Multiple Myeloma Clinical Trial

Mobile Health Device Study for Myeloma Patients

Summary

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

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Full 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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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 gdL 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

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

40

Study ID:

NCT03006315

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 4 Locations for this study

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Memoral Sloan Kettering Basking Ridge
Basking Ridge New Jersey, , United States
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

40

Study ID:

NCT03006315

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

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