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NCT02331368 · OUTCOME

The Number of Patients That Achieve Complete Response

Phase 2 Multi-center Study of Anti-PD-1 During Lymphopenic State After HDT/ASCT for Multiple Myeloma · Source last updated 2018-07-27

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
180 days post-transplant

What was measured

The primary efficacy endpoint is complete response rate. The complete response rate was estimated by the observed proportion of complete responders at day 180. Complete response (CR) was defined as negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow and negative bone marrow flow cytometry.

Analysis population: 32 patients were enrolled. 3 withdrew consent prior to treatment. Of the 29 treated, 26 were evaluable for response (subjects who received 2-9 doses of MK-3475 were evaluable). Of the 26, 23 completed end-of-treatment response evaluation.

Groups in this outcome

Anti-PD-1 (MK-3475)

Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.

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

Analysis denominator · Participants

GroupSource count
Anti-PD-1 (MK-3475)23

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anti-PD-1 (MK-3475)7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
The primary efficacy endpoint is complete response rate. The complete response rate was estimated by the observed proportion of complete responders at day 180. Complete response (CR) was defined as negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow and negative bone marrow flow cytometry.
groups
  1. description
    Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.
    id
    OG000
    title
    Anti-PD-1 (MK-3475)
param Type
COUNT_OF_PARTICIPANTS
population Description
32 patients were enrolled. 3 withdrew consent prior to treatment. Of the 29 treated, 26 were evaluable for response (subjects who received 2-9 doses of MK-3475 were evaluable). Of the 26, 23 completed end-of-treatment response evaluation.
reporting Status
POSTED
time Frame
180 days post-transplant
title
The Number of Patients That Achieve Complete Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice