ACTRN12615000447550
Terminated
Phase 2
A 2-stage Phase II study evaluating the safety and efficacy of combination pomalidomide and low dose dexamethasone therapy in patients with relapsed myeloma previously treated wtih lenalidomide maintenance post Autologous Stem Cell Transplant (LEOPARD follow-on study)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Alfred Health
- Enrollment
- 30
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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