Multiple MyelomaPhase 2NCT00431340
A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
A Phase 2 study testing PXD101 in people with Multiple Myeloma, run by Valerio Therapeutics at 3 sites in United States.
Trial summary
This open-label study will assess anti-tumor activity and safety of belinostat in combination with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and bortezomib on the same days: i.e. 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?
- PXD101
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2007to Jun 2007
- 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
- Diagnosis of multiple myeloma.
- Status of refractory to or relapsed from at least one prior bortezomib-containing regimen.
- Progressive disease.
- Age >= 18 years.
- Karnofsky performance status >= 60%
- Acceptable liver function:
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- Bilirubin =< 1.5 x ULN (upper limit of normal)
- Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN
- Acceptable hematologic status:
- Absolute Neutrophil Count (ANC) >= 1.5 x 109/L
- Platelet count >= 100 x 109/L
- Hemoglobin >= 9 g/dL
- Coagulation status PT-INR/PTT =< 1.5 x ULN or in the therapeutic range if on anticoagulation therapy. (PT-INR/PTT= prothrombin - international normalized ratio / prothrombin time)
- Serum potassium within normal range.
- Estimated life expectancy greater than 3 months.
- Signed, written IRB (institutional Review Board)-approved informed consent.
Who cannot join
- Non-secretory multiple myeloma or symptomatic amyloidosis.
- Hypersensitivity to bortezomib, boron, or mannitol.
- Less than 4 weeks since prior chemotherapy, radiotherapy, endocrine therapy, or immunotherapy, except if disease is rapidly progressing.
- Less than 4 weeks since prior use of other investigational agents.
- Serious concomitant systemic disorders (e.g. active infection).
- Significant cardiovascular disease.
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- Marked baseline prolongation of QT/QTc (corrected QT interval)interval.
- Central nervous system disorders requiring neuroleptics / anti-convulsants.
- Peripheral sensory neuropathy of ≥ Grade 2
- Renal insufficiency defined as a creatinine clearance of < 30 ml/min.
- Non-willingness to use effective contraceptive methods for patients of child-bearing age / potential.
- Pregnant or breast-feeding women.
- Known HIV positivity.
- Prior treatment with belinostat (PXD101), or any other HDAC (histone deacetylase) inhibitor.
- Altered mental status which precludes an understanding of the Informed Consent Document.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Center for cancer and blood disorders
Bethesda, Maryland, 20817
Baylor University Medical Center
Dallas, Texas, 75246
Oncotherapeutics
West Hollywood, California, 90069
About this study
This open-label study will assess anti-tumor activity and safety of belinostat in combination with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.
- Conditions
- Multiple Myeloma
- Being tested
- PXD101
- Keywords
- Multiple myeloma, myeloma, plasma cell myeloma, bone marrow cancer, myelomatosis, Kahler's disease, PXD101, belinostat, bortezomib
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Bone Marrow Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXD101Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate of belinostat administered in combination with bortezomib in multiple myeloma subjects who are refractory to or have relapsed from at least one prior bortezomib-containing regimen.
Safety of belinostat plus bortezomib.
Secondary outcomes (2)
Duration of response, time to response (TTR), and time to progression (TTP).
Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Terminated due to dose limiting toxicity
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.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valerio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431340
- Sponsor's protocol ID
- PXD101-CLN-16
- Status last verified
- Jul 2015
- First submitted
- 2 Feb 2007
- Last updated
- 8 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00431340
- Acronym / sponsor ID
- PXD101-CLN-16
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, myeloma, plasma cell myeloma, bone marrow cancer, myelomatosis, Kahler's disease, PXD101, belinostat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to dose limiting toxicity
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Valerio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 5 Feb 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.
This open-label study will assess anti-tumor activity and safety of belinostat in combination with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of multiple myeloma.
- Status of refractory to or relapsed from at least one prior bortezomib-containing regimen.
- Progressive disease.
- Age >= 18 years.
- Karnofsky performance status >= 60%
Key exclusion criteria (15 listed)
- Non-secretory multiple myeloma or symptomatic amyloidosis.
- Hypersensitivity to bortezomib, boron, or mannitol.
- Less than 4 weeks since prior chemotherapy, radiotherapy, endocrine therapy, or immunotherapy, except if disease is rapidly progressing.
- Less than 4 weeks since prior use of other investigational agents.
- Serious concomitant systemic disorders (e.g. active infection).
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 |
|---|---|---|
| PXD101 | Drug | – |
Primary outcome
Objective response rate of belinostat administered in combination with bortezomib in multiple myeloma subjects who are refractory to or have relapsed from at least one prior bortezomib-containing regimen.
Safety of belinostat plus bortezomib.
2 secondary outcomes
Duration of response, time to response (TTR), and time to progression (TTP).
Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.
Results and safety
The study was stopped early (reason given: Terminated due to dose limiting toxicity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PXD101 in people with Multiple Myeloma, run by Valerio Therapeutics at 3 sites 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 16 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 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 stopped early (reason given: Terminated due to dose limiting toxicity). Results are not available in the source record.
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?
Objective response rate of belinostat administered in combination with bortezomib in multiple myeloma subjects who are refractory to or have relapsed from at least one prior bortezomib-containing regimen.. The study lists 2 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 8 Jul 2015.