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Mobile Health Device Study for Myeloma Patients

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ClinicalTrials.gov Identifier: NCT03006315
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date December 20, 2016
First Posted Date December 30, 2016
Last Update Posted Date March 22, 2019
Actual Study Start Date December 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 27, 2016)
Number of patients continuously wearing the device. [ Time Frame: 1 year ]
Feasibility of using mobile wearable health device
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03006315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mobile Health Device Study for Myeloma Patients
Official Title Bio-monitoring of Newly Diagnosed Multiple Myeloma Patients Receiving Induction Chemotherapy Using Mobile Wearable Health Devices
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Newly diagnosed Multiple Myeloma participants with clinical and histological confirmation of diagnosis planning to receive chemotherapy
Condition
  • Multiple Myeloma
  • Myeloma
Intervention
  • Device: Garmin 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.
  • Behavioral: Mobile Health quality of life assessements
Study Groups/Cohorts
  • Cohort A: <65 years
    Cohort A will be comprised of participants <65 years old and will accrue a total of 20 patients.
    Interventions:
    • Device: Garmin Vivofit device
    • Behavioral: Mobile Health quality of life assessements
  • Cohort B: >/= 65 years
    Cohort B will be comprised of participants >/= 65 years and will accrue a total of 20 patients.
    Interventions:
    • Device: Garmin Vivofit device
    • Behavioral: Mobile Health quality of life assessements
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 27, 2016)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Neha Korde, MD 212-639-7664
Contact: Ola Landgren, MD 212-639-5126
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03006315
Other Study ID Numbers 16-1662
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Neha Korde, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date March 2019