MULTIPLE MYELOMANCT00569868
UARK 2005-05, Coagulation-Related Effects of Velcade Treatment in Patients With Relapsed or Refractory Multiple Myeloma
A study testing Velcade in people with MULTIPLE MYELOMA, run by University of Arkansas at 1 site in United States.
Trial summary
To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MULTIPLE MYELOMA
- What is being tested?
- Velcade
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jan 2008
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with myeloma who had relapsed after one prior treatment and who have demonstrated resistance to their last treatment, who are candidate to receive Velcade and had normal PT and PTT, will be evaluated for inclusion in the present study.
Who cannot join
- Previous history of venous thromboembolism, myocardial infarction, stroke, TIA
- Hypercoagulable state (deficit ATIII, Factor V Leiden, deficit protein S, deficit protein C, prothrombin gene mutation), antiphospholipid syndrome.
- Von Willebrand disease, inherited platelet abnormalities.
- Familiar history of hypercoagulable state.
- Anticoagulant therapy, aspirin, non-steroidal anti-inflammatory drugs, beta blockers, tricyclic antidepressant, hormone replacement therapy, BCPs, and all other agents able to interfere with platelet function in the previous two weeks.
- Non-secretory MM, unless the patient has measurable lesions on CT, MRI and/or PET.
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
To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.
Read the detailed description
Cardiovascular complications during the treatment of patients with multiple myeloma are not uncommon, (10%) and the frequency clearly increases with the use of regimens containing thalidomide in combination with glucocorticosteroids or chemotherapy especially adriamycin. Even with prophylactic anticoagulation, DVT still occurs in 10% of such patients. The use of full anticoagulation raises considerable concern of bleeding especially during the post chemotherapy thrombocytopenic period. We observed no thromboembolic episodes when Velcade was added to thalidomide and adriamycin containing chemotherapy.
Therefore, we would like to investigate this protective antithrombotic effect of VELCADE in a malignancy associated with a hypercoagulable state in a group of 10 patients with Relapsed/Refractory Multiple Myeloma.
- Conditions
- MULTIPLE MYELOMA
- Being tested
- Velcade
- Keywords
- PLASMACYTOMA
- Medical subject headings
- Multiple Myeloma, Plasmacytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelcadeDrug
Except for the two PCR-based genotyping assays, which will be conducted only on baseline samples, tests will be assessed at baseline, 1-3 hours after the first dose of Velcade day 1 and on day 11 of the first cycle of Velcade.
The platelet Aggregation Test will be done only if Platelet count is 100 000.
| Study group | Role | What they receive |
|---|---|---|
| Velcade | Experimental | Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days. After you have gone off study, you will be followed every three months for approximately 2 years.
Each cycle will consist of 3 weeks (21 days) according to the schedule below.
DRUG ROUTE DOSE DAYS Velcade IV 1.3 mg/m2 1,4,8, and 11 This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a two cycles. Receives: Drug: Velcade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma.
Goal is to evaluate changes in coagulation (blood clotting) in refractory/relapsing multiple myeloma patients during VELCADE treatment.
Before and during treatment, participant will undergo routine tests/procedures following the Myeloma Institute's guidelines (physical exams, blood, urine, and bone tests, and bone marrow aspirates and biopsies) and will also receive a series of coagulation tests before treatment and after 1st and 3rd doses of each cycle.
Response measured as: complete, partial, or minimal response, no change, progressive disease, or relapse from complete response.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startAug 2005
- Primary completionJan 2008
- Study completionJan 2008
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 N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Investigators
- Maurizio Zangari, MD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569868
- Sponsor's protocol ID
- 2005-05
- Status last verified
- Jul 2011
- First submitted
- 7 Dec 2007
- Last updated
- 12 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zangari M, Yaccoby S, Pappas L, Cavallo F, Kumar NS, Ranganathan S, Suva LJ, Gruenwald JM, Kern S, Zhan F, Esseltine D, Tricot G. A prospective evaluation of the biochemical, metabolic, hormonal and structural bone changes associated with bortezomib response in multiple myeloma patients. Haematologica. 2011 Feb;96(2):333-6. doi: 10.3324/haematol.2010.031302. Epub 2010 Oct 15.
