Multiple MyelomaPhase 3NCT00574080
UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide
A Phase 3 study testing Interim/Maintenance Dexamethasone, Induction/Consolidation Dexamethasone and Induction/Consolidation Cisplatin in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Interim/Maintenance Dexamethasone, Induction/Consolidation Dexamethasone and Induction/Consolidation Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Mar 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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
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.
- Conditions
- Multiple Myeloma
- Being tested
- Interim/Maintenance Dexamethasone, Induction/Consolidation Dexamethasone, Induction/Consolidation Cisplatin, Induction/Consolidation Adriamycin, InductionConsolidation Cyclophosphamide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interim/Maintenance DexamethasoneDrug
Also called Dex, Dexamethasone acetate
20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
Induction/Consolidation DexamethasoneDrug
Also called Dex, Dexamethasone acetate
40 mg Days 1-4
Induction/Consolidation CisplatinDrug
10 mg/m2 by continuous infusion Days 1-4
Induction/Consolidation AdriamycinDrug
10 mg/m2 by continuous infusion Days 1-4
InductionConsolidation CyclophosphamideDrug
400 mg/m2 by continuous infusion Days 1-4
Induction/Consolidation EtoposideDrug
40 mg/m2 by continuous infusion Days 1-4
Induction PegfilgrastimDrug
6 mg Days 6 and 13
Transplant 1 DexamethasoneDrug
20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
Transplant 1 CisplatinDrug
20 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 AdriamycinDrug
20 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 CyclophosphamideDrug
800 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 EtoposideDrug
80 mg/m2 by continuous infusion Days -3 and -2
Transplant 1 MelphalanDrug
50 mg/m2 Days -2 and -1
Transplant 1 and 2 PegfilgrastimDrug
6 mg Day +6
Autologous Peripheral Blood Stem Cell Transplant (ASCT)Procedure or surgery
Day 0
Transplant 2 CarmustineDrug
300 mg/m2 Day -5
Transplant 2 EtoposideDrug
200 mg/m2 Days -5, -4, -3, -2
Transplant 2 CytarabineDrug
Also called Ara-C
400 mg/m2 Days -5, -4, -3, -2
Transplant 2 MelphalanDrug
140 mg/m2 Day -1
Transplant 2 DexamethasoneDrug
20 mg Days -5, -4, -3, -2, +4, +5, +6, +7
Transplant 1 and 2 BortezomibDrug
Also called Velcade
1 mg/m2 Days -4, -1, +3, +7
Transplant 1 and 2 ThalidomideDrug
200 mg Days -4 to +5
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | DPACE Induction, Melphalan/DPACE Transplant 1, BEAM Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases Receives: 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 |
| Arm B | Experimental | DPACE Induction, Melphalan/DPACE + VTD Transplant 1, BEAM + VTD Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival
Time from study registration until disease progression or death.
Measured: Up to 3 years 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startJul 2006
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frits van Rhee, MD, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574080
- Sponsor's protocol ID
- 2006-15
- Status last verified
- Oct 2017
- First submitted
- 12 Dec 2007
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00574080
- Acronym / sponsor ID
- 2006-15
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Posted 30 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | 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 DexamethasoneDPACE Induction, Melphalan/DPACE Transplant 1, BEAM Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases |
| Arm B | Experimental | 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 ThalidomideDPACE Induction, Melphalan/DPACE + VTD Transplant 1, BEAM + VTD Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interim/Maintenance DexamethasoneAlso: Dex, Dexamethasone acetate20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance | Drug | Arm A, Arm B |
| Induction/Consolidation DexamethasoneAlso: Dex, Dexamethasone acetate40 mg Days 1-4 | Drug | Arm A, Arm B |
| Induction/Consolidation Cisplatin10 mg/m2 by continuous infusion Days 1-4 | Drug | Arm A, Arm B |
| Induction/Consolidation Adriamycin10 mg/m2 by continuous infusion Days 1-4 | Drug | Arm A, Arm B |
| InductionConsolidation Cyclophosphamide400 mg/m2 by continuous infusion Days 1-4 | Drug | Arm A, Arm B |
| Induction/Consolidation Etoposide40 mg/m2 by continuous infusion Days 1-4 | Drug | Arm A, Arm B |
| Induction Pegfilgrastim6 mg Days 6 and 13 | Drug | Arm A, Arm B |
| Transplant 1 Dexamethasone20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7 | Drug | Arm A, Arm B |
| Transplant 1 Cisplatin20 mg/m2 by continuous infusion Days -3 and -2 | Drug | Arm A, Arm B |
| Transplant 1 Adriamycin20 mg/m2 by continuous infusion Days -3 and -2 | Drug | Arm A, Arm B |
| Transplant 1 Cyclophosphamide800 mg/m2 by continuous infusion Days -3 and -2 | Drug | Arm A, Arm B |
| Transplant 1 Etoposide80 mg/m2 by continuous infusion Days -3 and -2 | Drug | Arm A, Arm B |
| Transplant 1 Melphalan50 mg/m2 Days -2 and -1 | Drug | Arm A, Arm B |
| Transplant 1 and 2 Pegfilgrastim6 mg Day +6 | Drug | Arm A, Arm B |
| Autologous Peripheral Blood Stem Cell Transplant (ASCT)Day 0 | Procedure or surgery | Arm A, Arm B |
| Transplant 2 Carmustine300 mg/m2 Day -5 | Drug | Arm A, Arm B |
| Transplant 2 Etoposide200 mg/m2 Days -5, -4, -3, -2 | Drug | Arm A, Arm B |
| Transplant 2 CytarabineAlso: Ara-C400 mg/m2 Days -5, -4, -3, -2 | Drug | Arm A, Arm B |
| Transplant 2 Melphalan140 mg/m2 Day -1 | Drug | Arm A, Arm B |
| Transplant 2 Dexamethasone20 mg Days -5, -4, -3, -2, +4, +5, +6, +7 | Drug | Arm A, Arm B |
| Transplant 1 and 2 BortezomibAlso: Velcade1 mg/m2 Days -4, -1, +3, +7 | Drug | Arm B |
| Transplant 1 and 2 Thalidomide200 mg Days -4 to +5 | Drug | Arm B |
Primary outcome
Event Free Survival
Time frame: Up to 3 years 8 months
Time from study registration until disease progression or death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frits van Rhee, MD, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interim/Maintenance Dexamethasone, Induction/Consolidation Dexamethasone and Induction/Consolidation Cisplatin in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Free Survival (time frame: Up to 3 years 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.