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NCT04850846 · OUTCOME

(M-)Protein Concentrations Change

Investigation of Metformin for the Prevention of Progression of Precursor Multiple Myeloma · Source last updated 2026-02-09

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

Measure
MEDIAN
Unit
percent change
Interval / dispersion
Full Range
Time frame
Baseline to 6-months

What was measured

Assessed by using the serum-protein electrophoresis

Analysis population: 8 participants in the metformin arm and 6 participants in the control arm did not have analyzable m-protein data.

Groups in this outcome

Metformin

Randomly assigned participants receive a stepped dose escalation until target daily dose of 1500mg Metformin XR is reached (3 x 500mg pills/day). The intervention duration will last an additional 6 months. Metformin Extension: Participants will have the option of unblinding at the end of their 6months treatment and those who were randomly assigned to the metformin experimental arm can continue taking metformin if they opt in. The extended intervention duration will last an additional 6 months. (1500mg Metformin XR or highest tolerated dose ) Metformin XR: Orally by mouth

Placebo

Randomly assigned participants receive a stepped dose escalation until target daily dose of 3 pills/day is reached. The intervention duration will last 6 months. Placebo: Orally by mouth

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

Analysis denominator · Participants

GroupSource count
Metformin22
Placebo24

Reported measurements

Source class 1
Values in percent change · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Metformin-3.2Not reported-33.020.4Not reported
Placebo7.7Not reported-15.429.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -33.0
        upper Limit
        20.4
        value
        -3.2
      2. group Id
        OG001
        lower Limit
        -15.4
        upper Limit
        29.7
        value
        7.7
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      24
    units
    Participants
description
Assessed by using the serum-protein electrophoresis
dispersion Type
Full Range
groups
  1. description
    Randomly assigned participants receive a stepped dose escalation until target daily dose of 1500mg Metformin XR is reached (3 x 500mg pills/day). The intervention duration will last an additional 6 months. Metformin Extension: Participants will have the option of unblinding at the end of their 6months treatment and those who were randomly assigned to the metformin experimental arm can continue taking metformin if they opt in. The extended intervention duration will last an additional 6 months. (1500mg Metformin XR or highest tolerated dose ) Metformin XR: Orally by mouth
    id
    OG000
    title
    Metformin
  2. description
    Randomly assigned participants receive a stepped dose escalation until target daily dose of 3 pills/day is reached. The intervention duration will last 6 months. Placebo: Orally by mouth
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
8 participants in the metformin arm and 6 participants in the control arm did not have analyzable m-protein data.
reporting Status
POSTED
time Frame
Baseline to 6-months
title
(M-)Protein Concentrations Change
type
PRIMARY
unit Of Measure
percent change

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

Preserved source evidence · Not medical advice