Multiple MyelomaPhase 2NCT01145989
A Study of AT9283 in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing AT9283 in people with Multiple Myeloma, run by NCIC Clinical Trials Group at 6 sites in Canada.
Trial summary
The purpose of this study is to find out whether the new drug AT9283 will slow the growth of multiple myeloma. Side effects of AT9283 will also be closely monitored. 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?
- AT9283
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 6 sitesCanada
- Study dates
- 15 Feb 2011to 27 Nov 2015
- 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
- A confirmed diagnosis of multiple myeloma, according to the internationally accepted criteria for myeloma [International Myeloma Working Group 2003], must have been made prior to initial treatment.
- Patients must have measurable disease, according to the internationally accepted criteria for myeloma [Durie 2006].
- Age ≥ 18 years.
- ECOG performance status of 0, 1 or 2.
- Life expectancy > 3 months.
- Patients must have received prior treatment for multiple myeloma and have relapsed or progressed on prior therapy. There is no limit on number of prior treatment regimens, but patients must have completed prior treatment at least 4 weeks prior to registration (< 4 weeks permitted if prior therapy is non-myelosuppressive or if any treatment-related myelosuppression has resolved. Please call NCIC CTG for discussion). Patient must have recovered from any treatment related adverse events.
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- In patients with significant cardiac history or prior anthracycline exposure, Left Ventricular Ejection Fraction (LVEF) must be ≥ 50%.
- Prior radiation is permitted, but must have been completed at least 4 weeks prior to registration. Exceptions may be made for low dose, non-myelosuppressive radiotherapy after consultation with NCIC CTG.
- Laboratory Requirements: (must be within 7 days prior to registration) Hematology: Absolute granulocytes (AGC) ≥ 1.0 x 109/L Platelets ≥ 70 x 109/L Hemoglobin >100 g/L Biochemistry: Serum creatinine ≤ 1.5 x ULN Bilirubin normal AST and ALT ≤ 2 x upper normal limit Calcium normal
- In patients with significant cardiac history or prior anthrecycline exposure, left-ventricular ejection fraction (LVEF) must be ≥ 50%
- Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is provided. A copy of the initial REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to randomization or registration. Please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial.
- Investigators must assure themselves that the patients registered on this trial will be available for complete documentation of the treatment, toxicity, response assessment and follow-up.
- In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient registration.
Who cannot join
- Patients with uncontrolled hypertension (resting BP consistently higher than systolic > 140 mmHg and/or diastolic > 90 mmHg)
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, prostate cancer with stable PSA for ≥ 3 years, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
- Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to registration and must be using effective contraception throughout the study.
- Patients receiving concurrent treatment with other anti-cancer therapy.
- Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit that patient to be managed according to the protocol.
- Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) are not eligible.
- Patients with uncontrolled hypertension (resting BP> 140 mmtlg and/or diastolic > 90 mmtlg.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 1V7
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
Atlantic Health Sciences Corporation
Saint John, New Brunswick, E2L 4L2
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase II Study of AT9283 in Patients With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to find out whether the new drug AT9283 will slow the growth of multiple myeloma. Side effects of AT9283 will also be closely monitored.
- Conditions
- Multiple Myeloma
- Being tested
- AT9283
- Keywords
- Relapsed or Refractory Multiple Myeloma
- 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.
AT9283Drug
Starting dose will be 40 mg/m2/day OR 30 mg/m2/day to be confirmed at registration. IV 24 hour continuous infusion Days 1 and 8 every three weeks
| Study group | Role | What they receive |
|---|---|---|
| AT9283 | Experimental | Starting dose will be 40 mg/m2/day OR 30 mg/m2/day to be confirmed at registration. IV 24 hour continuous infusion Days 1 and 8 every three weeks Receives: Drug: AT9283 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Measured: 3 years
Secondary outcomes (3)
Adverse effects of AT9283
Measured: 3 years
Evaluation of potential predictive and prognostic biomarkers (marrow, blood)
Measured: 3 years
Evaluation of disease-related symptoms including pain, fatigue, mucositis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study start15 Feb 2011
- Primary completion29 Oct 2014
- Study completion27 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- Astex Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Tony Reiman, Study chair, Atlantic Health Sciences Corporation, Saint John Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145989
- Sponsor's protocol ID
- I191
- Status last verified
- Apr 2020
- First submitted
- 15 Jun 2010
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hay AE, Murugesan A, DiPasquale AM, Kouroukis T, Sandhu I, Kukreti V, Bahlis NJ, Lategan J, Reece DE, Lyons JF, Sederias J, Xu H, Powers J, Seymour LK, Reiman T. A phase II study of AT9283, an aurora kinase inhibitor, in patients with relapsed or refractory multiple myeloma: NCIC clinical trials group IND.191. Leuk Lymphoma. 2016;57(6):1463-6. doi: 10.3109/10428194.2015.1091927. Epub 2015 Oct 15. No abstract available.
PubMed 26376958
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of AT9283 in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01145989
- Acronym / sponsor ID
- I191
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Collaborators
- Astex Pharmaceuticals, Inc.
- Study start
- 15 Feb 2011 (actual)
- Primary completion
- 29 Oct 2014 (actual)
- Study completion
- 27 Nov 2015 (actual)
- First posted
- 17 Jun 2010 (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 find out whether the new drug AT9283 will slow the growth of multiple myeloma. Side effects of AT9283 will also be closely monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AT9283 | Experimental | Drug: AT9283Starting dose will be 40 mg/m2/day OR 30 mg/m2/day to be confirmed at registration. IV 24 hour continuous infusion Days 1 and 8 every three weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- A confirmed diagnosis of multiple myeloma, according to the internationally accepted criteria for myeloma [International Myeloma Working Group 2003], must have been made prior to initial treatment.
- Patients must have measurable disease, according to the internationally accepted criteria for myeloma [Durie 2006].
- Age ≥ 18 years.
- ECOG performance status of 0, 1 or 2.
- Life expectancy > 3 months.
Key exclusion criteria (7 listed)
- Patients with uncontrolled hypertension (resting BP consistently higher than systolic > 140 mmHg and/or diastolic > 90 mmHg)
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, prostate cancer with stable PSA for ≥ 3 years, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
- Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to registration and must be using effective contraception throughout the study.
- Patients receiving concurrent treatment with other anti-cancer therapy.
- Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit that patient to be managed according to the protocol.
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 |
|---|---|---|
| AT9283Starting dose will be 40 mg/m2/day OR 30 mg/m2/day to be confirmed at registration. IV 24 hour continuous infusion Days 1 and 8 every three weeks | Drug | AT9283 |
Primary outcome
Overall Response Rate
Time frame: 3 years
3 secondary outcomes
Adverse effects of AT9283
Time frame: 3 years
Evaluation of potential predictive and prognostic biomarkers (marrow, blood)
Time frame: 3 years
Evaluation of disease-related symptoms including pain, fatigue, mucositis
Time frame: 3 years
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 4 Aug 2023.
- Results publication: PubMed 26376958Hay AE, Murugesan A, DiPasquale AM, Kouroukis T, Sandhu I, Kukreti V, Bahlis NJ, Lategan J, Reece DE, Lyons JF, Sederias J, Xu H, Powers J, Seymour LK, Reiman T. A phase II study of AT9283, an aurora kinase inhibitor, in patients with relapsed or refractory multiple myeloma: NCIC clinical trials group IND.191. Leuk Lymphoma. 2016;57(6):1463-6. doi: 10.3109/10428194.2015.1091927. Epub 2015 Oct 15. No abstract available.
- Individual participant dataSharing planned: No
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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.
Tony Reiman study chair
Atlantic Health Sciences Corporation, Saint John Regional Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AT9283 in people with Multiple Myeloma, run by NCIC Clinical Trials Group at 6 sites in Canada.
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 14 inclusion and 7 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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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.
What does the primary outcome measure?
Overall Response Rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01145989, which also lists 1 linked publication.
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 4 Aug 2023.