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NCT01349569 · OUTCOME

Effect on Clonogenic Myeloma Precursors

Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission · Source last updated 2019-01-15

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
Baseline, Cycle 3 Day 14, Cycle 6 Day 14, and 1 year

What was measured

Measures of stem cell population and plasma cell population.

Analysis population: Data was not collected for this outcome measure due to technical difficulties in the assay.

Groups in this outcome

Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide

Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle). Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed. Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.

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

Analysis denominator · Participants

GroupSource count
Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide0

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
Measures of stem cell population and plasma cell population.
groups
  1. description
    Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle). Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed. Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.
    id
    OG000
    title
    Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
population Description
Data was not collected for this outcome measure due to technical difficulties in the assay.
reporting Status
POSTED
time Frame
Baseline, Cycle 3 Day 14, Cycle 6 Day 14, and 1 year
title
Effect on Clonogenic Myeloma Precursors
type
SECONDARY

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

Preserved source evidence · Not medical advice