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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

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma 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 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: Arm A
DPACE Induction, Melphalan/DPACE Transplant 1, BEAM Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases
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

Experimental: Arm B
DPACE Induction, Melphalan/DPACE + VTD Transplant 1, BEAM + VTD Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases
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




Primary Outcome Measures :
  1. Event Free Survival [ Time Frame: Up to 3 years 8 months ]
    Time from study registration until disease progression or death.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574080


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Frits van Rhee, MD, PhD University of Arkansas

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00574080     History of Changes
Other Study ID Numbers: 2006-15
First Posted: December 14, 2007    Key Record Dates
Results First Posted: June 30, 2011
Last Update Posted: November 20, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Hemostatic Disorders
Doxorubicin
Liposomal doxorubicin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cisplatin
Dexamethasone
Cyclophosphamide
Etoposide
Etoposide phosphate
Bortezomib
Cytarabine
Melphalan
Thalidomide
Carmustine
Dexamethasone acetate
BB 1101
Antineoplastic Agents
Anti-Inflammatory Agents