow plasma cell percentage ≥ 60% Involved/un-involved serum free light chain ratio ≥100 and involved free light chain >100 mg/L > 1 focal lesion on magnetic resonance imaging study (lesion must be >5 mm) in size All study participants will be required to receive primary chemotherapy treatment at a Memorial Sloan Kettering facility, including regional outpatient sites. All study participants will be required to have a smart phone or tablet device compatible with the Garmin Vivofit device. Exclusion Criteria Plasma cell leukemia POEMS syndrome Amyloidosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A: <65 years<br>Cohort A will be comprised of participants <65 years old and will accrue a total of 20 patients. | Device: Garmin Vivofit device<br>* Participants will be bio-monitored using the Garmin Vivofit mobile wearable device at baseline (at least 1-7 days prior to treatment initiation) and during induction chemotherapy up to completion of 6 cycles. For those patients continuing with ASCT, patients will be bio-monitored up to 90 days post ASCT.<br>Behavioral: Mobile Health quality of life assessements<br> <br> |
| Cohort B: >/= 65 years<br>Cohort B will be comprised of participants >/= 65 years and will accrue a total of 20 patients. | Device: Garmin Vivofit device<br>* Participants will be bio-monitored using the Garmin Vivofit mobile wearable device at baseline (at least 1-7 days prior to treatment initiation) and during induction chemotherapy up to completion of 6 cycles. For those patients continuing with ASCT, patients will be bio-monitored up to 90 days post ASCT.<br>Behavioral: Mobile Health quality of life assessements<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients continuously wearing the device. | Feasibility of using mobile wearable health device | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple myeloma, garmin vivofit