UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide
NCT ID: NCT00574080
Last Updated: 2017-11-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
20 participants
INTERVENTIONAL
2006-07-31
2011-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
DPACE Induction, Melphalan/DPACE Transplant 1, BEAM Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases
Interim/Maintenance Dexamethasone
20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
Induction/Consolidation Dexamethasone
40 mg Days 1-4
Induction/Consolidation Cisplatin
10 mg/m2 by continuous infusion Days 1-4
Induction/Consolidation Adriamycin
10 mg/m2 by continuous infusion Days 1-4
InductionConsolidation Cyclophosphamide
400 mg/m2 by continuous infusion Days 1-4
Induction/Consolidation Etoposide
40 mg/m2 by continuous infusion Days 1-4
Induction Pegfilgrastim
6 mg Days 6 and 13
Transplant 1 Dexamethasone
20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
Transplant 1 Cisplatin
20 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Adriamycin
20 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Cyclophosphamide
800 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Etoposide
80 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Melphalan
50 mg/m2 Days -2 and -1
Transplant 1 and 2 Pegfilgrastim
6 mg Day +6
Autologous Peripheral Blood Stem Cell Transplant (ASCT)
Day 0
Transplant 2 Carmustine
300 mg/m2 Day -5
Transplant 2 Etoposide
200 mg/m2 Days -5, -4, -3, -2
Transplant 2 Cytarabine
400 mg/m2 Days -5, -4, -3, -2
Transplant 2 Melphalan
140 mg/m2 Day -1
Transplant 2 Dexamethasone
20 mg Days -5, -4, -3, -2, +4, +5, +6, +7
Arm B
DPACE Induction, Melphalan/DPACE + VTD Transplant 1, BEAM + VTD Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases
Interim/Maintenance Dexamethasone
20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
Induction/Consolidation Dexamethasone
40 mg Days 1-4
Induction/Consolidation Cisplatin
10 mg/m2 by continuous infusion Days 1-4
Induction/Consolidation Adriamycin
10 mg/m2 by continuous infusion Days 1-4
InductionConsolidation Cyclophosphamide
400 mg/m2 by continuous infusion Days 1-4
Induction/Consolidation Etoposide
40 mg/m2 by continuous infusion Days 1-4
Induction Pegfilgrastim
6 mg Days 6 and 13
Transplant 1 Dexamethasone
20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
Transplant 1 Cisplatin
20 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Adriamycin
20 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Cyclophosphamide
800 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Etoposide
80 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Melphalan
50 mg/m2 Days -2 and -1
Transplant 1 and 2 Pegfilgrastim
6 mg Day +6
Autologous Peripheral Blood Stem Cell Transplant (ASCT)
Day 0
Transplant 2 Carmustine
300 mg/m2 Day -5
Transplant 2 Etoposide
200 mg/m2 Days -5, -4, -3, -2
Transplant 2 Cytarabine
400 mg/m2 Days -5, -4, -3, -2
Transplant 2 Melphalan
140 mg/m2 Day -1
Transplant 2 Dexamethasone
20 mg Days -5, -4, -3, -2, +4, +5, +6, +7
Transplant 1 and 2 Bortezomib
1 mg/m2 Days -4, -1, +3, +7
Transplant 1 and 2 Thalidomide
200 mg Days -4 to +5
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Interim/Maintenance Dexamethasone
20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
Induction/Consolidation Dexamethasone
40 mg Days 1-4
Induction/Consolidation Cisplatin
10 mg/m2 by continuous infusion Days 1-4
Induction/Consolidation Adriamycin
10 mg/m2 by continuous infusion Days 1-4
InductionConsolidation Cyclophosphamide
400 mg/m2 by continuous infusion Days 1-4
Induction/Consolidation Etoposide
40 mg/m2 by continuous infusion Days 1-4
Induction Pegfilgrastim
6 mg Days 6 and 13
Transplant 1 Dexamethasone
20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
Transplant 1 Cisplatin
20 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Adriamycin
20 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Cyclophosphamide
800 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Etoposide
80 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 Melphalan
50 mg/m2 Days -2 and -1
Transplant 1 and 2 Pegfilgrastim
6 mg Day +6
Autologous Peripheral Blood Stem Cell Transplant (ASCT)
Day 0
Transplant 2 Carmustine
300 mg/m2 Day -5
Transplant 2 Etoposide
200 mg/m2 Days -5, -4, -3, -2
Transplant 2 Cytarabine
400 mg/m2 Days -5, -4, -3, -2
Transplant 2 Melphalan
140 mg/m2 Day -1
Transplant 2 Dexamethasone
20 mg Days -5, -4, -3, -2, +4, +5, +6, +7
Transplant 1 and 2 Bortezomib
1 mg/m2 Days -4, -1, +3, +7
Transplant 1 and 2 Thalidomide
200 mg Days -4 to +5
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Arkansas
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frits van Rhee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-15
Identifier Type: -
Identifier Source: org_study_id