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NCT03006315Completed

Mobile Health Device Study for Myeloma Patients

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

Source: ClinicalTrials.gov · Last updated 19 Nov 2024

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
40 (actual)
First submitted
20 Dec 2016
Start date
1 Dec 2016
Primary completion date
14 Nov 2024
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT03006315

What you commit to

  • Study type: Observational
  • Participants enrolled: 40
  • From 1 Dec 2016 to the primary completion date, 14 Nov 2024
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • POEMS syndrome

Other

  • Plasma cell leukemia
  • Amyloidosis

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Basking Ridge
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Commack
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Memorial Sloan Kettering Westchester
Coordinator of this site? Confirm its status
HarrisonUnited StatesUnknown status
Memorial Sloan Kettering Monmouth
Coordinator of this site? Confirm its status
MiddletownUnited StatesUnknown status
Memorial Sloan Kettering Bergen
Coordinator of this site? Confirm its status
MontvaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.