Multiple MyelomaPhase 3NCT00111748
UARK 2005-01 Study of Velcade, Thalidomide, and Dexamethasone (VTD) With or Without Adriamycin® in Relapsed/Refractory Patients
A Phase 3 study testing Velcade, Thalidomide, Dexamethasone in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
The main goal of this study is to evaluate the effectiveness of the combination of these drugs, and whether they can be given safely together. 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?
- Velcade, Thalidomide, Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 relapsing multiple myeloma (MM)
- Patients must have adequate platelet count of > 20,000 x 10^9/L, independent of transfusions, unless it is due to massive myeloma infiltration.
- Anticipated life expectancy of at least 3 months
- Ejection fraction by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan performed within 60 days prior to registration; left ventricular ejection fraction (LVEF) > 40% by ECHO or MUGA.
- Female patients of child bearing age are required to have a negative pregnancy test as indicated in thalidomide safety guidelines
- Patients must have a performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
- All patients must be informed of the investigational nature of this study and must have signed an institutional review board (IRB)-approved informed consent in accordance with institutional and federal guidelines.
Who cannot join
- Evidence of central nervous system (CNS) involvement
- Grade > 2 peripheral neuropathy
- Hypersensitivity to Velcade, boron, or mannitol
- Recent (< 6 months) myocardial infarction, cerebrovascular accident (CVA)/stroke, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
- Evidence of chronic obstructive or chronic restrictive pulmonary disease.
- Prior malignancy, 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.
- Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
- Pregnant or nursing women. Women of child-bearing potential must have a negative pregnancy test documented within one week of registration. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment.
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 2005-01, A Phase III Study of Velcade, Thalidomide, and Dexamethasone (VTD) With or Without Adriamycin® in Relapsed/Refractory Patients
The main goal of this study is to evaluate the effectiveness of the combination of these drugs, and whether they can be given safely together.
Read the detailed description
In this study, there will be two arms (or groups). One arm will receive Velcade, thalidomide, and dexamethasone (VTD), and the other arm will receive VTD with Adriamycin.
This study has the following specific goal:
To evaluate the efficacy and toxicity of two treatments in multiple myeloma patients, relapsing after at least one course of high-dose treatment and an autologous stem cell transplant, or after at least two lines of conventional chemotherapy.
- Conditions
- Multiple Myeloma
- Being tested
- Velcade, Thalidomide, Dexamethasone
- Keywords
- Myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velcade, Thalidomide, DexamethasoneDrug
Dosage and Administration Schedule Each cycle will consist of 3 weeks (21 days). AGENT DOSE ROUTE DAYS Velcade 1.0 mg/m2 IV 1, 4, 8, and 11 Thalidomide 100 mg PO Daily, hs Dexamethasone 20 mg PO Days 1, 2, 4,5, 8, 9, 11, 12 Lovenox 40 mg SQ Days 1-14
This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). The next cycle of treatment may be delayed up to day 29 due to non-toxicity reasons. Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a maximum of eight cycles. At the discretion of the treating physician, patients may be eligible to receive treatment at their local physician after completion of the 1st cycle. These patients will need to return to MIRT prior to every cycle for cycles 2-4, cycles 6 and 8, and final visit.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Stratification:
1. CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis
2. Prior Velcade vs. No prior Velcade
TREATMENT:VTD Velcade 1.0 mg/m2 Days 1,4, 8,11 Thalidomide 100 mg Daily qhs Dexamethasone 20 mg Days 1, 2, 4,5, 8, 9, 11, 12 Lovenox 40 mg Days 1-14 Every 21 days Receives: Drug: Velcade, Thalidomide, Dexamethasone |
| 2 | Active comparator | Stratification:
1. CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis
2. Prior Velcade vs. No prior Velcade
TREATMENT:
VATD Velcade 1.0 mg/m2 Days 1,4, 8,11 Thalidomide 100 mg Daily qhs Dexamethasone 20 mg Days 1, 2, 4,5, 8, 9, 11, 12 Adriamycin 2.5 mg/m2 Days 1-4 \& Days 9-12 Lovenox 40 mg Days 1-14 Every 21 days Receives: Drug: Velcade, Thalidomide, Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of the combination of these drugs
Measured: 168 days
Secondary outcomes (1)
Evaluate the efficacy and toxicity of two treatments in multiple myeloma patients, relapsing after at least one course of high-dose treatment and an autologous stem cell transplant
Measured: 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2005 (estimated)
- Study startFeb 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Investigators
- Klaus Hollmig, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111748
- Sponsor's protocol ID
- 29432
- Status last verified
- Oct 2015
- First submitted
- 24 May 2005
- Last updated
- 6 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UARK 2005-01, A Phase III Study of Velcade, Thalidomide, and Dexamethasone (VTD) With or Without Adriamycin® in Relapsed/Refractory Patients
- ClinicalTrials.gov ID
- NCT00111748
- Acronym / sponsor ID
- 29432
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 25 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to evaluate the effectiveness of the combination of these drugs, and whether they can be given safely together.
