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NCT02353468 · ADVERSE EVENTS

Adverse events

Bortezomib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant · Source last updated 2015-03-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Patients were assessed for adverse events for approximately 2 years until the study was terminated.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Enzyme Inhibitor, Biological Therapy, Chemotherapy

CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity. In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days. MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Lenalidomide: Given PO Dexamethasone: Given PO or IV

0 / 30 / 3Not reported / Not reported

Group identifiers: EG000: Enzyme Inhibitor, Biological Therapy, Chemotherapy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      event Groups
      1. description
        CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity. In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days. MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Lenalidomide: Given PO Dexamethasone: Given PO or IV
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        3
        serious Num Affected
        0
        serious Num At Risk
        3
        title
        Enzyme Inhibitor, Biological Therapy, Chemotherapy
      frequency Threshold
      0
      time Frame
      Patients were assessed for adverse events for approximately 2 years until the study was terminated.

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice