Relapsed and Refractory Multiple MyelomaPhase 2NCT00664378
Efficacy Study of CYT997 in Multiple Myeloma
A Phase 2 study testing CYT997 in people with Relapsed and Refractory Multiple Myeloma, run by Gilead Sciences at 1 site in Australia.
Trial summary
This is a clinical research study that is designed to test the safety of CYT997 when given to patients with multiple myeloma and to test if CYT997 has any activity against that cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed and Refractory Multiple Myeloma
- What is being tested?
- CYT997
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2008to Feb 2011
- 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 per International Working Group (IWG) criteria
- Have received at least 1 but no more than 4 prior lines of therapy
- Have failed to respond to the most recently administered anti-myeloma therapy
- Have a life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status < 3
- At registration absolute neutrophil count > 1x10^9/L and platelet count > 50 x 10^9/L unsupported
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- At registration bilirubin less than 1.5 x upper limit of normal and transaminases less than 2 x upper limit of normal and serum creatinine less than 0.19 mmol/L
- Written informed consent
- Must agree to adequate contraceptive measure if indicated
Who cannot join
- Patients with monoclonal gammopathy of undetermined significance
- Known or suspected hypersensitivity to CYT997
- Patient with uncontrolled intercurrent illness
- Active infections or other illnesses that precludes chemotherapy administration or patient compliance.
- Pregnant or lactating women.
- Patients who have received any other investigational agents in the last 3 weeks prior to the start of treatment.
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- Patients with the following conditions will be excluded:
- myocardial infarction or stroke within 6 months
- unstable angina pectoris or acute ischemic changes on ECG
- history of diabetic retinopathy
- symptomatic peripheral arterial disease
- major surgery in the last 30 days
- Patients with uncontrolled diarrhea despite optimal medication and those with any history of acute gastrointestinal bleeding
- Patients with a baseline prolongation of the QTc interval of Common Terminology Criteria (CTC) Grade 1 (QTc > 0.45-0.47 sec) or greater
- Patients with impaired cardiac function or clinically significant cardiac diseases, including any one of the following:
- left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram;
- complete left bundle branch block;
- obligate use of a cardiac pacemaker;
- congenital long QT syndrome;
- history or presence of ventricular tachyarrhythmia;
- presence of unstable atrial fibrillation (ventricular response > 100 bpm). -Patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria;
- clinically significant resting bradycardia (< 50 bpm);
- right bundle branch block + left anterior hemiblock (bifascicular block);
- angina pectoris ≤ 3 months prior to starting study drug;
- acute myocardial infarction (MI) ≤ 3 months prior to starting study drug; or
- other clinically significant heart disease (e.g., congestive heart failure (CHF), uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
- Patients currently receiving treatment with medications known to prolong the QTc interval and/or to induce Torsades de Pointes arrhythmia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-arm, Two-stage, Open-label Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma
This is a clinical research study that is designed to test the safety of CYT997 when given to patients with multiple myeloma and to test if CYT997 has any activity against that cancer.
- Conditions
- Relapsed and Refractory Multiple Myeloma
- Being tested
- CYT997
- Keywords
- Multiple myeloma, relapsed, refractory
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT997Drug
Intravenous infusion (24h); 202mg/m2 on days 1 and 8 of a 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | CYT997 Receives: Drug: CYT997 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma
The overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma once every 3 week cycle
Measured: Baseline to study completion
Secondary outcomes (4)
Number of cycles required to achieve maximum response
Measured: Baseline to study completion
Overall survival
Measured: Baseline to study completion
Safety and tolerability
Measured: Baseline to study completion
Time to disease progression
Measured: Baseline to study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Difficulty enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Spencer, Assoc Prof., Principal investigator, Myeloma Research Group, The Alfred Hospital, Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664378
- Sponsor's protocol ID
- CCL07001
- Status last verified
- Apr 2013
- First submitted
- 18 Apr 2008
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Two-stage, Open-label Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00664378
- Acronym / sponsor ID
- CCL07001
- Conditions
- Relapsed and Refractory Multiple Myeloma
- Keywords
- Multiple myeloma, relapsed, refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 Apr 2008 (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 is a clinical research study that is designed to test the safety of CYT997 when given to patients with multiple myeloma and to test if CYT997 has any activity against that cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: CYT997CYT997 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of multiple myeloma per International Working Group (IWG) criteria
- Have received at least 1 but no more than 4 prior lines of therapy
- Have failed to respond to the most recently administered anti-myeloma therapy
- Have a life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status < 3
Key exclusion criteria (27 listed)
- Patients with monoclonal gammopathy of undetermined significance
- Known or suspected hypersensitivity to CYT997
- Patient with uncontrolled intercurrent illness
- Active infections or other illnesses that precludes chemotherapy administration or patient compliance.
- Pregnant or lactating women.
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 |
|---|---|---|
| CYT997Intravenous infusion (24h); 202mg/m2 on days 1 and 8 of a 21 day cycle | Drug | I |
Primary outcome
Overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma
Time frame: Baseline to study completion
The overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma once every 3 week cycle
4 secondary outcomes
Number of cycles required to achieve maximum response
Time frame: Baseline to study completion
Overall survival
Time frame: Baseline to study completion
Safety and tolerability
Time frame: Baseline to study completion
Time to disease progression
Time frame: Baseline to study completion
Results and safety
The study was stopped early (reason given: Difficulty enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
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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.
Andrew Spencer, Assoc Prof. principal investigator
Myeloma Research Group, The Alfred Hospital, Melbourne
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 CYT997 in people with Relapsed and Refractory Multiple Myeloma, run by Gilead Sciences at 1 site in Australia.
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 9 inclusion and 27 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 Jun 2018. 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 Australia. 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: Difficulty enrolling 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 to CYT997 when used to treat patients with relapsed or refractory multiple myeloma (time frame: Baseline to study completion). 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 Jun 2018.