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Trial record 99 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

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

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ClinicalTrials.gov Identifier: NCT00574080
Recruitment Status : Terminated (low accrual)
First Posted : December 14, 2007
Results First Posted : June 30, 2011
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE December 12, 2007
First Posted Date  ICMJE December 14, 2007
Results First Submitted Date  ICMJE May 4, 2011
Results First Posted Date  ICMJE June 30, 2011
Last Update Posted Date November 20, 2017
Study Start Date  ICMJE July 2006
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
Event Free Survival [ Time Frame: Up to 3 years 8 months ]
Time from study registration until disease progression or death.
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
To find out if adding, bortezomib, thal, and dex to the high dose chemotherapy regimen immediately before transplant will result in better myeloma response and longer survival of myeloma subjects compared to treatment with high-dose chemotherapy. [ Time Frame: 24 months ]
Change History Complete list of historical versions of study NCT00574080 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
To find out what the side effects will be with both transplant regimens [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide
Official Title  ICMJE UARK 2006-15: A Phase III Randomized Study of Tandem Transplants With or Without Bortezomib (Velcade) and Thalidomide (Thalomid) to Evaluate Its Effect on Response Rate and Durability of Response in Multiple Myeloma Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: Interim/Maintenance Dexamethasone
    20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
    Other Names:
    • Dex
    • Dexamethasone acetate
  • Drug: Induction/Consolidation Dexamethasone
    40 mg Days 1-4
    Other Names:
    • Dex
    • Dexamethasone acetate
  • Drug: Induction/Consolidation Cisplatin
    10 mg/m2 by continuous infusion Days 1-4
  • Drug: Induction/Consolidation Adriamycin
    10 mg/m2 by continuous infusion Days 1-4
  • Drug: InductionConsolidation Cyclophosphamide
    400 mg/m2 by continuous infusion Days 1-4
  • Drug: Induction/Consolidation Etoposide
    40 mg/m2 by continuous infusion Days 1-4
  • Drug: Induction Pegfilgrastim
    6 mg Days 6 and 13
  • Drug: Transplant 1 Dexamethasone
    20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
  • Drug: Transplant 1 Cisplatin
    20 mg/m2 by continuous infusion Days -3 and -2
  • Drug: Transplant 1 Adriamycin
    20 mg/m2 by continuous infusion Days -3 and -2
  • Drug: Transplant 1 Cyclophosphamide
    800 mg/m2 by continuous infusion Days -3 and -2
  • Drug: Transplant 1 Etoposide
    80 mg/m2 by continuous infusion Days -3 and -2
  • Drug: Transplant 1 Melphalan
    50 mg/m2 Days -2 and -1
  • Drug: Transplant 1 and 2 Pegfilgrastim
    6 mg Day +6
  • Procedure: Autologous Peripheral Blood Stem Cell Transplant (ASCT)
    Day 0
  • Drug: Transplant 2 Carmustine
    300 mg/m2 Day -5
  • Drug: Transplant 2 Etoposide
    200 mg/m2 Days -5, -4, -3, -2
  • Drug: Transplant 2 Cytarabine
    400 mg/m2 Days -5, -4, -3, -2
    Other Name: Ara-C
  • Drug: Transplant 2 Melphalan
    140 mg/m2 Day -1
  • Drug: Transplant 2 Dexamethasone
    20 mg Days -5, -4, -3, -2, +4, +5, +6, +7
  • Drug: Transplant 1 and 2 Bortezomib
    1 mg/m2 Days -4, -1, +3, +7
    Other Name: Velcade
  • Drug: Transplant 1 and 2 Thalidomide
    200 mg Days -4 to +5
Study Arms  ICMJE
  • Experimental: Arm A
    DPACE Induction, Melphalan/DPACE Transplant 1, BEAM Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases
    Interventions:
    • Drug: Interim/Maintenance Dexamethasone
    • Drug: Induction/Consolidation Dexamethasone
    • Drug: Induction/Consolidation Cisplatin
    • Drug: Induction/Consolidation Adriamycin
    • Drug: InductionConsolidation Cyclophosphamide
    • Drug: Induction/Consolidation Etoposide
    • Drug: Induction Pegfilgrastim
    • Drug: Transplant 1 Dexamethasone
    • Drug: Transplant 1 Cisplatin
    • Drug: Transplant 1 Adriamycin
    • Drug: Transplant 1 Cyclophosphamide
    • Drug: Transplant 1 Etoposide
    • Drug: Transplant 1 Melphalan
    • Drug: Transplant 1 and 2 Pegfilgrastim
    • Procedure: Autologous Peripheral Blood Stem Cell Transplant (ASCT)
    • Drug: Transplant 2 Carmustine
    • Drug: Transplant 2 Etoposide
    • Drug: Transplant 2 Cytarabine
    • Drug: Transplant 2 Melphalan
    • Drug: Transplant 2 Dexamethasone
  • Experimental: Arm B
    DPACE Induction, Melphalan/DPACE + VTD Transplant 1, BEAM + VTD Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases
    Interventions:
    • Drug: Interim/Maintenance Dexamethasone
    • Drug: Induction/Consolidation Dexamethasone
    • Drug: Induction/Consolidation Cisplatin
    • Drug: Induction/Consolidation Adriamycin
    • Drug: InductionConsolidation Cyclophosphamide
    • Drug: Induction/Consolidation Etoposide
    • Drug: Induction Pegfilgrastim
    • Drug: Transplant 1 Dexamethasone
    • Drug: Transplant 1 Cisplatin
    • Drug: Transplant 1 Adriamycin
    • Drug: Transplant 1 Cyclophosphamide
    • Drug: Transplant 1 Etoposide
    • Drug: Transplant 1 Melphalan
    • Drug: Transplant 1 and 2 Pegfilgrastim
    • Procedure: Autologous Peripheral Blood Stem Cell Transplant (ASCT)
    • Drug: Transplant 2 Carmustine
    • Drug: Transplant 2 Etoposide
    • Drug: Transplant 2 Cytarabine
    • Drug: Transplant 2 Melphalan
    • Drug: Transplant 2 Dexamethasone
    • Drug: Transplant 1 and 2 Bortezomib
    • Drug: Transplant 1 and 2 Thalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 1, 2011)
20
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2007)
252
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00574080
Other Study ID Numbers  ICMJE 2006-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frits van Rhee, MD, PhD University of Arkansas
PRS Account University of Arkansas
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP