A Phase II Study of AT9283 in Patients With Relapsed or Refractory Multiple Myeloma
- 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.
- 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
- 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