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← Sarclisa Escena: refractory multiple myeloma after prior therapy

NCT00114101 · STUDY IN CONTEXT

Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · POSTED

Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.

Source null

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post-hoc · POSTED

Patients who develop progression (defined in primary outcome measure), died or develop a new primary malignancy (cancer) will summarized in this outcome.

Source null

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primary · POSTED

Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progression was defined per the International Myeloma Working Group definition as one more of the following: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * 25 % increase in bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas * Development of hypercalcemia

Source null

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secondary · POSTED

Response was defined according to International Myeloma Working Group criteria (2006) * Complete Response: Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Partial Response: \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels * Marginal Response: 25-49% reduction in serum M-component \& urine M-component by 50-89% which still exceeds 200mg/24hour * Progressive Disease: Defined in primary outcome measure * Stable Disease: Not meeting any of the criteria above

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00114101
trial label
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
applicability
unclear
applicability note
Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
4
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0002
    source section id
    NCT00114101-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.
    time origin
    Duration of study (up to 10 years)
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0003
    source section id
    NCT00114101-om-0003
    source outcome index
    3
    endpoint
    Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy
    endpoint definition
    Patients who develop progression (defined in primary outcome measure), died or develop a new primary malignancy (cancer) will summarized in this outcome.
    time origin
    Duration of study (up to 10 years)
    analysis role
    post-hoc
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0000
    source section id
    NCT00114101-om-0000
    source outcome index
    0
    endpoint
    Time to Progression
    endpoint definition
    Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progression was defined per the International Myeloma Working Group definition as one more of the following: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * 25 % increase in bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas * Development of hypercalcemia
    time origin
    Duration of study (up to 10years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0001
    source section id
    NCT00114101-om-0001
    source outcome index
    1
    endpoint
    Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
    endpoint definition
    Response was defined according to International Myeloma Working Group criteria (2006) * Complete Response: Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Partial Response: \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels * Marginal Response: 25-49% reduction in serum M-component \& urine M-component by 50-89% which still exceeds 200mg/24hour * Progressive Disease: Defined in primary outcome measure * Stable Disease: Not meeting any of the criteria above
    time origin
    Day 100
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Lenalidomide Maintenance
    regimen
    Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
    analyzed count
    231
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00114101-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo Maintenance
    regimen
    Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
    analyzed count
    229
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00114101-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Lenalidomide Maintenance
    regimen
    Beginning between day 100-110, patients receive oral lenalidomide once daily.
    analyzed count
    231
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00114101-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo Maintenance
    regimen
    Beginning between day 100-110, patients receive oral placebo once daily. (closed as of 12/17/09)
    analyzed count
    229
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00114101-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Lenalidomide Maintenance
    regimen
    Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
    analyzed count
    231
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00114101-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo Maintenance
    regimen
    Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
    analyzed count
    229
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00114101-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Lenalidomide Maintenance
    regimen
    Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
    analyzed count
    231
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00114101-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo Maintenance
    regimen
    Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
    analyzed count
    229
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00114101-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    harm key
    EG000
    source section id
    NCT00114101-ae
    event group key
    EG000
    event group label
    Lenalidomide Maintenance
    serious affected
    52
    serious at risk
    231
    other affected
    195
    other at risk
    231
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00114101
    harm key
    EG001
    source section id
    NCT00114101-ae
    event group key
    EG001
    event group label
    Placebo Maintenance
    serious affected
    33
    serious at risk
    229
    other affected
    166
    other at risk
    229
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice