Multiple MyelomaPhase 3NCT00573391
Study of Multiple Myeloma Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2
A Phase 3 study testing Velcade, Thalidomide, and Dexamethasone and Velcade, Melphalan, and Dexamethasone in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD). 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, and Dexamethasone and Velcade, Melphalan, and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2008
- 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
- History of histologically documented MM previously enrolled on UARK 98-026 with relapsed or progressive disease after at least one autologous transplant.
- Patient has measurable disease in which to capture response, defined as:
- Serum M-protein level > 1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis
- Urinary M-protein excretion > 200 mg/24 hrs
- Bone marrow plasmacytosis of > 30percent by bone marrow aspirate and/or biopsy
- Serum Free Light Chains (By the Freelite test) > 10 mg/dL with an abnormal kappa/lambda ration.
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- 50percent increase in size of lytic and/or focal lesions or development of new lesions recognized by radiographic studies.
- Performance status of 2 as per SWOG scale, unless PS of 3-4 based solely on bone pain.
- Patients must have a platelet count 50,000/mm3, unless the low platelet count is due to documented (>30 percent) extensive myeloma infiltration of the bone marrow.
- Patients must have adequate renal function defined as serum creatinine < 2.5 mg/dl.
- Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 2 x the upper limit of normal.
- Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Male or female adults of at least 18 years of age.
- Patients must have signed and IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations
- > 5 x 106 CD34 cells/kg in storage strongly desired, but not mandated
Who cannot join
- Not previously enrolled on UARK 98-026.
- Has received salvage therapy after coming off UARK 98-026.
- Evidence of POEMS Syndrome..
- Significant neurotoxicity interfering with ADL.
- Platelet count < 50,000/mm3
- Clinically significant hepatic dysfunction as noted by 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.
- Truly non-secretory MM (no increase in serum free-light chains) in the absence of bone marrow plasmacytosis and MRI-defined focal lesions with CT-FNA-proven MM
- Uncontrolled, active infection requiring IV antibiotics.
- Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
- Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
- Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method. Pregnancy testing will be performed prior to administration of each dose of study drug.
- Breast-feeding women may not participate.
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: A Phase III Study for Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2 (TT2, UARK 98-026): Bortezomib, Thalidomide and Dexamethasone Versus Bortezomib, Melphalan, and Dexamethasone
This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).
Read the detailed description
A new drug (bortezomib [VelcadeTM PS-341]) has been shown in recent studies to be effective in subjects with advanced multiple myeloma. There is also research that shows this drug may be even more effective when used in combination with other drugs that have been used to treat myeloma for many years (melphalan, thalidomide, and dexamethasone). This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).
- Conditions
- Multiple Myeloma
- Being tested
- Velcade, Thalidomide, and Dexamethasone, Velcade, Melphalan, and Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velcade, Thalidomide, and DexamethasoneDrug
Velcade - Into vein (IV) Days 1, 4, 8, 11
Yr 1: Every 28-35 days-12 cycles
Yr 2: Every 8-10 weeks- 6 cycles
Thalidomide - By Mouth Days 1-28
Yr 1: Every 28-35 days-12 cycles
Yr 2: Every 8-10 weeks- 6 cycles
Velcade, Melphalan, and DexamethasoneDrug
Velcade - Into vein (IV) Days 1, 4, 8, 11
Yr 1: Every 28-35 days-12 cycles
Yr 2: Every 8-10 weeks- 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| VTD = Velcade, Thal, and Dex | Experimental | VTD = Velcade, Thalidomide, and Dexamethasone Receives: Drug: Velcade, Thalidomide, and Dexamethasone |
| VMD = velcade, melphalan, and dex | Experimental | VMD = velcade, melphalan, and dexamethasone Receives: Drug: Velcade, Melphalan, and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Survival With Velcade/Melphalan/Dexamethasone Treatment vs. Participant Survival With Velcade/Thalidomide/Dexamethasone Treatment
due to low accrual rates, no analyses was done to compare the new combination of Velcade/Melphalan/Dexamethasone vs. Velcade/Thalidomide/Dexamethasone
Measured: 24 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 startAug 2006
- Primary completionJul 2008
- Study completionJul 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Investigators
- Bart Barlogie, MD, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573391
- Sponsor's protocol ID
- 2006-05
- Status last verified
- Jul 2011
- First submitted
- 12 Dec 2007
- Last updated
- 12 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Usmani SZ, Sexton R, Hoering A, Heuck CJ, Nair B, Waheed S, Al Sayed Y, Chauhan N, Ahmad N, Atrash S, Petty N, van Rhee F, Crowley J, Barlogie B. Second malignancies in total therapy 2 and 3 for newly diagnosed multiple myeloma: influence of thalidomide and lenalidomide during maintenance. Blood. 2012 Aug 23;120(8):1597-600. doi: 10.1182/blood-2012-04-421883. Epub 2012 Jun 6.