Detailed description
In this study, there will be two arms (or groups). One arm will receive Velcade, thalidomide, and dexamethasone (VTD), and the other arm will receive VTD with Adriamycin.
This study has the following specific goal:
To evaluate the efficacy and toxicity of two treatments in multiple myeloma patients, relapsing after at least one course of high-dose treatment and an autologous stem cell transplant, or after at least two lines of conventional chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Velcade, Thalidomide, DexamethasoneStratification: 1. CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis 2. Prior Velcade vs. No prior Velcade TREATMENT:VTD Velcade 1.0 mg/m2 Days 1,4, 8,11 Thalidomide 100 mg Daily qhs Dexamethasone 20 mg Days 1, 2, 4,5, 8, 9, 11, 12 Lovenox 40 mg Days 1-14 Every 21 days |
| 2 | Active comparator | Drug: Velcade, Thalidomide, DexamethasoneStratification: 1. CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis 2. Prior Velcade vs. No prior Velcade TREATMENT: VATD Velcade 1.0 mg/m2 Days 1,4, 8,11 Thalidomide 100 mg Daily qhs Dexamethasone 20 mg Days 1, 2, 4,5, 8, 9, 11, 12 Adriamycin 2.5 mg/m2 Days 1-4 \& Days 9-12 Lovenox 40 mg Days 1-14 Every 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with relapsing multiple myeloma (MM)
- Patients must have adequate platelet count of > 20,000 x 10^9/L, independent of transfusions, unless it is due to massive myeloma infiltration.
- Anticipated life expectancy of at least 3 months
- Ejection fraction by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan performed within 60 days prior to registration; left ventricular ejection fraction (LVEF) > 40% by ECHO or MUGA.
- Female patients of child bearing age are required to have a negative pregnancy test as indicated in thalidomide safety guidelines
Key exclusion criteria (8 listed)
- Evidence of central nervous system (CNS) involvement
- Grade > 2 peripheral neuropathy
- Hypersensitivity to Velcade, boron, or mannitol
- Recent (< 6 months) myocardial infarction, cerebrovascular accident (CVA)/stroke, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
- Evidence of chronic obstructive or chronic restrictive pulmonary disease.
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 |
|---|---|---|
| Velcade, Thalidomide, DexamethasoneDosage and Administration Schedule Each cycle will consist of 3 weeks (21 days). AGENT DOSE ROUTE DAYS Velcade 1.0 mg/m2 IV 1, 4, 8, and 11 Thalidomide 100 mg PO Daily, hs Dexamethasone 20 mg PO Days 1, 2, 4,5, 8, 9, 11, 12 Lovenox 40 mg SQ Days 1-14 This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). The next cycle of treatment may be delayed up to day 29 due to non-toxicity reasons. Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a maximum of eight cycles. At the discretion of the treating physician, patients may be eligible to receive treatment at their local physician after completion of the 1st cycle. These patients will need to return to MIRT prior to every cycle for cycles 2-4, cycles 6 and 8, and final visit. | Drug | 1, 2 |
Primary outcome
Evaluate the effectiveness of the combination of these drugs
Time frame: 168 days
1 secondary outcome
Evaluate the efficacy and toxicity of two treatments in multiple myeloma patients, relapsing after at least one course of high-dose treatment and an autologous stem cell transplant
Time frame: 168 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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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.
Klaus Hollmig, MD 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 Velcade, Thalidomide, Dexamethasone 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 6 Oct 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the effectiveness of the combination of these drugs (time frame: 168 days). 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 6 Oct 2015.