Multiple Myeloma, Myeloma
Conditions
Keywords
multiple myeloma, garmin vivofit
Brief summary
Enrolled participants health status will be tracked by using a mobile health-monitoring device while undergoing chemotherapy for multiple myeloma.
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.
Interventions
DEVICEGarmin 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.
BEHAVIORALMobile Health quality of life assessements
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients continuously wearing the device. | 1 year | Feasibility of using mobile wearable health device |
Countries
United States
Outcome results
None listed