A Study of AT9283 in Patients With Relapsed or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
AT9283
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Relapsed or Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Tom Baker Cancer Centre
- Cross Cancer Institute
- Atlantic Health Sciences Corporation
- QEII Health Sciences Center
- Juravinski Cancer Centre at Hamilton Health Sciences
- Univ. Health Network-Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AT9283
Arm Description
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
Outcomes
Primary Outcome Measures
Overall Response Rate
Secondary Outcome Measures
Adverse effects of AT9283
Evaluation of potential predictive and prognostic biomarkers (marrow, blood)
Evaluation of disease-related symptoms including pain, fatigue, mucositis
Full Information
NCT ID
NCT01145989
First Posted
June 15, 2010
Last Updated
August 3, 2023
Sponsor
NCIC Clinical Trials Group
Collaborators
Astex Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01145989
Brief Title
A Study of AT9283 in Patients With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase II Study of AT9283 in Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2011 (Actual)
Primary Completion Date
October 29, 2014 (Actual)
Study Completion Date
November 27, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group
Collaborators
Astex Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapsed or Refractory Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AT9283
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
AT9283
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall Response Rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Adverse effects of AT9283
Time Frame
3 years
Title
Evaluation of potential predictive and prognostic biomarkers (marrow, blood)
Time Frame
3 years
Title
Evaluation of disease-related symptoms including pain, fatigue, mucositis
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Reiman
Organizational Affiliation
Atlantic Health Sciences Corporation, Saint John Regional Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Atlantic Health Sciences Corporation
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
QEII Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Univ. Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26376958
Citation
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.
Results Reference
result
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A Study of AT9283 in Patients With Relapsed or Refractory Multiple Myeloma
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