None listed
Conditions
Brief summary
This study aims to investigate whether ongoing treatment with prednisolone and dexamethasone can supress multiple myeloma as post-autograft maintenance therapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have received lenalidomide maintenance as part of the LEOPARD study as immediate therapy prior to relapse or progressive disease. Study details. All participants in this study will receive a therapy consisting of Pomalidomide and Dexamethasone. Both will be taken orally at a 28 day cycle, Pomalidomide at a dose of 4mg (starting dose) daily from Days 1 to 21, and Dexamethasone at a dose of 40mg (starting dose) weekly on Days 1, 8, 15, 22. Blood tests will be taken every cycle (28 days) to assess safety, tolerability and efficacy of the treatment. A bone marrow biopsy will be performed at the beginning of the study and whole body x-ray will be taken at the beginning and end of the study. Participants will be followed-up until they complete the study to determine response rates, survival and safety and toxicity of the this treatment.
Interventions
Pomalidomide will commence at a dose of 4mg orally daily from Days 1 to 21 of a 28 day cycle for the duration of the study, until disease progression or relapse
Dexamethasone will commence at a dose of 40mg weekly on Days 1, 8, 15 and 22 of a 28 day cycle for the duration of the study, until disease progression or relapse.
Adherence to protocol will be monitored via regular cycles visits to the trial centre for medical review and safety bloods and drug accountability in the form of drug return.
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18+ years of age and be able to give informed consent 2. Confirmed diagnosis of multiple myeloma with progressive disease as per IMWG criteria 3. Patients must have evaluable multiple myeloma with, at least of the following: - serum M-protein greater than or equal to 5g/L, or - urine M-protein greater than or equal to 200mg/24 hour, or - serum free light chain (SFLC) >100mg/L (involved light chain) and an abnormal kappa/lambda ratio (>4:1 or <2:1), or - for IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (total IgA) greater than or equal to 7.5g/L 4. Immediate therapy prior to relapse or progressive disease was lenalidomide maintenance as part of the LEOPARD study - Note: Patients who discontinued LEOPARD study due to reasons other than progression (such as toxicity, consent withdrawal) and have subsequent relapse may be eligible for inclusion 5. Life expectancy of > 16 weeks 6. Patient must be greater than or equal to 7 days from prior focal radiotherapy, and greater than or equal to 2 weeks from last dose of lenalidomide and/or prednisolone, and/or major surgery prior to the first dose of study drug. No other anti-myeloma therapy is given between cessation of RAP maintenance and commencement of Pomalidomide therapy. 7. Adequate organ function and absence of any other absolute contraindications to the use of pomalidomide or dexamethasone 8. ECOG performance status 0-2 9. All women of childbearing potential must agree to have a negative pregnancy test in the 24hrs before commencing pomalidomide, take adequate precautions to prevent pregnancy, and not plan on conceiving children during or within 6 months following pomalidomide 10. All males must use barrier contraception during and for 4 weeks after completing pomalidomide.
Exclusion criteria
N/A
Outcome results
None listed