Multiple MyelomaPhase 2NCT00241371
A Phase II Study of Clofarabine in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing Clofarabine in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To determine the overall response rate (CR+PR) of patients with relapsed or refractory multiple myeloma treated with clofarabine. 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?
- Clofarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Dec 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
- Multiple myeloma diagnosed by standard criteria.
- Measurable levels of monoclonal protein in serum (>= 0.5 g/dL) or urine (>= 0.2 g/24 hr).
- At least 1 prior therapies for multiple myeloma with documented evidence of progression on the most recent treatment.
- Age 18 years or older.
- ECOG performance status <= 2.
- Acceptable organ and marrow function as defined below:
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- Hemoglobin >= 8 gm/dL
- Absolute neutrophil count >= 1,000/mm3
- Platelets >= 50,000/mm3
- Total bilirubin <= 2.5 X institutional upper limit of normal
- AST, ALT <= 2.5 X institutional upper limit of normal
- Creatinine 1.5 x institutional upper limit of normal
- Normal cardiac function as determined by standard institutional methods
- Women of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Receiving any other investigational agents.
- Receiving concurrent steroids with a dose equivalent of prednisone of >= 150 mg/month.
- Pregnant or nursing.
- Active systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- Severe concurrent disease, including severe insulin-dependent diabetes, uncontrolled hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery disease, or symptomatic CNS involvement or psychiatric illness/social situations that would limit compliance with study requirements.
- History of other malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast unless the subject has been off treatment and free from disease for >= 3 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
To determine the overall response rate (CR+PR) of patients with relapsed or refractory multiple myeloma treated with clofarabine.
Read the detailed description
To determine the time to response, duration of response, and time to progression of patients treated with clofarabine.
To determine the safety and tolerability of clofarabine in these patients.
- Conditions
- Multiple Myeloma
- Being tested
- Clofarabine
- 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.
ClofarabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Clofarabine | Experimental | 4 mg/m2 IV over 1 hour on days 1-5 of each 28 day cycle. Receives: Drug: Clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (CR+PR)
Measured: Every 3 months
Secondary outcomes (4)
Time to response
Measured: Every 3 months
Safety and tolerability of clofarabine
Measured: 30 days after last treatment
Duration of response
Measured: Every 3 months
Time to progression
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startMar 2005
- Primary completionNov 2005
- Study completionDec 2007
Why it stopped: No response seen in patients
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.
- More trials run by Washington University School of MedicineThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Vij, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241371
- Sponsor's protocol ID
- 04-0916
- Status last verified
- Aug 2013
- First submitted
- 17 Oct 2005
- Last updated
- 13 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Clofarabine in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00241371
- Acronym / sponsor ID
- 04-0916
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No response seen in patients
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Oct 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.
To determine the overall response rate (CR+PR) of patients with relapsed or refractory multiple myeloma treated with clofarabine.
Detailed description
To determine the time to response, duration of response, and time to progression of patients treated with clofarabine.
To determine the safety and tolerability of clofarabine in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clofarabine | Experimental | Drug: Clofarabine4 mg/m2 IV over 1 hour on days 1-5 of each 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Multiple myeloma diagnosed by standard criteria.
- Measurable levels of monoclonal protein in serum (>= 0.5 g/dL) or urine (>= 0.2 g/24 hr).
- At least 1 prior therapies for multiple myeloma with documented evidence of progression on the most recent treatment.
- Age 18 years or older.
- ECOG performance status <= 2.
Key exclusion criteria (6 listed)
- Receiving any other investigational agents.
- Receiving concurrent steroids with a dose equivalent of prednisone of >= 150 mg/month.
- Pregnant or nursing.
- Active systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- Severe concurrent disease, including severe insulin-dependent diabetes, uncontrolled hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery disease, or symptomatic CNS involvement or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Clofarabine | Drug | Clofarabine |
Primary outcome
Overall response rate (CR+PR)
Time frame: Every 3 months
4 secondary outcomes
Time to response
Time frame: Every 3 months
Safety and tolerability of clofarabine
Time frame: 30 days after last treatment
Duration of response
Time frame: Every 3 months
Time to progression
Time frame: Every 3 months
Results and safety
The study was stopped early (reason given: No response seen in patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Ravi Vij, M.D. principal investigator
Washington University School of Medicine
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 Clofarabine in people with Multiple Myeloma, run by Washington University School of Medicine 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 15 inclusion and 6 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 13 Aug 2013. 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?
The study was stopped early (reason given: No response seen in patients). 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?
Overall response rate (CR+PR) (time frame: Every 3 months). 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 13 Aug 2013.