PubMed 22674807
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study for Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2 (TT2, UARK 98-026): Bortezomib, Thalidomide and Dexamethasone Versus Bortezomib, Melphalan, and Dexamethasone
- ClinicalTrials.gov ID
- NCT00573391
- Acronym / sponsor ID
- 2006-05
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Posted 12 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).
Detailed description
A new drug (bortezomib [VelcadeTM PS-341]) has been shown in recent studies to be effective in subjects with advanced multiple myeloma. There is also research that shows this drug may be even more effective when used in combination with other drugs that have been used to treat myeloma for many years (melphalan, thalidomide, and dexamethasone). This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VTD = Velcade, Thal, and Dex | Experimental | Drug: Velcade, Thalidomide, and DexamethasoneVTD = Velcade, Thalidomide, and Dexamethasone |
| VMD = velcade, melphalan, and dex | Experimental | Drug: Velcade, Melphalan, and DexamethasoneVMD = velcade, melphalan, and dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- History of histologically documented MM previously enrolled on UARK 98-026 with relapsed or progressive disease after at least one autologous transplant.
- Patient has measurable disease in which to capture response, defined as:
- Serum M-protein level > 1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis
- Urinary M-protein excretion > 200 mg/24 hrs
- Bone marrow plasmacytosis of > 30percent by bone marrow aspirate and/or biopsy
Key exclusion criteria (14 listed)
- Not previously enrolled on UARK 98-026.
- Has received salvage therapy after coming off UARK 98-026.
- Evidence of POEMS Syndrome..
- Significant neurotoxicity interfering with ADL.
- Platelet count < 50,000/mm3
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, and DexamethasoneVelcade - Into vein (IV) Days 1, 4, 8, 11 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles Thalidomide - By Mouth Days 1-28 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles | Drug | VTD = Velcade, Thal, and Dex |
| Velcade, Melphalan, and DexamethasoneVelcade - Into vein (IV) Days 1, 4, 8, 11 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles | Drug | VMD = velcade, melphalan, and dex |
Primary outcome
Participant Survival With Velcade/Melphalan/Dexamethasone Treatment vs. Participant Survival With Velcade/Thalidomide/Dexamethasone Treatment
Time frame: 24 months
due to low accrual rates, no analyses was done to compare the new combination of Velcade/Melphalan/Dexamethasone vs. Velcade/Thalidomide/Dexamethasone
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22674807Usmani SZ, Sexton R, Hoering A, Heuck CJ, Nair B, Waheed S, Al Sayed Y, Chauhan N, Ahmad N, Atrash S, Petty N, van Rhee F, Crowley J, Barlogie B. Second malignancies in total therapy 2 and 3 for newly diagnosed multiple myeloma: influence of thalidomide and lenalidomide during maintenance. Blood. 2012 Aug 23;120(8):1597-600. doi: 10.1182/blood-2012-04-421883. Epub 2012 Jun 6.
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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.
Bart Barlogie, 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 Velcade, Thalidomide, and Dexamethasone and Velcade, Melphalan, and 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 15 inclusion and 14 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 12 Aug 2011. 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 12 Aug 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?
Participant Survival With Velcade/Melphalan/Dexamethasone Treatment vs. Participant Survival With Velcade/Thalidomide/Dexamethasone Treatment (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00573391, which also lists 1 linked publication.
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 12 Aug 2011.