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NCT01668719 · OUTCOME

Response (Partial Response [PR] or Better) Rate

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 6 years post registration

What was measured

Percentage of participants with PR or better to treatment per the International Uniform Response Criteria for Multiple Myeloma stringent Complete Response- CR criteria + normal serum free light chain (FLC) ratio + absence of clonal cells in bone marrow (BM) by immunohistochemistry or immunofluorescence CR- Negative immunofixation (IFX) on serum \& urine M proteins + \<5% plasma cells in BM + disappearance of soft tissue plasmocytomas (STP) very good PR- PR criteria + serum \& urine M proteins detectable by IFX but not on electrophoresis or \>=90% reduction (RED) in serum M protein \& urine M protein \<100 g/24 hrs PR- \>=50% RED in size of STP, if present at baseline \& \>=50% RED in plasma cells, if \>=30% plasma cells in BM at baseline: \& RED in serum M protein of \>=50% \& in urine M protein of \>= 90% or to 200 mg/24hr OR if serum M protein \<1 g/dL, urine M protein \<200 mg/24 hrs, \& involved serum FLC level \>= 10 mg/dl at baseline: \>= 50% RED in (involved-uninvolved) serum FLC levels

Analysis population: Eligible participants assessable for response at follow up. 1 participant on Arm II was not assessable for RR.

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)47

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)88Not reported7695Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)83Not reported6992Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        76
        upper Limit
        95
        value
        88
      2. group Id
        OG001
        lower Limit
        69
        upper Limit
        92
        value
        83
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      47
    units
    Participants
description
Percentage of participants with PR or better to treatment per the International Uniform Response Criteria for Multiple Myeloma stringent Complete Response- CR criteria + normal serum free light chain (FLC) ratio + absence of clonal cells in bone marrow (BM) by immunohistochemistry or immunofluorescence CR- Negative immunofixation (IFX) on serum \& urine M proteins + \<5% plasma cells in BM + disappearance of soft tissue plasmocytomas (STP) very good PR- PR criteria + serum \& urine M proteins detectable by IFX but not on electrophoresis or \>=90% reduction (RED) in serum M protein \& urine M protein \<100 g/24 hrs PR- \>=50% RED in size of STP, if present at baseline \& \>=50% RED in plasma cells, if \>=30% plasma cells in BM at baseline: \& RED in serum M protein of \>=50% \& in urine M protein of \>= 90% or to 200 mg/24hr OR if serum M protein \<1 g/dL, urine M protein \<200 mg/24 hrs, \& involved serum FLC level \>= 10 mg/dl at baseline: \>= 50% RED in (involved-uninvolved) serum FLC levels
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
NUMBER
population Description
Eligible participants assessable for response at follow up. 1 participant on Arm II was not assessable for RR.
reporting Status
POSTED
time Frame
Up to 6 years post registration
title
Response (Partial Response [PR] or Better) Rate
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice