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NCT01779167 · OUTCOME

Number of Adverse Events Experienced With Alternating Thalidomide and Lenalidomide Plus Rituximab for Subjects With Previously Treated Waldenstrom's Macroglobulinemia

Thalidomide, Lenalidomide, and Rituximab for Previously Treated Waldenstrom Macroglobulinemia · Source last updated 2018-07-11

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
approximately 24 months per patient

What was measured

Capture the number of adverse events experienced when combining thalidomide, lenalidomide, and rituximab in patients with previously treated WM

Analysis population: Data was not collected due to early termination.

Groups in this outcome

All Patients

Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 \& 27) Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 \& 28). Lenalidomide will be initiated at a starting dose of 5 mg. Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Patients0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
Capture the number of adverse events experienced when combining thalidomide, lenalidomide, and rituximab in patients with previously treated WM
groups
  1. description
    Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 \& 27) Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 \& 28). Lenalidomide will be initiated at a starting dose of 5 mg. Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc).
    id
    OG000
    title
    All Patients
population Description
Data was not collected due to early termination.
reporting Status
POSTED
time Frame
approximately 24 months per patient
title
Number of Adverse Events Experienced With Alternating Thalidomide and Lenalidomide Plus Rituximab for Subjects With Previously Treated Waldenstrom's Macroglobulinemia
type
SECONDARY

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

Preserved source evidence · Not medical advice