Skip to content
Triangle logo TriangleGet started
← Study library

NCT00056160 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2017-10-19

Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Time to Tumor Progression (TTP)

→

outcome · POSTED

Overall Survival

→

outcome · POSTED

Myeloma Response

→

outcome · POSTED

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.)

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma. * No more than 3 previous anti-myeloma regimens * No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization. * Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample). Exclusion Criteria: * Prior development of disease progression during high-dose dexamethasone containing therapy. * Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed * Laboratory abnormalities: Platelet count less than 75,000/mm cubed * Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL * Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase \[AST\]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase \[ALT\])greater than 3.0 x upper limit of normal * Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL * Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years. * Known hypersensitivity to thalidomide or dexamethasone. * Development of a desquamating rash while taking thalidomide.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    CC-5013 (lenalidomide) plus oral high-dose dexamethasone
    intervention Names
    1. Drug: CC-5013
    2. Drug: Dexamethasone
    label
    CC-5013/Dex
    type
    EXPERIMENTAL
  2. description
    Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    intervention Names
    1. Drug: Dexamethasone
    label
    Placebo/Dex
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. CC-5013/Dex
    description
    Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle.
    name
    CC-5013
    other Names
    1. lenalidomide
    2. Revlimid
    type
    DRUG
  2. arm Group Labels
    1. CC-5013/Dex
    2. Placebo/Dex
    description
    Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.
    name
    Dexamethasone
    other Names
    1. Decadron
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
353
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Time to Tumor Progression (TTP)
    time Frame
    60 weeks (median Time To Progression of CC-5013/Dex treatment group)
secondary Outcomes
  1. description
    Overall survival was calculated as the time from randomization to death from any cause.
    measure
    Overall Survival
    time Frame
    170 weeks (median overall survival of CC-5013/Dex treatment group)
  2. description
    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.
    measure
    Myeloma Response
    time Frame
    Up to Unblinding (07 Jun 2005)
  3. description
    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.
    measure
    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.)
    time Frame
    30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)
Full study description
brief Summary
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
detailed Description
This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.
Source references
references
  1. citation
    Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.
    pmid
    18032763
    type
    RESULT
  2. citation
    San-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):38-43. doi: 10.3816/CLML.2010.n.120.
    pmid
    21273172
    type
    DERIVED
  3. citation
    Zangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. doi: 10.1200/JCO.2009.23.0169. Epub 2009 Nov 9.
    pmid
    19901114
    type
    DERIVED
  4. citation
    Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. doi: 10.1182/blood-2008-02-141614. Epub 2008 Sep 17.
    pmid
    18799726
    type
    DERIVED
see Also Links
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-d22d4a1c81dc292163df
      requested nct id
      NCT00056160
      primary nct id
      NCT00056160
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      f56bf0ca81eb9f8c5327e2a9f9800adf08670e357b1b384bbce1a0debc4cfd2d
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-d22d4a1c81dc292163df
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00056160
      occurrences
      1. context exact
        NCT00056160
        end
        11
        exact text
        NCT00056160
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/61/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      9da66116c97ebd8409bd11d562b781f4746d5a988ded8c209b55368eae5a765f

    Preserved source evidence · Not medical advice