Mobile Health Device Study for Myeloma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2024-11-14

Brief Summary

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

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Detailed Description

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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.

Conditions

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Multiple Myeloma Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A: <65 years

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

Garmin Vivofit device

Intervention Type 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.

Mobile Health quality of life assessements

Intervention Type BEHAVIORAL

Cohort B: >/= 65 years

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

Garmin Vivofit device

Intervention Type 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.

Mobile Health quality of life assessements

Intervention Type BEHAVIORAL

Interventions

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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.

Intervention Type DEVICE

Mobile Health quality of life assessements

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.