NCT03006315

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2024

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

8 years

First QC Date

December 20, 2016

Last Update Submit

November 15, 2024

Conditions

Multiple MyelomaMyeloma

Keywords

multiple myelomagarmin vivofit

Outcome Measures

Primary Outcomes (1)

  • Number of patients continuously wearing the device.

    Feasibility of using mobile wearable health device

    1 year

Study Arms (2)

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 deviceBehavioral: 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 deviceBehavioral: Mobile Health quality of life assessements

Interventions

Garmin Vivofit deviceDEVICE

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.

Cohort A: <65 yearsCohort B: >/= 65 years
Mobile Health quality of life assessementsBEHAVIORAL
Cohort A: <65 yearsCohort B: >/= 65 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed Multiple Myeloma participants with clinical and histological confirmation of diagnosis planning to receive chemotherapy

You may qualify if:

  • 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.

You may not qualify if:

  • Plasma cell leukemia
  • POEMS syndrome
  • Amyloidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Related Links

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Neha Korde, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 30, 2016

Study Start

December 1, 2016

Primary Completion

November 14, 2024

Study Completion

November 14, 2024

Last Updated

November 19, 2024

Record last verified: 2024-11

Locations

US(5)