Mobile Health Device Study for Myeloma Patients

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Multiple Myeloma; Myeloma

Treatments: Device: Garmin Vivofit device; Behavioral: Mobile Health quality of life assessements

Study type: Observational

Funder types: Other

Identifiers

NCT03006315

16-1662

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

40 participants in 2 patient groups

Cohort A: <65 years

Description:

Cohort A will be comprised of participants \<65 years old and will accrue a total of 20 patients.

Treatment:

Behavioral: Mobile Health quality of life assessements

Device: Garmin Vivofit device

Cohort B: >/= 65 years

Description:

Cohort B will be comprised of participants \>/= 65 years and will accrue a total of 20 patients.

Treatment:

Behavioral: Mobile Health quality of life assessements

Device: Garmin Vivofit device