Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01381692 · OUTCOME

Phase II: Progression-free Survival

Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma · Source last updated 2021-10-04

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
Assessed every 3 months if <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years

What was measured

Progression-free survival is defined as the time from randomization to progression or death, whichever occurred first. Progression is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia. Progression is defined as at least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed by a second measurement at any time, as well as an absolute increase of the M-spike by 0.5g/dL, or progression of clinically significant findings due to disease, (i.e. anemia, thrombocytopenia, leukopenia, bulky adenopathy/organomegaly or symptoms of disease) or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis attributable to WM.

Analysis population: No patients were enrolled in the phase II part of this study.

Groups in this outcome

Arm E (Phase II: Rituximab, Bortezomib, Dexamethasone)

Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only) and bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Arm F (Phase II: Temsirolimus, Rituximab, Bortezomib, Dexamethasone)

Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and rituximab, bortezomib, and dexamethasone as in arm E. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Arm E (Phase II: Rituximab, Bortezomib, Dexamethasone)0
Arm F (Phase II: Temsirolimus, Rituximab, Bortezomib, Dexamethasone)0

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
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Progression-free survival is defined as the time from randomization to progression or death, whichever occurred first. Progression is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia. Progression is defined as at least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed by a second measurement at any time, as well as an absolute increase of the M-spike by 0.5g/dL, or progression of clinically significant findings due to disease, (i.e. anemia, thrombocytopenia, leukopenia, bulky adenopathy/organomegaly or symptoms of disease) or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis attributable to WM.
groups
  1. description
    Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only) and bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm E (Phase II: Rituximab, Bortezomib, Dexamethasone)
  2. description
    Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and rituximab, bortezomib, and dexamethasone as in arm E. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Arm F (Phase II: Temsirolimus, Rituximab, Bortezomib, Dexamethasone)
population Description
No patients were enrolled in the phase II part of this study.
reporting Status
POSTED
time Frame
Assessed every 3 months if <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years
title
Phase II: Progression-free Survival
type
PRIMARY

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

Preserved source evidence · Not medical advice