- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00574080
UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide
October 17, 2017 updated by: University of Arkansas
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
- 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
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
Other Names:
40 mg Days 1-4
Other Names:
10 mg/m2 by continuous infusion Days 1-4
10 mg/m2 by continuous infusion Days 1-4
400 mg/m2 by continuous infusion Days 1-4
40 mg/m2 by continuous infusion Days 1-4
6 mg Days 6 and 13
20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
20 mg/m2 by continuous infusion Days -3 and -2
20 mg/m2 by continuous infusion Days -3 and -2
800 mg/m2 by continuous infusion Days -3 and -2
80 mg/m2 by continuous infusion Days -3 and -2
50 mg/m2 Days -2 and -1
6 mg Day +6
Day 0
300 mg/m2 Day -5
200 mg/m2 Days -5, -4, -3, -2
400 mg/m2 Days -5, -4, -3, -2
Other Names:
140 mg/m2 Day -1
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
|
20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
Other Names:
40 mg Days 1-4
Other Names:
10 mg/m2 by continuous infusion Days 1-4
10 mg/m2 by continuous infusion Days 1-4
400 mg/m2 by continuous infusion Days 1-4
40 mg/m2 by continuous infusion Days 1-4
6 mg Days 6 and 13
20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
20 mg/m2 by continuous infusion Days -3 and -2
20 mg/m2 by continuous infusion Days -3 and -2
800 mg/m2 by continuous infusion Days -3 and -2
80 mg/m2 by continuous infusion Days -3 and -2
50 mg/m2 Days -2 and -1
6 mg Day +6
Day 0
300 mg/m2 Day -5
200 mg/m2 Days -5, -4, -3, -2
400 mg/m2 Days -5, -4, -3, -2
Other Names:
140 mg/m2 Day -1
20 mg Days -5, -4, -3, -2, +4, +5, +6, +7
1 mg/m2 Days -4, -1, +3, +7
Other Names:
200 mg Days -4 to +5
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event Free Survival
Time Frame: Up to 3 years 8 months
|
Time from study registration until disease progression or death.
|
Up to 3 years 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frits van Rhee, MD, PhD, University of Arkansas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
December 12, 2007
First Submitted That Met QC Criteria
December 13, 2007
First Posted (Estimate)
December 14, 2007
Study Record Updates
Last Update Posted (Actual)
November 20, 2017
Last Update Submitted That Met QC Criteria
October 17, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Antibiotics, Antineoplastic
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Cyclophosphamide
- Etoposide
- Etoposide phosphate
- Cisplatin
- Thalidomide
- Melphalan
- Bortezomib
- Doxorubicin
- Liposomal doxorubicin
- Cytarabine
- Carmustine
Other Study ID Numbers
- 2006-15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
-
Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
-
National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on Interim/Maintenance Dexamethasone
-
Rambam Health Care CampusCompletedClassical Hodgkin Lymphoma | Nodular Sclerosis | Mixed Cellularity | Lymphocyte Depletion | Lymphocyte RichIsrael
-
Barwon HealthNational Health and Medical Research Council, Australia; University of MelbourneCompleted
-
Milton S. Hershey Medical CenterNational Institutes of Health (NIH); National Institute on Aging (NIA)Enrolling by invitationOverweight and Obesity | Walking | Physical Inactivity | Self-regulation | Cognitive HealthUnited States
-
Hee Young JuNot yet recruitingLymphoblastic Leukemia in Children
-
Kaiser PermanenteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American...Completed
-
VA Office of Research and DevelopmentBaltimore VA Medical Center; South Texas Veterans Health Care SystemRecruiting
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic Obstructive
-
The Catholic University of KoreaActive, not recruitingLymphoma, Large B-Cell, DiffuseKorea, Republic of
-
Vanderbilt University Medical CenterRecruitingBreast CancerUnited States
-
Eunice Kennedy Shriver National Institute of Child...Completed