Multiple MyelomaPhase 1/2NCT00352742
A Study of ATN-224 and Bortezomib in Patients With Multiple Myeloma
A Phase 1/2 study testing ATN-224 + bortezomib in people with Multiple Myeloma, run by Attenuon at 10 sites in United States.
Trial summary
The purpose of this study is to describe the safety and effect of ATN-224 in combination with bortezomib (Velcade®) in patients with Multiple Myeloma who are relapsed from or refractory to bortezomib. 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?
- ATN-224 + bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2006to Dec 2008
- Phase
- Phase 1/2
- 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
- Histologically or cytologically confirmed multiple myeloma that has been treated with at least one different prior anti-myeloma regimens including one with bortezomib and is currently showing evidence of progressive disease
- Myeloma that is refractory to the most recent bortezomib-containing regimen as demonstrated by progressive disease while on bortezomib or that relapsed within 12 weeks of the last dose of bortezomib either as a single agent or in combination with other agents
- Measurable disease defined as a serum M-protein concentration on electrophoresis ≥1 g/dL of IgG myeloma or ≥0.5 g/dL of IgA myeloma or IgM myeloma or urinary excretion of monoclonal light chain ≥200 mg/24 hours
- Age >18 years
- Life expectancy of greater than 3 months
- ECOG performance status <2 (Karnofsky >60%; see Appendix A)
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- Adequate organ and marrow function as defined below:
- absolute neutrophil count ≥1,000/uL
- platelets ≥75,000/uL
- hemoglobin ≥8 g/dL
- total bilirubin ≤2 X institutional upper limit of normal (ULN)
- AST(SGOT) and ALT(SGPT) ≤3 X ULN
- creatinine clearance ≥30 mL/min (measured or calculated)
- Patients are allowed to receive blood transfusions before receiving their first dose of ATN-224 to bring the hemoglobin level to ≥8 g/dL to meet eligibility criteria.
- Use of adequate contraception. The effects of ATN 224 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because antiangiogenic agents are known to be teratogenic, women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal and/or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation through the follow up visit 28 days after the last dose of ATN 224.
- Willingness to forego taking copper- or zinc-containing vitamins or supplements
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or thalidomide, lenalidomide, dexamethasone, arsenic trioxide, bortezomib, or glucocorticosteroids within 3 weeks prior to the first dose of ATN-224 or failure to recover from reversible adverse events due to agents administered previously
- Patients who cannot tolerate, based on previous experience, the assigned dose of bortezomib, including those with ≥ Grade 2 neuropathy
- Concurrent administration of any other investigational agents
- History of malabsorption syndromes or other gastrointestinal disorders that may affect ATN-224 absorption, including bowel obstruction, celiac disease, sprue, cystic fibrosis
- Ineligible to receive omeprazole (Prilosec® OTC) or other long-acting antacid
- Inability to swallow study medication capsules
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- Not a suitable candidate in the opinion of the investigator for additional bortezomib therapy
- Other serious medical or psychiatric illness preventing informed consent or intensive treatment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Women who are pregnant or lactating
- Known history of HIV
- History of another prior cancer, except basal cell carcinoma or carcinoma in situ of the cervix (or if there has been no evidence of recurrence for at least 5 years)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Billings Clinic
Billings, Montana, 59101
SUNY Downstate
Brooklyn, New York, 11203
Roswell Park Cancer Institute
Buffalo, New York, 14263
Mary Crowley Medical Research Center
Dallas, Texas, 75246
Florida Cancer Specialists
Fort Myers, Florida, 33901
Hematolgy-Oncology Medical Group of Fresno, Inc.
Fresno, California, 93720
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Tyler Cancer Center
Tyler, Texas, 75702
Institute for Myeloma and Bone Cancer Research
West Hollywood, California, 90069
About this study
Official title: A Phase I/II Study of ATN-224 and Bortezomib in Patients With Multiple Myeloma Relapsed From or Refractory to Bortezomib
The purpose of this study is to describe the safety and effect of ATN-224 in combination with bortezomib (Velcade®) in patients with Multiple Myeloma who are relapsed from or refractory to bortezomib.
Read the detailed description
Multiple myeloma is a bone marrow based malignancy of plasma cells that is highly treatable but rarely curable. Angiogenesis, defined as the growth of new blood vessels from pre-existing vessels, is a requirement for the growth of nearly all tumors. An increase in bone marrow angiogenesis is present in Multiple Myeloma and correlates with disease progression. Several new therapies that target angiogenic pathways have shown clinical efficacy. ATN-224 is a small molecule that has been shown in pre-clinical studies to be antiangiogenic.
