Multiple MyelomaPhase 2NCT00128921
Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory Multiple Myeloma
A Phase 2 study testing VELCADE™ in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
Velcade (bortezomib, PS-341) has recently been approved by the Food and Drug Administration (FDA) for the treatment of multiple myeloma for patients who have received at least one prior therapy. Velcade is a unique compound developed by scientists at Millennium Pharmaceuticals, Inc. 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™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Feb 2008
- Phase
- Phase 2
- 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 with relapsed or progressive disease after at least one line of prior therapy.
- Patient has measurable disease in which to capture response, defined as one or more of the following:
- Serum M-protein level > 1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis; or
- Urinary M-protein excretion > 1000 mg/24 hours; or
- Bone marrow plasmacytosis of > 30% by bone marrow aspirate and/or biopsy; or
- Serum free light chains (by the Freelite test) > 2 X the upper limit of normal, in the absence of renal failure.
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- Evidence of active disease by radiographic techniques
- Performance status (PS) of <= 2 as per Southwest Oncology Group scale, unless PS of 3-4 based solely on bone pain.
- Patients must have a platelet count >= 50,000/mm3, and an absolute neutrophil count of at least 1,000/μl.
- Patients must have adequate renal function defined as creatinine clearance > 30ml/min.
- 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 test 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 Institutional Review Board 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 4 weeks.
- Has received previous bortezomib therapy
- Significant neurotoxicity, defined as grade > 2 neurotoxicity per National Cancer Institute Common Toxicity Criteria.
- Platelet count < 50,000/mm3, or ANC < 1,000/μl
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome.
- Patient has hypersensitivity to bortezomib, boron, or mannitol
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- 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 Class III or Class IV heart failure.
- Myocardial infarction within the last 6 months.
- Non-secretory multiple myeloma, unless the patient has measurable lesions on computed tomography, magnetic resonance imaging and/or positron emission tomography.
- Uncontrolled, active infection.
- 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 [beta-HCG] test at screening, and will be required to use a medically approved contraceptive method. Pregnancy testing will be performed prior to administration of each cycle 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 II Dose-Response Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory Multiple Myeloma
Velcade (bortezomib, PS-341) has recently been approved by the Food and Drug Administration (FDA) for the treatment of multiple myeloma for patients who have received at least one prior therapy. Velcade is a unique compound developed by scientists at Millennium Pharmaceuticals, Inc. Velcade enters cells and affects the way they divide. Cancer cells are particularly sensitive. Velcade interferes with the enzyme "proteasome" which is responsible for allowing cells to divide. When cancer cells cannot divide, they die. Velcade falls into the class of drugs known as "proteasome inhibitors."
Read the detailed description
Studies at the Myeloma Institute for Research \& Therapy have shown that Velcade is very effective in treating patients who are relapsing after having been treated with at least two lines of prior therapy.
One key factor in multiple myeloma is bone destruction caused by the myeloma cells. Most patients with multiple myeloma (80%) will develop skeletal lesions, despite treatment. These lesions are rarely repaired, even when the myeloma is in remission.
Experience at MIRT has suggested that Velcade may increase osteoblast (bone cells that cause bone growth) activity. One goal of this study is to identify if Velcade's effect on myeloma is due to its ability to increase osteoblasts.
This study also has the following goals:
- To find out the lowest dose of Velcade that has an effect on myeloma and also increases bone activation;
- To identify ways to predict if Velcade will increase bone activation.
Time periods are:
According to cohort assignment, you will receive three cycles of Velcade®™ (1.3 mg/m2, 1.0 mg/m2 or 0.7 mg/m2) on days 1, 4, 8, and 11, on a 21-day cycle.
During the first two cycles of Velcade®™, bone markers (tests on your bones) will be measured Days 1, 4, 8, 11: Pre-dose, post-dose, and every 2 to 4 hours for 8 hours.
Days 2-3, 5-7, 9-10, 12-21: every 24 hours, beginning with the immediate post-dose sample (+/- 2 hours)
During the third cycle of Velcade®™, bone markers will be measured Days 1 and 11: Pre-dose and post-dose, and then again on Day 21.
- Conditions
- Multiple Myeloma
- Being tested
- VELCADE™
- Keywords
- Multiple Myeloma
- 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™Drug
Also called Bortezomib
Patients will receive two cycles of VELCADE™ (1.3 mg/m2, 1.0 mg/m2 or 0.7 mg/m2) on days 1, 4, 8, and 11, on a 21 day cycle. No growth factors or bisphosphonates will be allowed during study treatment. Bone markers will be measured:
Days 1, 4, 8, 11: Pre-dose, post-dose, and every 2-4 hours for 8 hours Days 2-3, 5-7, 9-10, 12-21: every 24 hours, beginning with the immediate post-dose sample (+/- 2 hours) Other laboratory and radiologic studies will be performed as detailed in the Study Calendar.
Patients will complete the study after two cycles of VELCADE™. However, if a patient continues to receive VELCADE™ as part of his/her treatment for relapsing MM, routine bone markers may be monitored for the duration of VELCADE™ treatment as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Velcade, Cohort A | Experimental | Treatment: 1.3 mg/m^2 Receives: Drug: VELCADE™ |
| Velcade, Cohort B | Experimental | Treatment: 1.0 mg/m^2 Receives: Drug: VELCADE™ |
| Velcade, Cohort C | Experimental | Treatment: 0.7 mg/m^2 Receives: Drug: VELCADE™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Positive Response to Bortezomib Measured by the Bone Marker Parathyroid Hormone
Parathyroid hormone: Any increase in PTH was considered response
Measured: 6 months
Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Calcium
Calcium: any Calcium increase would refer to a positive response.
Measured: 6 months
Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Alkaline Phosphatase
Alkaline phosphatase: If the Alkaline phosphatase increases it's considered positive response
Measured: 6 months
Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Magnesium
Magnesium: Any Magnesium increase would refer to a positive response.
Measured: 6 months
Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Phosphate.
Phosphate: any Phosphate increase would refer to a positive response.
Measured: 6 months
Secondary outcomes (1)
Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Osteocalcin
Osteocalcin: Any Osteocalcin increase means positive response.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startApr 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Why it stopped: study terminated due to 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurizio Zangari, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128921
- Sponsor's protocol ID
- UARK 2004-22
- Status last verified
- Apr 2012
- First submitted
- 8 Aug 2005
- Last updated
- 26 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Dose-Response Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00128921
- Acronym / sponsor ID
- UARK 2004-22
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study terminated due to low accrual
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 10 Aug 2005 (estimated)
- Results
- Posted 26 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Velcade (bortezomib, PS-341) has recently been approved by the Food and Drug Administration (FDA) for the treatment of multiple myeloma for patients who have received at least one prior therapy. Velcade is a unique compound developed by scientists at Millennium Pharmaceuticals, Inc. Velcade enters cells and affects the way they divide. Cancer cells are particularly sensitive. Velcade interferes with the enzyme "proteasome" which is responsible for allowing cells to divide. When cancer cells cannot divide, they die. Velcade falls into the class of drugs known as "proteasome inhibitors."
Detailed description
Studies at the Myeloma Institute for Research \& Therapy have shown that Velcade is very effective in treating patients who are relapsing after having been treated with at least two lines of prior therapy.
One key factor in multiple myeloma is bone destruction caused by the myeloma cells. Most patients with multiple myeloma (80%) will develop skeletal lesions, despite treatment. These lesions are rarely repaired, even when the myeloma is in remission.
Experience at MIRT has suggested that Velcade may increase osteoblast (bone cells that cause bone growth) activity. One goal of this study is to identify if Velcade's effect on myeloma is due to its ability to increase osteoblasts.
This study also has the following goals:
- To find out the lowest dose of Velcade that has an effect on myeloma and also increases bone activation;
- To identify ways to predict if Velcade will increase bone activation.
Time periods are:
According to cohort assignment, you will receive three cycles of Velcade®™ (1.3 mg/m2, 1.0 mg/m2 or 0.7 mg/m2) on days 1, 4, 8, and 11, on a 21-day cycle.
During the first two cycles of Velcade®™, bone markers (tests on your bones) will be measured Days 1, 4, 8, 11: Pre-dose, post-dose, and every 2 to 4 hours for 8 hours.
Days 2-3, 5-7, 9-10, 12-21: every 24 hours, beginning with the immediate post-dose sample (+/- 2 hours)
During the third cycle of Velcade®™, bone markers will be measured Days 1 and 11: Pre-dose and post-dose, and then again on Day 21.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Velcade, Cohort A | Experimental | Drug: VELCADE™Treatment: 1.3 mg/m^2 |
| Velcade, Cohort B | Experimental | Drug: VELCADE™Treatment: 1.0 mg/m^2 |
| Velcade, Cohort C | Experimental | Drug: VELCADE™Treatment: 0.7 mg/m^2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- History of histologically documented MM with relapsed or progressive disease after at least one line of prior therapy.
- Patient has measurable disease in which to capture response, defined as one or more of the following:
- Performance status (PS) of <= 2 as per Southwest Oncology Group scale, unless PS of 3-4 based solely on bone pain.
- Patients must have a platelet count >= 50,000/mm3, and an absolute neutrophil count of at least 1,000/μl.
- Patients must have adequate renal function defined as creatinine clearance > 30ml/min.
Key exclusion criteria (15 listed)
- Chemotherapy or radiotherapy received within the previous 4 weeks.
- Has received previous bortezomib therapy
- Significant neurotoxicity, defined as grade > 2 neurotoxicity per National Cancer Institute Common Toxicity Criteria.
- Platelet count < 50,000/mm3, or ANC < 1,000/μl
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes 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 |
|---|---|---|
| VELCADE™Also: BortezomibPatients will receive two cycles of VELCADE™ (1.3 mg/m2, 1.0 mg/m2 or 0.7 mg/m2) on days 1, 4, 8, and 11, on a 21 day cycle. No growth factors or bisphosphonates will be allowed during study treatment. Bone markers will be measured: Days 1, 4, 8, 11: Pre-dose, post-dose, and every 2-4 hours for 8 hours Days 2-3, 5-7, 9-10, 12-21: every 24 hours, beginning with the immediate post-dose sample (+/- 2 hours) Other laboratory and radiologic studies will be performed as detailed in the Study Calendar. Patients will complete the study after two cycles of VELCADE™. However, if a patient continues to receive VELCADE™ as part of his/her treatment for relapsing MM, routine bone markers may be monitored for the duration of VELCADE™ treatment as clinically indicated. | Drug | Velcade, Cohort A, Velcade, Cohort B, Velcade, Cohort C |
Primary outcome
Number of Participants With a Positive Response to Bortezomib Measured by the Bone Marker Parathyroid Hormone
Time frame: 6 months
Parathyroid hormone: Any increase in PTH was considered response
Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Calcium
Time frame: 6 months
Calcium: any Calcium increase would refer to a positive response.
Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Alkaline Phosphatase
Time frame: 6 months
Alkaline phosphatase: If the Alkaline phosphatase increases it's considered positive response
Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Magnesium
Time frame: 6 months
Magnesium: Any Magnesium increase would refer to a positive response.
Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Phosphate.
Time frame: 6 months
Phosphate: any Phosphate increase would refer to a positive response.
1 secondary outcome
Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Osteocalcin
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about A Phase II Dose-Response Study of Velcade®Link 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
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 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 14 inclusion and 15 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 26 Apr 2012. 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?
Yes. Results are posted in the registry (first posted 26 Apr 2012). 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?
Number of Participants With a Positive Response to Bortezomib Measured by the Bone Marker Parathyroid Hormone (time frame: 6 months). The study lists 5 primary outcomes in all. 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 26 Apr 2012.