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NCT01668719 · OUTCOME

Progression-free Survival

S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma · Source last updated 2026-04-28

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 6 years post registration

What was measured

From date of registration to date of first documentation of progression or death due to any cause. Per the International Uniform Response Criteria for Multiple Myeloma, progression is defined as \>=1 of Serum M protein increase \>= 25% from lowest response level, with an absolute increase of \>= 0.5g/dL; Urine M protein increase \>= 25% from lowest response level, with an absolute increase of \>= 200 mg/24 hrs; If participant had serum M protein \<1 g/dL, urine M protein \<200 mg/24 hrs, and an involved serum free light chain level \>= 10mg/dL at baseline: \>= 25% increase in the difference between involved and uninvolved serum free light chain level with an absolute increase of \>= 10 mg/dL; Bone marrow plasma cell % increase =25% from baseline with the absolute plasma cell % \>=10%; New bone lesions or soft tissue plasmocytomas, or definite increase in size of existing bone lesions or soft tissue plasmocytomas; Development of hypercalcemia that can be attributed solely to multiple myeloma

Analysis population: Eligible and analyzable participants

Groups in this outcome

Arm I (Bortezomib, Lenalidomide, Dexamethasone)

INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO

Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)

INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE:Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO

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

Analysis denominator · Participants

GroupSource count
Arm I (Bortezomib, Lenalidomide, Dexamethasone)52
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)48

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)33.6Not reported19.6NAnot reached
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)31.5Not reported18.654.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        not reached
        group Id
        OG000
        lower Limit
        19.6
        upper Limit
        NA
        value
        33.6
      2. group Id
        OG001
        lower Limit
        18.6
        upper Limit
        54.0
        value
        31.5
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      48
    units
    Participants
description
From date of registration to date of first documentation of progression or death due to any cause. Per the International Uniform Response Criteria for Multiple Myeloma, progression is defined as \>=1 of Serum M protein increase \>= 25% from lowest response level, with an absolute increase of \>= 0.5g/dL; Urine M protein increase \>= 25% from lowest response level, with an absolute increase of \>= 200 mg/24 hrs; If participant had serum M protein \<1 g/dL, urine M protein \<200 mg/24 hrs, and an involved serum free light chain level \>= 10mg/dL at baseline: \>= 25% increase in the difference between involved and uninvolved serum free light chain level with an absolute increase of \>= 10 mg/dL; Bone marrow plasma cell % increase =25% from baseline with the absolute plasma cell % \>=10%; New bone lesions or soft tissue plasmocytomas, or definite increase in size of existing bone lesions or soft tissue plasmocytomas; Development of hypercalcemia that can be attributed solely to multiple myeloma
dispersion Type
95% Confidence Interval
groups
  1. description
    INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
    id
    OG000
    title
    Arm I (Bortezomib, Lenalidomide, Dexamethasone)
  2. description
    INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE:Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
    id
    OG001
    title
    Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
param Type
MEDIAN
population Description
Eligible and analyzable participants
reporting Status
POSTED
time Frame
Up to 6 years post registration
title
Progression-free Survival
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice