Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01919086 · OUTCOME

Number of Participants Evaluated for Toxicity

Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma · Source last updated 2026-03-02

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
2 years

What was measured

Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0.

Groups in this outcome

Patients With Multiple Myeloma

This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM. Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22 Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW). Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression

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

Analysis denominator · Participants

GroupSource count
Patients With Multiple Myeloma30

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients With Multiple Myeloma30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0.
groups
  1. description
    This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM. Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22 Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW). Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
    id
    OG000
    title
    Patients With Multiple Myeloma
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
2 years
title
Number of Participants Evaluated for Toxicity
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice