Multiple MyelomaPhase 2NCT00577668
A Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD)
A Phase 2 study testing Melphalan, Velcade, Thalidomide, Dexamethasone in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
In this study, researchers want to find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s). 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?
- Melphalan, Velcade, Thalidomide, Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2009
- Phase
- Phase 2
- 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
- History of histologically documented MM with relapsed or progressive disease after either scheduled tandem or one autologous transplantation.
- Patient has measurable disease in which to capture response.
- Performance status of 2 as per Zubroid scale, unless PS of 3-4 based solely on bone pain.
- Patients must have a platelet count 75,000/μL, and an ANC of at least 1,000/μL.
- 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.
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- 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 an IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations.
Who cannot join
- Chemotherapy or radiotherapy received within the previous 2 weeks.
- Significant neurotoxicity, defined as grade > 2 neurotoxicity per NCI Common Toxicity Criteria (See Appendix).
- Platelet count < 75,000/mm3, or ANC < 1,000/μl.
- Clinically significant hepatic dysfunction as noted by 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.
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- 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.
- 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: UARK 2007-01, A Phase II Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD) and Autologous Transplantation for Patients Relapsing or Progressing After Tandem Transplantation
In this study, researchers want to find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s).
Read the detailed description
Autologous transplant is now considered a standard treatment for many patients with multiple myeloma. An autologous transplant is a procedure in which stem cells are removed from a patient and then given back to the patient following intensive treatment. Doctors remove healthy stem cells from a patient's circulating blood system and store them before the patient receives high-dose chemotherapy. The stem cells are then returned to the patient, where they can produce new blood cells to replace cells destroyed by the treatment. The drug usually used before transplant is melphalan alone in 1 or 2 high doses. In past studies conducted at UAMS, researchers have shown that a chemotherapy treatment regimen called "VTD" is effective in patients with multiple myeloma who have failed previous treatments. VTD is a combination of drugs consisting of VelcadeTM (also known as bortezomib), Thalidomide, and Dexamethasone. In this study, researchers want to find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s) can be given safely to subjects who have failed previous transplant(s).
- Conditions
- Multiple Myeloma
- Being tested
- Melphalan, Velcade, Thalidomide, 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.
Melphalan, Velcade, Thalidomide, DexamethasoneDrug
To assess, in patients with one or two prior auto transplants, the efficacy of a high-dose combination chemotherapy with MEL 300 (in 3 fractions of 100 mg/m2 on days -7, -4, -1) plus VTD (Velcade = bortezomib 1.3 mg/m2 on days -7, -4, -1; Thalidomide 200 mg/d on days -1 through -7; Dexamethasone 40 mg on days -7, -6, -4, -3, -1, 0) followed by autologous peripheral blood stem cell (PBSC) infusion of a minimum dose of 3 million CD34 cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| VDT and Melphalan | Experimental | To find out if three drugs, bortezomib, thalidomide, and dexamethasone in addition to high doses of melphalan (M-VTD) and autologous transplant can be given safely and effectively to subjects who have failed previous regimens with transplant(s). Receives: Drug: Melphalan, Velcade, Thalidomide, Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTD regimen with melphalan
To find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Poor accrual
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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Investigators
- Mauricio Pineda-Roman, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577668
- Sponsor's protocol ID
- 2007-01
- Status last verified
- May 2011
- First submitted
- 18 Dec 2007
- Last updated
- 3 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UARK 2007-01, A Phase II Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD) and Autologous Transplantation for Patients Relapsing or Progressing After Tandem Transplantation
- ClinicalTrials.gov ID
- NCT00577668
- Acronym / sponsor ID
- 2007-01
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Dec 2007 (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.
In this study, researchers want to find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s).
Detailed description
Autologous transplant is now considered a standard treatment for many patients with multiple myeloma. An autologous transplant is a procedure in which stem cells are removed from a patient and then given back to the patient following intensive treatment. Doctors remove healthy stem cells from a patient's circulating blood system and store them before the patient receives high-dose chemotherapy. The stem cells are then returned to the patient, where they can produce new blood cells to replace cells destroyed by the treatment. The drug usually used before transplant is melphalan alone in 1 or 2 high doses. In past studies conducted at UAMS, researchers have shown that a chemotherapy treatment regimen called "VTD" is effective in patients with multiple myeloma who have failed previous treatments. VTD is a combination of drugs consisting of VelcadeTM (also known as bortezomib), Thalidomide, and Dexamethasone. In this study, researchers want to find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s) can be given safely to subjects who have failed previous transplant(s).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VDT and Melphalan | Experimental | Drug: Melphalan, Velcade, Thalidomide, DexamethasoneTo find out if three drugs, bortezomib, thalidomide, and dexamethasone in addition to high doses of melphalan (M-VTD) and autologous transplant can be given safely and effectively to subjects who have failed previous regimens with transplant(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- History of histologically documented MM with relapsed or progressive disease after either scheduled tandem or one autologous transplantation.
- Patient has measurable disease in which to capture response.
- Performance status of 2 as per Zubroid scale, unless PS of 3-4 based solely on bone pain.
- Patients must have a platelet count 75,000/μL, and an ANC of at least 1,000/μL.
- Patients must have adequate renal function defined as serum creatinine < 2.5 mg/dL.
Key exclusion criteria (11 listed)
- Chemotherapy or radiotherapy received within the previous 2 weeks.
- Significant neurotoxicity, defined as grade > 2 neurotoxicity per NCI Common Toxicity Criteria (See Appendix).
- Platelet count < 75,000/mm3, or ANC < 1,000/μl.
- Clinically significant hepatic dysfunction as noted by 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.
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 |
|---|---|---|
| Melphalan, Velcade, Thalidomide, DexamethasoneTo assess, in patients with one or two prior auto transplants, the efficacy of a high-dose combination chemotherapy with MEL 300 (in 3 fractions of 100 mg/m2 on days -7, -4, -1) plus VTD (Velcade = bortezomib 1.3 mg/m2 on days -7, -4, -1; Thalidomide 200 mg/d on days -1 through -7; Dexamethasone 40 mg on days -7, -6, -4, -3, -1, 0) followed by autologous peripheral blood stem cell (PBSC) infusion of a minimum dose of 3 million CD34 cells/kg. | Drug | VDT and Melphalan |
Primary outcome
VTD regimen with melphalan
Time frame: 12 months
To find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2011.
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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.
Mauricio Pineda-Roman, 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 2 study testing Melphalan, 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 9 inclusion and 11 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: withdrawn, as of the sponsor's last update on 3 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
VTD regimen with melphalan (time frame: 12 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 3 May 2011.