Mobile Health Device Study for Myeloma Patients

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03006315

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Myeloma	Device: Garmin Vivofit device Behavioral: Mobile Health quality of life assessements

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.

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cohort A: <65 years Cohort A will be comprised of participants <65 years old and will accrue a total of 20 patients.	Device: Garmin Vivofit device 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. Behavioral: Mobile Health quality of life assessements
Cohort B: >/= 65 years Cohort B will be comprised of participants >/= 65 years and will accrue a total of 20 patients.	Device: Garmin Vivofit device 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. Behavioral: Mobile Health quality of life assessements

Arm

Intervention/Treatment

Cohort A: <65 years

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

Device: Garmin Vivofit device

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.

Behavioral: Mobile Health quality of life assessements

Cohort B: >/= 65 years

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

Device: Garmin Vivofit device

Behavioral: Mobile Health quality of life assessements

Outcome Measures

Primary Outcome Measures

Number of patients continuously wearing the device. [1 year]
Feasibility of using mobile wearable health device

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States
2	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604