Using one agent to overcome resistance of another agent is a treatment regimen used in oncology. A preclinical study with the combination of ATN-224 and bortezomib shows that the combination is more effective than either single agent in a bortezomib resistant cell line.
- Conditions
- Multiple Myeloma
- Being tested
- ATN-224 + bortezomib
- Keywords
- Multiple myeloma, bortezomib, ATN-224, refractory, relapsed, antiangiogenic
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATN-224 + bortezomibDrug
ATN-224 and bortezomib dose to be determined in Phase I portion of study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ATN-224 + bortezomib Receives: Drug: ATN-224 + bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determine a safe dose of ATN-224 and bortezomib to be used in the phase II portion of the study
Measured: Ongoing
Phase II: Efficacy
Measured: End of Study
Secondary outcomes (2)
Phase I: Preliminary evidence of efficacy
Measured: End of Study
Phase II: progression-free survival and duration of response
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2008 (estimated)
- Study completionDec 2008 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attenuon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gilad Gordon, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352742
- Sponsor's protocol ID
- ATN-224-007
- Status last verified
- Oct 2008
- First submitted
- 13 Jul 2006
- Last updated
- 28 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of ATN-224 and Bortezomib in Patients With Multiple Myeloma Relapsed From or Refractory to Bortezomib
- ClinicalTrials.gov ID
- NCT00352742
- Acronym / sponsor ID
- ATN-224-007
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, bortezomib, ATN-224, refractory, relapsed, antiangiogenic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- AttenuonIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 17 Jul 2006 (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 study is to describe the safety and effect of ATN-224 in combination with bortezomib (Velcade®) in patients with Multiple Myeloma who are relapsed from or refractory to bortezomib.
Detailed description
Multiple myeloma is a bone marrow based malignancy of plasma cells that is highly treatable but rarely curable. Angiogenesis, defined as the growth of new blood vessels from pre-existing vessels, is a requirement for the growth of nearly all tumors. An increase in bone marrow angiogenesis is present in Multiple Myeloma and correlates with disease progression. Several new therapies that target angiogenic pathways have shown clinical efficacy. ATN-224 is a small molecule that has been shown in pre-clinical studies to be antiangiogenic.
Using one agent to overcome resistance of another agent is a treatment regimen used in oncology. A preclinical study with the combination of ATN-224 and bortezomib shows that the combination is more effective than either single agent in a bortezomib resistant cell line.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ATN-224 + bortezomibATN-224 + bortezomib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed multiple myeloma that has been treated with at least one different prior anti-myeloma regimens including one with bortezomib and is currently showing evidence of progressive disease
- Myeloma that is refractory to the most recent bortezomib-containing regimen as demonstrated by progressive disease while on bortezomib or that relapsed within 12 weeks of the last dose of bortezomib either as a single agent or in combination with other agents
- Measurable disease defined as a serum M-protein concentration on electrophoresis ≥1 g/dL of IgG myeloma or ≥0.5 g/dL of IgA myeloma or IgM myeloma or urinary excretion of monoclonal light chain ≥200 mg/24 hours
- Age >18 years
- Life expectancy of greater than 3 months
Key exclusion criteria (12 listed)
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or thalidomide, lenalidomide, dexamethasone, arsenic trioxide, bortezomib, or glucocorticosteroids within 3 weeks prior to the first dose of ATN-224 or failure to recover from reversible adverse events due to agents administered previously
- Patients who cannot tolerate, based on previous experience, the assigned dose of bortezomib, including those with ≥ Grade 2 neuropathy
- Concurrent administration of any other investigational agents
- History of malabsorption syndromes or other gastrointestinal disorders that may affect ATN-224 absorption, including bowel obstruction, celiac disease, sprue, cystic fibrosis
- Ineligible to receive omeprazole (Prilosec® OTC) or other long-acting antacid
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 |
|---|---|---|
| ATN-224 + bortezomibATN-224 and bortezomib dose to be determined in Phase I portion of study | Drug | 1 |
Primary outcome
Phase I: Determine a safe dose of ATN-224 and bortezomib to be used in the phase II portion of the study
Time frame: Ongoing
Phase II: Efficacy
Time frame: End of Study
2 secondary outcomes
Phase I: Preliminary evidence of efficacy
Time frame: End of Study
Phase II: progression-free survival and duration of response
Time frame: End of Study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2008.
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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.
Gilad Gordon, MD study director
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATN-224 + bortezomib in people with Multiple Myeloma, run by Attenuon at 10 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 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: stopped early, as of the sponsor's last update on 28 Oct 2008. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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. 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?
Phase I: Determine a safe dose of ATN-224 and bortezomib to be used in the phase II portion of the study (time frame: Ongoing). 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 28 Oct 2008.