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NCT02516423 · OUTCOME

Symptomatic Myeloma Progression Free-survival (PFS) Rate

Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone · Source last updated 2026-06-30

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
18 months

What was measured

Symptomatic myeloma PFS is defined as time from randomization to the first instance of criteria for multiple myeloma (MM). MM is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following: * Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcaemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11 mg/dL); Renal insufficiency: creatinine clearance \<40 mL per min or serum creatinine \>177 μmol/L (\>2 mg/dL); Anaemia: haemoglobin value of \>20 g/L below the lower limit of normal, or a haemoglobin value \<100 g/L; Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT * Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥60%; Involved:uninvolved serum free light chain ratio ≥100 ; \>1 focal lesions on MRI studies

Analysis population: All eligible patients who began protocol treatment

Groups in this outcome

Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid

Patients receive 4 mg ixazomib by mouth on days 1, 8 and 15. Patients also receive 15 mg lenalidomide by mouth on days 1-21, 12 mg dexamethasone by mouth on days 1, 8, 15, and 22 and zoledronic acid (dose based on creatinine clearance on day 1) IV infusion on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.

Zoledronic Acid

Patients receive zoledronic acid (dose based on creatinine clearance on day 1) IV on day 1. Patients receive treatment every 28 days for a maximum of 6 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
Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid5
Zoledronic Acid6

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid100Not reportedNANAConfidence interval could not be calculated due to a low number of events.
Zoledronic Acid41.7Not reported14.7100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Confidence interval could not be calculated due to a low number of events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        100
      2. group Id
        OG001
        lower Limit
        14.7
        upper Limit
        100
        value
        41.7
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Symptomatic myeloma PFS is defined as time from randomization to the first instance of criteria for multiple myeloma (MM). MM is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following: * Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcaemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11 mg/dL); Renal insufficiency: creatinine clearance \<40 mL per min or serum creatinine \>177 μmol/L (\>2 mg/dL); Anaemia: haemoglobin value of \>20 g/L below the lower limit of normal, or a haemoglobin value \<100 g/L; Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT * Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥60%; Involved:uninvolved serum free light chain ratio ≥100 ; \>1 focal lesions on MRI studies
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 4 mg ixazomib by mouth on days 1, 8 and 15. Patients also receive 15 mg lenalidomide by mouth on days 1-21, 12 mg dexamethasone by mouth on days 1, 8, 15, and 22 and zoledronic acid (dose based on creatinine clearance on day 1) IV infusion on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
    id
    OG000
    title
    Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid
  2. description
    Patients receive zoledronic acid (dose based on creatinine clearance on day 1) IV on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
    id
    OG001
    title
    Zoledronic Acid
param Type
NUMBER
population Description
All eligible patients who began protocol treatment
reporting Status
POSTED
time Frame
18 months
title
Symptomatic Myeloma Progression Free-survival (PFS) Rate
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice