Clinical trial · Observational
Mobile Health Device Study for Myeloma Patients
Bio-monitoring of Newly Diagnosed Multiple Myeloma Patients Receiving Induction Chemotherapy Using Mobile Wearable Health Devices
NCT03006315CI-TRIAL-00082732completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Enrolled participants health status will be tracked by using a mobile health-monitoring device while undergoing chemotherapy for multiple myeloma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Garmin Vivofit device | Device | — | UNRESOLVED |
| Mobile Health quality of life assessements | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A: <65 years
- description
- Cohort A will be comprised of participants \<65 years old and will accrue a total of 20 patients.
- interventionNames
- Device: Garmin Vivofit device
- Behavioral: Mobile Health quality of life assessements
- label
- Cohort B: >/= 65 years
- description
- Cohort B will be comprised of participants \>/= 65 years and will accrue a total of 20 patients.
- interventionNames
- Device: Garmin Vivofit device
- Behavioral: Mobile Health quality of life assessements
Primary outcomes (1)
- measure
- Number of patients continuously wearing the device.
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.