Multiple MyelomaPhase 2NCT00131261
Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma
A Phase 2 study testing PXD101 and Dexamethasone in people with Multiple Myeloma, run by Valerio Therapeutics at 10 sites in 4 countries.
Trial summary
The purpose of this open-label, non-randomized trial is to assess the safety and effectiveness of PXD101, both alone and in combination with dexamethasone, in patients with advanced multiple myeloma. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. 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 and Dexamethasone
- How many people
- 25 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Jan 2005to 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
- Signed informed consent
- A confirmed diagnosis of multiple myeloma, diagnostic criteria as follows, in patients who have failed at least two prior lines of therapy.
- Diagnostic criteria for multiple myeloma:
- A Monoclonal immunoglobulin (M-component) in serum of IgG-type > 30 g/l, of IgA type > 20 g/l, of IgD type or IgE type of any concentration and/or excretion of M-component in the urine of type k or l type > 1 g/24 hours.
- B M-component in serum and/or urine in lower concentration than indicated above in 'A'.
- C 10% or more plasma cells in bone marrow aspirate or plasmocytosis in biopsy from bone marrow or soft tissue tumor D Osteolytical bone lesions.
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- The diagnosis of multiple myeloma demands one of the following combinations: A+C, A+D, or B+C+D.
- Evaluable disease (as defined above)
- Adequate bone marrow and hepatic functions including the following:
- WBC > 2.5 x 109/l, absolute neutrophil count ≥ 1.5 x 109/l, platelets ≥ 50x109/l
- Total bilirubin ≤1.5 x upper normal limit.
- AST (SGOT), ALT (SGPT) ≤2.5 x upper normal limit
- Serum potassium within normal range.
- Age ≥18 years
- Performance status (PS) ≤2 (ECOG scale)
- Estimated life expectancy greater than 3 months
- Female patients with reproductive potential with a negative serum pregnancy test within the last 7 days before trial enrollment and use a safe contraceptive during and in a period of 60 days after the trial. Fertile female partners to male participants must likewise use contraceptive.
Who cannot join
- Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea). Exception: bisphosphonates for bone disease caused by multiple myeloma.
- Active infection or any medical condition likely to interfere with trial procedures.
- Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
- A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >500; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix B for list).
- Patients with renal insufficiency defined as a calculated creatinine clearance of < 45 ml/min.
- Clinically significant central nervous system disorders requiring neuroleptics or anti-convulsant medication.
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- Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- Other malignant diseases requiring treatment
- Non-secretory multiple myeloma or symptomatic amyloidosis
- Pregnant or breast-feeding women
- Women of childbearing age and potential, who do not use effective contraception
- Known HIV positivity
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States4 sites
Northwestern University
Chicago, Illinois, 60611
Research Facility
New York, New York, 10021
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
James Berenson, MD, Inc
West Hollywood, California, 90069
Norway3 sites
Research Facility
Bergen, N-5021
Research Facility
Oslo, N-0407
Research Facility
Trondheim, N-7006
United Kingdom2 sites
Christie Hospital NHS Trust
Manchester, M20 4BX
The Royal Marsden NHS Trust
Surrey, SM2 5NG
About this study
Official title: A Phase II Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma
The purpose of this open-label, non-randomized trial is to assess the safety and effectiveness of PXD101, both alone and in combination with dexamethasone, in patients with advanced multiple myeloma. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Various members of this class of drugs have shown activity in preclinical studies and in initial clinical trials of multiple myeloma and lymphoma. Furthermore, HDAC inhibitors, including PXD101, have been shown to sensitize myeloma cells to the killing effect of other chemotherapeutic agents, including dexamethasone, a well-established agent in relapsing myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- PXD101, Dexamethasone
- Keywords
- Multiple Myeloma, Neoplasms
- Medical subject headings
- Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXD101Drug
DexamethasoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2007
- Study completionJun 2007
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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valerio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- enquiries@topotarget.com, Study chair, Valerio Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131261
- Sponsor's protocol ID
- PXD101-301-G
- Status last verified
- Jul 2015
- First submitted
- 17 Aug 2005
- 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 Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00131261
- Acronym / sponsor ID
- PXD101-301-G
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Valerio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 18 Aug 2005 (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.
The purpose of this open-label, non-randomized trial is to assess the safety and effectiveness of PXD101, both alone and in combination with dexamethasone, in patients with advanced multiple myeloma. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Various members of this class of drugs have shown activity in preclinical studies and in initial clinical trials of multiple myeloma and lymphoma. Furthermore, HDAC inhibitors, including PXD101, have been shown to sensitize myeloma cells to the killing effect of other chemotherapeutic agents, including dexamethasone, a well-established agent in relapsing myeloma.
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 (17 listed)
- Signed informed consent
- A confirmed diagnosis of multiple myeloma, diagnostic criteria as follows, in patients who have failed at least two prior lines of therapy.
- A Monoclonal immunoglobulin (M-component) in serum of IgG-type > 30 g/l, of IgA type > 20 g/l, of IgD type or IgE type of any concentration and/or excretion of M-component in the urine of type k or l type > 1 g/24 hours.
- B M-component in serum and/or urine in lower concentration than indicated above in 'A'.
- C 10% or more plasma cells in bone marrow aspirate or plasmocytosis in biopsy from bone marrow or soft tissue tumor D Osteolytical bone lesions.
Key exclusion criteria (12 listed)
- Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea). Exception: bisphosphonates for bone disease caused by multiple myeloma.
- Active infection or any medical condition likely to interfere with trial procedures.
- Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
- A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >500; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix B for list).
- Patients with renal insufficiency defined as a calculated creatinine clearance of < 45 ml/min.
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 | – |
| Dexamethasone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
enquiries@topotarget.com study chair
Valerio Therapeutics
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PXD101 and Dexamethasone in people with Multiple Myeloma, run by Valerio Therapeutics at 10 sites in 4 countries.
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 17 inclusion and 12 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 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 10 sites in United States, Norway, United Kingdom, Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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.