Skip to content
Triangle logo TriangleGet started
← Study library

NCT00558896 · REGISTRY CONDITION SEARCH

CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis

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

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2018-04-18

RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with dexamethasone may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.

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

The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)

→

outcome · POSTED

Progression Free Survival (PFS)

→

outcome · POSTED

Duration of Response

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Symptomatic multiple myeloma * Previously treated disease meeting one of the following criteria: * Have light-chain amyloidosis that has been treated with at least one prior regimen * Symptomatic (relapsed or refractory) multiple myeloma * Patients must have received 1-3 treatment regimens * Induction therapy followed by autologous stem cell transplantation and consolidation considered one regimen * Measurable disease, as defined by 1 of the following: * Serum monoclonal protein ≥ 1.0 g by protein electrophoresis * More than 200 mg of monoclonal protein in the urine on 24-hour electrophoresis * Serum immunoglobulin free light chain (FLC) \> 10 mg/dL and an abnormal FLC ratio * Measurable soft tissue plasmacytoma, not previously irradiated * More than 30% plasma cells in bone marrow * At least 10% plasma cells as measured by bone marrow aspirate, bone marrow biopsy, or labeling index * No monoclonal gammopathy of undetermined significance (not applicable for patients with amyloid) * No smoldering myeloma (not applicable for patients with amyloid) PATIENT CHARACTERISTICS: * ECOG performance status 0, 1, or 2 * ANC ≥ 1,000/μL * Platelet count ≥ 75,000/μL * Creatinine ≤ 2.5 mg/dL * Not pregnant or nursing * Women must refrain from breastfeeding during study participation and for at least 28 days after discontinuation of study drug * Negative pregnancy test * Fertile female patients must use two reliable forms of contraception simultaneously at least 28 days before beginning, during, and at least 28 days after completion of study drug * The two methods of reliable contraception must include one highly effective method (i.e., intrauterine device \[IUD\], hormonal \[birth control pills, injections, or implants\], tubal ligation, or partner's vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, or cervical cap) * Fertile male patients must use a latex condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment * Men must agree to abstain from donating semen or sperm during study participation and for 28 days after discontinuation of study drug * Willing to abstain from donating blood during study participation and for 28 days after discontinuation of study drug * No uncontrolled infection * No other active malignancy * No New York Heart Association class III or IV cardiac disease (all patients) * Serum troponin T \> 0.10 ng/mL (amyloid patients only) * No known positivity for HIV or active hepatitis infection * No active deep vein thrombosis or pulmonary embolism that has not been therapeutically anticoagulated * No condition, including the presence of laboratory abnormalities, that places the patient at unacceptable risk for participating in the study or confounds the ability to interpret data from the study * No known hypersensitivity to thalidomide or lenalidomide including development of erythema nodosum if characterized by a desquamating rash * No peripheral neuropathy \> grade 2 PRIOR CONCURRENT THERAPY: * All previous cancer therapy, including chemotherapy and investigational agents, must have been discontinued ≥ 2 weeks prior to study registration * No radiotherapy ≤ 14 days prior to study registration * No other concurrent anti-myeloma therapy * No concurrent radiotherapy, except for palliation of a single painful bone lesion or fracture * Routine concurrent bisphosphonate therapy allowed for patients with myeloma bone disease * Willing and able to take aspirin or alternate prophylactic anticoagulation
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    intervention Names
    1. Drug: dexamethasone
    2. Drug: pomalidomide
    label
    Relapsed Myeloma (<4 Prior Regimens)
    type
    EXPERIMENTAL
  2. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    intervention Names
    1. Drug: dexamethasone
    2. Drug: pomalidomide
    label
    Lenalidomide Refractory Myeloma
    type
    EXPERIMENTAL
  3. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    intervention Names
    1. Drug: dexamethasone
    2. Drug: pomalidomide
    label
    Bortezomib/Lenalidomide Refractory/Relapsed Myeloma
    type
    EXPERIMENTAL
  4. description
    Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    intervention Names
    1. Drug: dexamethasone
    2. Drug: pomalidomide
    label
    Bortezomib/Lenalidomide Relapsed/Refractory Myeloma
    type
    EXPERIMENTAL
  5. description
    Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    intervention Names
    1. Drug: dexamethasone
    2. Drug: pomalidomide
    label
    Relapsed Myeloma (< 4 Prior Regimens)
    type
    EXPERIMENTAL
  6. description
    Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    intervention Names
    1. Drug: dexamethasone
    2. Drug: pomalidomide
    label
    Relapsed/Refractory Myeloma
    type
    EXPERIMENTAL
  7. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    intervention Names
    1. Drug: dexamethasone
    2. Drug: pomalidomide
    label
    Relapsed Amyloidosis
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Bortezomib/Lenalidomide Refractory/Relapsed Myeloma
    2. Bortezomib/Lenalidomide Relapsed/Refractory Myeloma
    3. Lenalidomide Refractory Myeloma
    4. Relapsed Amyloidosis
    5. Relapsed Myeloma (< 4 Prior Regimens)
    6. Relapsed Myeloma (<4 Prior Regimens)
    7. Relapsed/Refractory Myeloma
    description
    40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.
    name
    dexamethasone
    type
    DRUG
  2. arm Group Labels
    1. Bortezomib/Lenalidomide Refractory/Relapsed Myeloma
    2. Bortezomib/Lenalidomide Relapsed/Refractory Myeloma
    3. Lenalidomide Refractory Myeloma
    4. Relapsed Amyloidosis
    5. Relapsed Myeloma (< 4 Prior Regimens)
    6. Relapsed Myeloma (<4 Prior Regimens)
    7. Relapsed/Refractory Myeloma
    description
    2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
    name
    pomalidomide
    other Names
    1. CC-4047
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
378
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Response that was confirmed on 2 consecutive evaluations * Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours; \<=5% plasma cells in bone marrow. * Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
    measure
    The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)
    time Frame
    Duration of study (up to 3 years)
secondary Outcomes
  1. description
    PFS was defined as the time from registration to progression or death due to any cause. PFS was analyzed using Kaplan Meier method. Progression was defined as any one or 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
    measure
    Progression Free Survival (PFS)
    time Frame
    Duration of study (up to 5 years)
  2. description
    Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. Kaplan Meier method was used to compute this outcome.
    measure
    Duration of Response
    time Frame
    Duration of study (up to 5 years)
Full study description
brief Summary
RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with dexamethasone may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.
detailed Description
OBJECTIVES: * To assess the response rate and duration of remission with low-dose CC-4047 plus dexamethasone in patients with relapsed or refractory multiple myeloma or amyloidosis. * To assess the toxicity of CC-4047 plus dexamethasone in this patient population. * To assess in an expansion cohort the response rate with an increase in CC-4047 dose among patients who fail to respond adequately to the initial starting dose following the first 2 courses of treatment. * To assess the response rate and duration of remission with CC-4047 plus dexamethasone in patients with lenalidomide resistant or refractory multiple myeloma. * To assess the response rate and duration of remission with CC-4047 plus dexamethasone in patients with previously treated light chain amyloidosis. * To assess the response rate and duration of remission with low- and high-dose CC-4047 plus dexamethasone in patients with lenalidomide and bortezomib refractory multiple myeloma. * To assess the response rate and duration of remission with high-dose CC-4047 plus dexamethasone in patients with relapsed or refractory myeloma who received ≤ 3 treatment regimens. OUTLINE: Patients are grouped according to disease status (relapsed/refractory myeloma \[closed to accrual as of 8/5/2008\] vs lenalidomide resistant/refractory myeloma \[closed to accrual as of 4/2/2009\] vs previously treated light chain amyloidosis vs lenalidomide and bortezomib resistant/refractory myeloma {low-dose/day}\[closed to accrual as of 11/20/09\] vs lenalidomide and bortezomib resistant/refractory myeloma (high-dose/day) vs relapsed/refractory myeloma {high-dose/day}). Patients receive oral CC-4047 on days 1-28 and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 4 weeks and then at 6 months.
Source references
references
  1. citation
    Dispenzieri A, Buadi F, Laumann K, LaPlant B, Hayman SR, Kumar SK, Dingli D, Zeldenrust SR, Mikhael JR, Hall R, Rajkumar SV, Reeder C, Fonseca R, Bergsagel PL, Stewart AK, Roy V, Witzig TE, Lust JA, Russell SJ, Gertz MA, Lacy MQ. Activity of pomalidomide in patients with immunoglobulin light-chain amyloidosis. Blood. 2012 Jun 7;119(23):5397-404. doi: 10.1182/blood-2012-02-413161. Epub 2012 Apr 4.
    pmid
    22493299
    type
    DERIVED
  2. citation
    Lacy MQ, Allred JB, Gertz MA, Hayman SR, Short KD, Buadi F, Dispenzieri A, Kumar S, Greipp PR, Lust JA, Russell SJ, Dingli D, Zeldenrust S, Fonseca R, Bergsagel PL, Roy V, Stewart AK, Laumann K, Mandrekar SJ, Reeder C, Rajkumar SV, Mikhael JR. Pomalidomide plus low-dose dexamethasone in myeloma refractory to both bortezomib and lenalidomide: comparison of 2 dosing strategies in dual-refractory disease. Blood. 2011 Sep 15;118(11):2970-5. doi: 10.1182/blood-2011-04-348896. Epub 2011 Jun 20.
    pmid
    21690557
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-96a64f65deb613ad7b06
      requested nct id
      NCT00558896
      primary nct id
      NCT00558896
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      ee6c7c4e06b60c629028091606cc76cc0e80a37fac43fcae2ee2ae6efb2cd99d
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-96a64f65deb613ad7b06
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00558896
      occurrences
      1. context exact
        NCT00558896
        end
        11
        exact text
        NCT00558896
        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/792/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      6755c8e495d216639ef94c0fadf8a21cb9422dabde9e7f4658ac53aa81445f38

    Preserved source evidence · Not medical advice