Multiple MyelomaPhase 1/2NCT00327249
Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients
A Phase 1/2 study testing imexon in people with Multiple Myeloma, run by AmpliMed Corporation at 2 sites in United States.
Trial summary
AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. 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?
- imexon
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Jan 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
- Advanced myeloma, with measurable disease as defined in the protocol.
- Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products.
- Able to perform the activities of daily living.
- Off prior therapy for at least 2-4 weeks depending on the drug.
- Blood counts and blood chemistries in or near normal range.
- If female, neither pregnant nor nursing.
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- Willing to use contraceptives to prevent pregnancy.
- No other serious illnesses.
- No other active malignancy.
- No serious infections.
- No current other drug therapy for the myeloma except for steroid therapy under certain circumstances. Biphosphonate therapy is permitted.
- Prior radiation is permitted.
Who cannot join
- Use of corticosteroids for amyloid disorders, or high dose chronic steroids.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Investigational Site 008
Houston, Texas, 77030
Investigational Site 025
Little Rock, Arkansas, 72206
About this study
Official title: A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma
AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma
- Conditions
- Multiple Myeloma
- Being tested
- imexon
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imexonDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximally tolerated dose of imexon in multiple myeloma patients
evaluate the toxicity of imexon
Preliminarily evaluate efficacy in terms of response and progression free survival.
Secondary outcomes (1)
Evaluate biomarker responses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startOct 2005
- Primary completionJul 2006
- Study completionJan 2008
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)
Sponsor and investigators
- Lead sponsor
- AmpliMed Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327249
- Sponsor's protocol ID
- AMP-007
- Status last verified
- Aug 2009
- First submitted
- 17 May 2006
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00327249
- Acronym / sponsor ID
- AMP-007
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AmpliMed CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 18 May 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.
AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple 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 (12 listed)
- Advanced myeloma, with measurable disease as defined in the protocol.
- Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products.
- Able to perform the activities of daily living.
- Off prior therapy for at least 2-4 weeks depending on the drug.
- Blood counts and blood chemistries in or near normal range.
Key exclusion criteria (1 listed)
- Use of corticosteroids for amyloid disorders, or high dose chronic steroids.
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 |
|---|---|---|
| imexon | Drug | – |
Primary outcome
Determine the maximally tolerated dose of imexon in multiple myeloma patients
evaluate the toxicity of imexon
Preliminarily evaluate efficacy in terms of response and progression free survival.
1 secondary outcome
Evaluate biomarker responses.
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 11 Aug 2009.
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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.
2 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 imexon in people with Multiple Myeloma, run by AmpliMed Corporation at 2 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 12 inclusion and 1 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 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
What does the primary outcome measure?
Determine the maximally tolerated dose of imexon in multiple myeloma patients. The study lists 3 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 11 Aug 2009.