The purpose of this study is to determine the maximum tolerated dose (MTD) and to evaluate the safety of cyclophosphamide when given on days 1 and 8 in a 28 day cycle in doses starting at 300mg ranging to 700mg in combination with Lenalidomide (Revlimid®) plus dexamethasone in patients who present with relapsed or refractory myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Oral lenalidomide 25mg daily on Days 1-21 every 28 days cycles for up to 9 cycles. From Cycle 10 Lenalidomide 25mg orally on days 1-21, every 28 days.
Dexamethasone 20mgs orally, daily on Days 1-4 and 8-11 repeated every 28 day cycles for up to 9 cycles.
Oral Cyclophosphamide will be added to the regime starting on days 1 and 8. The dose of Cyclophosphamide will be escalated in cohorts rising in 100mg increments from 300 to 700mgs days 1,and 8 every 28 day cycles for up to 9 cycles.
King's College Hospital NHS Foundation Trust
London, United Kingdom
Royal Marsden NHS Foundation Trust
London, United Kingdom
Dose limiting toxicity defined as: a) NCI Grade 4 haematological toxicity b) NCI Grade ¾ non-haematological toxicity
Time frame: Weekly for first cycle
Safety (type, frequency, severity, and relationship of adverse events)
Time frame: Weekly for first cycle then monthly
Time to progression
Time frame: Monthly
Paraprotein response
Time frame: Monthly
Bone marrow response
Time frame: Baseline, end of treatment and disease progression
Duration of response
Time frame: Monthly
Overall survival
Time frame: Monthly
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