PubMed 20952514
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
- UARK 2005-05, Coagulation-Related Effects of Velcade Treatment in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00569868
- Acronym / sponsor ID
- 2005-05
- Conditions
- MULTIPLE MYELOMA
- Keywords
- PLASMACYTOMA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 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.
To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.
Detailed description
Cardiovascular complications during the treatment of patients with multiple myeloma are not uncommon, (10%) and the frequency clearly increases with the use of regimens containing thalidomide in combination with glucocorticosteroids or chemotherapy especially adriamycin. Even with prophylactic anticoagulation, DVT still occurs in 10% of such patients. The use of full anticoagulation raises considerable concern of bleeding especially during the post chemotherapy thrombocytopenic period. We observed no thromboembolic episodes when Velcade was added to thalidomide and adriamycin containing chemotherapy.
Therefore, we would like to investigate this protective antithrombotic effect of VELCADE in a malignancy associated with a hypercoagulable state in a group of 10 patients with Relapsed/Refractory Multiple Myeloma.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Velcade | Experimental | Drug: VelcadeTreatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days. After you have gone off study, you will be followed every three months for approximately 2 years. Each cycle will consist of 3 weeks (21 days) according to the schedule below. DRUG ROUTE DOSE DAYS Velcade IV 1.3 mg/m2 1,4,8, and 11 This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a two cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with myeloma who had relapsed after one prior treatment and who have demonstrated resistance to their last treatment, who are candidate to receive Velcade and had normal PT and PTT, will be evaluated for inclusion in the present study.
Key exclusion criteria (6 listed)
- Previous history of venous thromboembolism, myocardial infarction, stroke, TIA
- Hypercoagulable state (deficit ATIII, Factor V Leiden, deficit protein S, deficit protein C, prothrombin gene mutation), antiphospholipid syndrome.
- Von Willebrand disease, inherited platelet abnormalities.
- Familiar history of hypercoagulable state.
- Anticoagulant therapy, aspirin, non-steroidal anti-inflammatory drugs, beta blockers, tricyclic antidepressant, hormone replacement therapy, BCPs, and all other agents able to interfere with platelet function in the previous two weeks.
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 |
|---|---|---|
| VelcadeExcept for the two PCR-based genotyping assays, which will be conducted only on baseline samples, tests will be assessed at baseline, 1-3 hours after the first dose of Velcade day 1 and on day 11 of the first cycle of Velcade. The platelet Aggregation Test will be done only if Platelet count is 100 000. | Drug | Velcade |
Primary outcome
Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma.
Time frame: 60 days
Goal is to evaluate changes in coagulation (blood clotting) in refractory/relapsing multiple myeloma patients during VELCADE treatment. Before and during treatment, participant will undergo routine tests/procedures following the Myeloma Institute's guidelines (physical exams, blood, urine, and bone tests, and bone marrow aspirates and biopsies) and will also receive a series of coagulation tests before treatment and after 1st and 3rd doses of each cycle. Response measured as: complete, partial, or minimal response, no change, progressive disease, or relapse from complete response.
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 20952514Zangari M, Yaccoby S, Pappas L, Cavallo F, Kumar NS, Ranganathan S, Suva LJ, Gruenwald JM, Kern S, Zhan F, Esseltine D, Tricot G. A prospective evaluation of the biochemical, metabolic, hormonal and structural bone changes associated with bortezomib response in multiple myeloma patients. Haematologica. 2011 Feb;96(2):333-6. doi: 10.3324/haematol.2010.031302. Epub 2010 Oct 15.
- Myeloma Institute for Research and TherapyLink provided by the sponsor.
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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.
Maurizio Zangari, MD principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Velcade 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 1 inclusion and 6 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 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.
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?
Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma. (time frame: 60 days). 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 NCT00569868, 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.