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NCT01393964 · OUTCOME

Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose.

Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function · Source last updated 2017-08-03

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years

What was measured

Serum samples were evaluated for the presence of ADAs using a validated bridging electrochemiluminescence (ECL) immunoassay. Samples in: Cycle 1, Day 1 0 h (pre-dose), Cycle 2, Day 1(Study Day 29), 0 h (pre-dose; 672 h post-dose), Cycle 3, Day 1, 0 h and in cycle thereafter, at end of study/discontinuation, and at 30 and 60 day follow up visits post treatment. ADA Positive Participant: baseline negative with at least one ADA positive sample at any time after initiation of treatment or baseline positive with at least one ADA positive sample at any time after initiation of treatment with a titer 9-fold greater than the baseline; Persistent Positive: ADA positive at 2 or more sequential timepoints at least 12 weeks apart; Last Sample Positive: Not persistent positive and ADA Positive Sample in the last sampling timepoint; Other Positive: not persistent positive with ADA negative sample in the last sampling; ADA Negative: no ADA positive sample after the initiation of treatment.

Analysis population: All participants with baseline ADA result and at least one on-treatment ADA result.

Groups in this outcome

Elotuzumab + LD in Normal Renal Function (NRF) Participants

LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).

Elotuzumab + LD in Severe Renal Impairment (SRI) Participants

Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl \< 30 ml/min but no dialysis.

Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants

Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.

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

Analysis denominator · Participants

GroupSource count
Elotuzumab + LD in Normal Renal Function (NRF) Participants6
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants4
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants6

Reported measurements

Baseline ADA Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab + LD in Normal Renal Function (NRF) Participants1Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants0Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants0Not reportedNot reportedNot reportedNot reported
On-Study ADA Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab + LD in Normal Renal Function (NRF) Participants2Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants1Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants1Not reportedNot reportedNot reportedNot reported
Positive at Cycle 2 pre-dose
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab + LD in Normal Renal Function (NRF) Participants2Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants0Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants1Not reportedNot reportedNot reportedNot reported
Persistent Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab + LD in Normal Renal Function (NRF) Participants0Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants0Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants0Not reportedNot reportedNot reportedNot reported
Last Sample Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab + LD in Normal Renal Function (NRF) Participants1Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants0Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants1Not reportedNot reportedNot reportedNot reported
Other Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab + LD in Normal Renal Function (NRF) Participants1Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants1Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants0Not reportedNot reportedNot reportedNot reported
On-Study ADA Negative
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab + LD in Normal Renal Function (NRF) Participants4Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants3Not reportedNot reportedNot reportedNot reported
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline ADA Positive
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    On-Study ADA Positive
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Positive at Cycle 2 pre-dose
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Persistent Positive
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Last Sample Positive
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Other Positive
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        5
    title
    On-Study ADA Negative
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Serum samples were evaluated for the presence of ADAs using a validated bridging electrochemiluminescence (ECL) immunoassay. Samples in: Cycle 1, Day 1 0 h (pre-dose), Cycle 2, Day 1(Study Day 29), 0 h (pre-dose; 672 h post-dose), Cycle 3, Day 1, 0 h and in cycle thereafter, at end of study/discontinuation, and at 30 and 60 day follow up visits post treatment. ADA Positive Participant: baseline negative with at least one ADA positive sample at any time after initiation of treatment or baseline positive with at least one ADA positive sample at any time after initiation of treatment with a titer 9-fold greater than the baseline; Persistent Positive: ADA positive at 2 or more sequential timepoints at least 12 weeks apart; Last Sample Positive: Not persistent positive and ADA Positive Sample in the last sampling timepoint; Other Positive: not persistent positive with ADA negative sample in the last sampling; ADA Negative: no ADA positive sample after the initiation of treatment.
groups
  1. description
    LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
    id
    OG000
    title
    Elotuzumab + LD in Normal Renal Function (NRF) Participants
  2. description
    Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl \< 30 ml/min but no dialysis.
    id
    OG001
    title
    Elotuzumab + LD in Severe Renal Impairment (SRI) Participants
  3. description
    Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
    id
    OG002
    title
    Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants
param Type
NUMBER
population Description
All participants with baseline ADA result and at least one on-treatment ADA result.
reporting Status
POSTED
time Frame
From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years
title
Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose.
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice