Multiple Myeloma Clinical Trial
Mobile Health Device Study for Myeloma Patients
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.
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 â‰¥ 2.75 mmol/L (11 mg/dL)
Anemia: hemoglobin value <10 g/dL or > 2 g/dL below lower limit of normal
Bone disease: â‰¥ 1 lytic lesions on skeletal X-ray, CT, or PET-CT. For patients with 1 lytic lesion, bone marrow should demonstrate â‰¥ 10% clonal plasma cells
Clonal bone marrow plasma cell percentage â‰¥ 60%
Involved/un-involved serum free light chain ratio â‰¥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.
Plasma cell leukemia
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There are 4 Locations for this study
Basking Ridge New Jersey, , United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
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