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NCT01381692 · OUTCOME

Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone

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
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
Assessed during cycle 1 (28 days)

What was measured

Temsirolimus in combination with bortezomib, rituximab, dexamethasone were to be escalated using a standard 3+3 design. The MTD was defined as the highest dose level at which no more than 0 in 3 or 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment.

Groups in this outcome

Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)

Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), 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 B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)

Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), 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.

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 A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)7
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)2

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)NANot reportedNot reportedNot reportedThe maximum tolerated dose (MTD) of temsirolimus was not determined because the study was terminated early due to slow accrual.
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)NANot reportedNot reportedNot reportedThe maximum tolerated dose (MTD) of temsirolimus was not determined because the study was terminated early due to slow accrual.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The maximum tolerated dose (MTD) of temsirolimus was not determined because the study was terminated early due to slow accrual.
        group Id
        OG000
        value
        NA
      2. comment
        The maximum tolerated dose (MTD) of temsirolimus was not determined because the study was terminated early due to slow accrual.
        group Id
        OG001
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Temsirolimus in combination with bortezomib, rituximab, dexamethasone were to be escalated using a standard 3+3 design. The MTD was defined as the highest dose level at which no more than 0 in 3 or 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment.
groups
  1. description
    Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), 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 A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)
  2. description
    Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), 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
    OG001
    title
    Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)
param Type
NUMBER
reporting Status
POSTED
time Frame
Assessed during cycle 1 (28 days)
title
Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice