Multiple Myeloma Clinical Trial
Mobile Health Device Study for Myeloma Patients
Summary
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.
Eligibility 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
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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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