Skip to content
Triangle logo TriangleGet started
← Multiple Myeloma

NCT00056160 · STUDY IN CONTEXT

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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.

primary · POSTED

Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.

Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.

→

secondary · POSTED

Overall survival was calculated as the time from randomization to death from any cause.

Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.

→

secondary · POSTED

The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.

Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.

→

secondary · POSTED

The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.

Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.

→

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
nct id
NCT00056160
trial label
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
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
    nct id
    NCT00056160
    outcome key
    om-0000
    source section id
    NCT00056160-om-0000
    source outcome index
    0
    endpoint
    Time to Tumor Progression (TTP)
    endpoint definition
    Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
    time origin
    60 weeks (median Time To Progression of CC-5013/Dex treatment group)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
    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
    nct id
    NCT00056160
    outcome key
    om-0001
    source section id
    NCT00056160-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    Overall survival was calculated as the time from randomization to death from any cause.
    time origin
    170 weeks (median overall survival of CC-5013/Dex treatment group)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
    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
    nct id
    NCT00056160
    outcome key
    om-0002
    source section id
    NCT00056160-om-0002
    source outcome index
    2
    endpoint
    Myeloma Response
    endpoint definition
    The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.
    time origin
    Up to Unblinding (07 Jun 2005)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.
    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
    nct id
    NCT00056160
    outcome key
    om-0003
    source section id
    NCT00056160-om-0003
    source outcome index
    3
    endpoint
    Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)
    endpoint definition
    The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.
    time origin
    30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
    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
    nct id
    NCT00056160
    outcome key
    om-0000
    arm key
    OG000
    arm label
    CC-5013/Dex
    regimen
    CC-5013 (lenalidomide) plus oral high-dose dexamethasone
    analyzed count
    177
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00056160-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00056160
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo/Dex
    regimen
    Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    analyzed count
    176
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00056160-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00056160
    outcome key
    om-0001
    arm key
    OG000
    arm label
    CC-5013/Dex
    regimen
    CC-5013 (lenalidomide) plus oral high-dose dexamethasone
    analyzed count
    177
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00056160-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00056160
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo/Dex
    regimen
    Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    analyzed count
    176
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00056160-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00056160
    outcome key
    om-0002
    arm key
    OG000
    arm label
    CC-5013/Dex
    regimen
    CC-5013 (lenalidomide) plus oral high-dose dexamethasone
    analyzed count
    177
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00056160-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00056160
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo/Dex
    regimen
    Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    analyzed count
    176
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00056160-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00056160
    outcome key
    om-0003
    arm key
    OG000
    arm label
    CC-5013/Dex
    regimen
    CC-5013 (lenalidomide) plus oral high-dose dexamethasone
    analyzed count
    177
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00056160-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00056160
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo/Dex
    regimen
    Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    analyzed count
    176
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00056160-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00056160
    harm key
    EG000
    source section id
    NCT00056160-ae
    event group key
    EG000
    event group label
    CC-5013/Dex
    serious affected
    111
    serious at risk
    177
    other affected
    177
    other at risk
    177
    frequency threshold
    5
    collection period
    Up to 254 weeks (median=48 weeks; mean=77 weeks)
    event definition
    Analyses of safety (Serious Adverse Events and Other Adverse Events) were based upon the Safety Population (all subjects who were administered at least one dose of study medication) and include all data available.
    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
    nct id
    NCT00056160
    harm key
    EG001
    source section id
    NCT00056160-ae
    event group key
    EG001
    event group label
    Placebo/Dex
    serious affected
    90
    serious at risk
    175
    other affected
    175
    other at risk
    175
    frequency threshold
    5
    collection period
    Up to 254 weeks (median=48 weeks; mean=77 weeks)
    event definition
    Analyses of safety (Serious Adverse Events and Other Adverse Events) were based upon the Safety Population (all subjects who were administered at least one dose of study medication) and include all data available.
    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