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NCT00843310 · OUTCOME

Toxicity, Time to Progression & Progression Free Survival

Combination of Revlimid, Melphalan and Dexamethasone as First Line Treatment for Multiple Myeloma · Source last updated 2017-07-19

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
every 28 days during therapy and every month after therapy for 2 years

What was measured

Toxicity will be scored using CTCAE version 3.0 for toxicity and adverse event reporting. Progressive Disease: requires any one or more of the following: 1. Increase of ≥25% from baseline in Serum M-component and/or (the absolute increase must be ≥0.5 g/dl)b 2. Urine M-component and/or (the absolute increase must be ≥200 mg/24 h 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \>10 mg/dl. 4. Bone marrow plasma cell percentage: the absolute % must be ≥10%c 5. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas 6. Development of hypercalcemia (corrected serum calcium \>11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder

Analysis population: No data are available because data were not collected. Pi left the institution and slow accrual did not allow for sufficient data collection prior to PI leaving institution. No data were analyzed.

Groups in this outcome

ReMeDex

Treatment phase (28 days/cycle x 6 cycles): Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22. Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase): lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles.

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

Analysis denominator · Participants

GroupSource count
ReMeDex0

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
Toxicity will be scored using CTCAE version 3.0 for toxicity and adverse event reporting. Progressive Disease: requires any one or more of the following: 1. Increase of ≥25% from baseline in Serum M-component and/or (the absolute increase must be ≥0.5 g/dl)b 2. Urine M-component and/or (the absolute increase must be ≥200 mg/24 h 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \>10 mg/dl. 4. Bone marrow plasma cell percentage: the absolute % must be ≥10%c 5. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas 6. Development of hypercalcemia (corrected serum calcium \>11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder
groups
  1. description
    Treatment phase (28 days/cycle x 6 cycles): Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22. Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase): lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles.
    id
    OG000
    title
    ReMeDex
population Description
No data are available because data were not collected. Pi left the institution and slow accrual did not allow for sufficient data collection prior to PI leaving institution. No data were analyzed.
reporting Status
POSTED
time Frame
every 28 days during therapy and every month after therapy for 2 years
title
Toxicity, Time to Progression & Progression Free Survival
type
PRIMARY

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

Preserved source evidence · Not medical advice