Mobile Health Device Study for Myeloma Patients



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:December 2016
End Date:June 2020
Contact:Neha Korde, MD
Phone:212-639-7664

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

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

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.

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
We found this trial at
6
sites
Middletown, New Jersey 07748
Phone: 212-639-7664
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 212-639-5126
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Commack, New York 11725
Phone: 212-639-5126
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Commack, NY
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500 Westchester Avenue
Harrison, New York 10604
Phone: 212-639-5126
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Harrison, NY
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-7664
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Montvale, NJ
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Rockville Centre, New York 11570
Phone: 212-639-5126
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Rockville Centre, NY
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