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Trial record 88 of 530 for:    Neoplasms | Recruiting, Not yet recruiting, Available Studies | "Multiple Myeloma"

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 : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

Condition or disease Intervention/treatment
Multiple Myeloma Myeloma Device: Garmin Vivofit device Behavioral: Mobile Health quality of life assessements

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bio-monitoring of Newly Diagnosed Multiple Myeloma Patients Receiving Induction Chemotherapy Using Mobile Wearable Health Devices
Actual Study Start Date : December 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
Cohort A: <65 years
Cohort A will be comprised of participants <65 years old and will accrue a total of 20 patients.
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
Cohort B: >/= 65 years
Cohort B will be comprised of participants >/= 65 years and will accrue a total of 20 patients.
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



Primary Outcome Measures :
  1. Number of patients continuously wearing the device. [ Time Frame: 1 year ]
    Feasibility of using mobile wearable health device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed Multiple Myeloma participants with clinical and histological confirmation of diagnosis planning to receive chemotherapy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006315


Contacts
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Contact: Neha Korde, MD 212-639-7664
Contact: Ola Landgren, MD 212-639-5126

Locations
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United States, New Jersey
Memoral Sloan Kettering Cancer Center Basking Ridge Recruiting
Basking Ridge, New Jersey, United States
Contact: Neha Korder, MD    212-639-5126      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Neha Korde, MD    212-639-7664      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Neha Korde, MD    212-639-5126      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Neha Korde, MD    212-639-5126      
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States
Contact: Neha Korde, MD    212-639-5126      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Neha Korde, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03006315     History of Changes
Other Study ID Numbers: 16-1662
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
multiple myeloma
garmin vivofit

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases