None listed
Conditions
Brief summary
The outcome in patients with Multiple myeloma (MM) who fail to respond to treatment or relapse after treatment is extremely poor. This study plans to treat approximately 80 patients in a number of sites throughout Australia and aims to investigate the effect of pomalidomide (a type of chemotherapy drug) on the immune system, and in turn, whether the outcomes of treatment with pomalidomide as single agent therapy for relapsed/refractory multiple myeloma (a blood cancer) are different to that achieved by patients treated with pomalidomide and dexamethasone (a steroid treatment commonly used in this disease) combination therapy. Who is it for? This study is open to male or female patients aged 18 or above with a diagnosis of MM and failing previous therapy, either refractory or relapsed after at least 2 previous lines of chemotherapy (including lenalidomide). The full details of the inclusion and exclusion criteria can be found in the relevant sections within this record. Trial details Initially, all patients will receive induction therapy consisting of four 28 day cycles of pomalidomide and dexamethasone. Patients then randomised to the pomalidomide arm for maintenance treatment will receive 4mg oral pomalidomide daily on a cyclic 21-day out of 28-day schedule for approximately 12 cycles. Patients randomised to the control arm for maintenance treatment will receive 4mg oral pomalidomide daily on a cyclic 21-day out of 28-day schedule along with 40mg oral dexamethasone on days 1, 8, 15, & 22 of 28 day cycle for approximately 12 cycles. For each arm of the study, the actual cycle number will be determined by the patient's treating clinician and based on response to and tolerability of treatment.
Interventions
All patients will receive 4mg oral pomalidomide daily on a cyclic 21-day out of 28-day schedule with 40mg oral dexamethasone on days 1, 8, 15, & 22 of 28 day cycle for 4 cycles as induction therapy. Patients randomised to the pomalidomide arm for maintenance treatment will receive 4mg oral pomalidomide daily on a cyclic 21-day out of 28-day schedule for approximately 12 cycles. Actual cycle number to be determined by treating clinician and based on response to and tolerability of treatment
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
At study entry: Diagnosed with relapsed and refractory mutiple myeloma (MM) (diagnosis of MM as per International Myeloma Working Group (IMWG)) -Measurable M-component (monoclonal protein) in serum or urine, -In patients with no detectable M-component, an abnormal Free light chain (FLC) ratio on the serum FLC assay At least 2 prior therapies: -Must include lenalidomide – failing to respond, disease progression during treatment or within 60 days of treatment completion (at least 2 cycles) -May include autologous stem cell transplant (ASCT) (induction/ASCT/maintenance is one line of therapy). Eastern Co-operative Oncology Group (ECOG) performance status 0-2 Adequate liver and kidney function (less than or equal to 2 x institutional upper limit of normal) Haemoglobin (Hb) greater than or equal to 80g/L, Platelet count greater than or equal to 75 x 10^9, absolute neutrophil count greater than or equal to 1.0 x 10^9. Subjects who fail screening due to neutropenia or anaemia will not be permitted to use growth factors to become eligible. No contraindication to the use of any of the study drugs No concomitant steroids other than dexamethasone outlined in this protocol Patient has voluntarily agreed and has given written informed consent. Life expectancy of > 8 weeks Patient must be greater than or equal to 4 weeks from prior chemotherapy, radiotherapy, biological therapy, immunotherapy, major surgery or any other investigational anti-cancer therapy prior to the first dose of study drug Patients to comply with lenalidomide Pregnancy Prevention Plan Study site must be able to get correlative samples to the Alfred Hospital, Melbourne, within 24 hours of collection. Prior to randomisation: Have completed 4 cycles of induction therapy Have no evidence of progressive MM
Exclusion criteria
At both registration and randomisation: Patients with monoclonal gammopathy of uncertain significance. Primary amyloidosis Patients who have received prior allogeneic transplantation < 12 months prior to entering study Patients who have had prior allogeneic transplantation and show evidence of active graft-versus-host disease that requires immunosuppressive therapy Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or lactating women. Known Hepatitis B, Hepatitis C, Human immunodeficiency virus (HIV) infection, other immunosuppressive therapy or autoimmune disease
Outcome results
None listed