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NCT00574080 · REGISTRY CONDITION SEARCH

UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide

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
TERMINATED
Registry last update
2017-11-20

Add three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose chemotherapy regimen immediately before transplant (DPACE/Melphalan) to try to improve myeloma response and acquire longer survival for participants.

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

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baseline

Baseline characteristics

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outcome · POSTED

Event Free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patients with symptomatic multiple myeloma, sensitive or refractory to at least one prior line of chemotherapy. * Karnofsky performance score \> 60%, unless due to MM. * Patients must be \<75 years of age at the time of registration. * Patient must not have had a prior auto- or allotransplant. * Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study. * Negative serology for HIV. * Baseline biopsies and laboratory studies are to be completed within 35 days of registration, within 60 days for scans and radiological studies; patients must not have a history of severe chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies \> 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) \> 50% of predicted. Patients unable to complete pulmonary function tests because of myeloma-related chest pain, must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as P02 greater than 70. * Patients with recent (\< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias are ineligible. Ejection fraction by ECHO or MUGA must be \> 40% and must be performed within 60 days prior to registration, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated. * No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval or if the malignancy is considered much less life threatening than the myeloma. * Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. * Patients must be able to receive full doses of D PACE, in the opinion of the treating investigator, with the exception that patients with creatinine clearance 30-50 ml/min will receive only 50% of the cisplatin dose. Exclusion Criteria: * Fever or active infection requiring intravenous antibiotic, defined as fever or antibiotics within 72 hours from baseline. * Severe renal dysfunction, defined as a creatinine \> 3mg/dl or a creatinine clearance of \< 30ml/min. * Significant neurotoxicity, defined as grade \> 3 neurotoxicity per NCI Common Toxicity Criteria (See Appendix). * Platelet count \< 100,000/mm\^3, or ANC \< 1,000/μl * POEMS Syndrome. * Clinically significant hepatic dysfunction as noted by direct bilirubin or AST \>3 times the upper normal limit or clinically significant concurrent hepatitis. * New York Hospital Association (NYHA) Class III or Class IV heart failure. * Myocardial infarction within the last 6 months. * Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias. * Poorly-controlled hypertension, diabetes mellitus, or other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol. * Prior adriamycin exposure \>450 mg/m\^2 * Prior exposure to thalidomide which resulted in severe toxicity requiring drug discontinuation.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    DPACE Induction, Melphalan/DPACE Transplant 1, BEAM Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases
    intervention Names
    1. Drug: Interim/Maintenance Dexamethasone
    2. Drug: Induction/Consolidation Dexamethasone
    3. Drug: Induction/Consolidation Cisplatin
    4. Drug: Induction/Consolidation Adriamycin
    5. Drug: InductionConsolidation Cyclophosphamide
    6. Drug: Induction/Consolidation Etoposide
    7. Drug: Induction Pegfilgrastim
    8. Drug: Transplant 1 Dexamethasone
    9. Drug: Transplant 1 Cisplatin
    10. Drug: Transplant 1 Adriamycin
    11. Drug: Transplant 1 Cyclophosphamide
    12. Drug: Transplant 1 Etoposide
    label
    Arm A
    type
    EXPERIMENTAL
  2. description
    DPACE Induction, Melphalan/DPACE + VTD Transplant 1, BEAM + VTD Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases
    intervention Names
    1. Drug: Interim/Maintenance Dexamethasone
    2. Drug: Induction/Consolidation Dexamethasone
    3. Drug: Induction/Consolidation Cisplatin
    4. Drug: Induction/Consolidation Adriamycin
    5. Drug: InductionConsolidation Cyclophosphamide
    6. Drug: Induction/Consolidation Etoposide
    7. Drug: Induction Pegfilgrastim
    8. Drug: Transplant 1 Dexamethasone
    9. Drug: Transplant 1 Cisplatin
    10. Drug: Transplant 1 Adriamycin
    11. Drug: Transplant 1 Cyclophosphamide
    12. Drug: Transplant 1 Etoposide
    label
    Arm B
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A
    2. Arm B
    description
    20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
    name
    Interim/Maintenance Dexamethasone
    other Names
    1. Dex
    2. Dexamethasone acetate
    type
    DRUG
  2. arm Group Labels
    1. Arm A
    2. Arm B
    description
    40 mg Days 1-4
    name
    Induction/Consolidation Dexamethasone
    other Names
    1. Dex
    2. Dexamethasone acetate
    type
    DRUG
  3. arm Group Labels
    1. Arm A
    2. Arm B
    description
    10 mg/m2 by continuous infusion Days 1-4
    name
    Induction/Consolidation Cisplatin
    type
    DRUG
  4. arm Group Labels
    1. Arm A
    2. Arm B
    description
    10 mg/m2 by continuous infusion Days 1-4
    name
    Induction/Consolidation Adriamycin
    type
    DRUG
  5. arm Group Labels
    1. Arm A
    2. Arm B
    description
    400 mg/m2 by continuous infusion Days 1-4
    name
    InductionConsolidation Cyclophosphamide
    type
    DRUG
  6. arm Group Labels
    1. Arm A
    2. Arm B
    description
    40 mg/m2 by continuous infusion Days 1-4
    name
    Induction/Consolidation Etoposide
    type
    DRUG
  7. arm Group Labels
    1. Arm A
    2. Arm B
    description
    6 mg Days 6 and 13
    name
    Induction Pegfilgrastim
    type
    DRUG
  8. arm Group Labels
    1. Arm A
    2. Arm B
    description
    20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
    name
    Transplant 1 Dexamethasone
    type
    DRUG
  9. arm Group Labels
    1. Arm A
    2. Arm B
    description
    20 mg/m2 by continuous infusion Days -3 and -2
    name
    Transplant 1 Cisplatin
    type
    DRUG
  10. arm Group Labels
    1. Arm A
    2. Arm B
    description
    20 mg/m2 by continuous infusion Days -3 and -2
    name
    Transplant 1 Adriamycin
    type
    DRUG
  11. arm Group Labels
    1. Arm A
    2. Arm B
    description
    800 mg/m2 by continuous infusion Days -3 and -2
    name
    Transplant 1 Cyclophosphamide
    type
    DRUG
  12. arm Group Labels
    1. Arm A
    2. Arm B
    description
    80 mg/m2 by continuous infusion Days -3 and -2
    name
    Transplant 1 Etoposide
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
20
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Time from study registration until disease progression or death.
    measure
    Event Free Survival
    time Frame
    Up to 3 years 8 months
Full study description
brief Summary
Add three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose chemotherapy regimen immediately before transplant (DPACE/Melphalan) to try to improve myeloma response and acquire longer survival for participants.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      requested nct id
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      primary nct id
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      source kind
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      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      ff9578337d316add3619d55b2bf1f38bb765396bb3295a6b009808305c9a98f3
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-3d5c1b90b1a49017e8ae
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00574080
      occurrences
      1. context exact
        NCT00574080
        end
        11
        exact text
        NCT00574080
        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/296/protocolSection/identificationModule/nctId
      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      ae5c77ae158e5214e3c923e7976bb678a1202999e09dd6945940e6afc7e794ca

    Preserved source evidence · Not medical advice