This study will recruit patients currently receiving either lenalidomide or pomalidomide whose disease is relapsing. This is a dose escalation study and the aim is to determine the maximum tolerated dose (MTD) of REOLYSIN® that can be given in combination with lenalidomide or pomalidomide. The study will also investigate the safety, side effects and effectiveness of this treatment combination. Pomalidomide and lenalidomide will be evaluated separately as two separate groups.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Patients will received either lenalidomide or pomalidomide, depending on which drug they were receiving prior to the trial (they will receive the same as before).
Patients will receive Reolysin alongside either lenalidomide or pomalidomide
St James's University Hospital
Leeds, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital
Sheffield, United Kingdom
Dose-limiting toxicities
Dose-limiting toxicities (DLTs), within the first cycle (until cycle 2, day 1), in order to establish the Maximum Tolerated Dose (MTD) of REOLYSIN® in combination with lenalidomide or pomalidomide, in two separate groups of participants.
Time frame: After cycle 1 (28 days) of treatment. Assessed in real-time for each patient to inform dose escalation decisions.
Safety profile of REOLYSIN® and lenalidomide
Safety will be reported based on the occurrence of SAEs, SARs and SUSARs.
Time frame: Until 28 days after the last dose of trial treatment for each patient. Assessed up to 27 months.
Safety profile of REOLYSIN® and pomalidomide
Safety will be reported based on the occurrence of SAEs, SARs and SUSARs.
Time frame: Until 28 days after the last dose of trial treatment for each patient. Assessed up to 27 months.
Toxicity profile of REOLYSIN® and lenalidomide
Toxicity will be reported based on adverse events, as graded by CTCAE V4.0, and determined by routine clinical assessments at each centre.
Time frame: Until 28 days after the last dose of trial treatment fior each patient. Assessed up to 27 months.
Toxicity profile of REOLYSIN® and pomalidomide
Toxicity will be reported based on adverse events, as graded by CTCAE V4.0, and determined by routine clinical assessments at each centre.
Time frame: Until 28 days after the last dose of trial treatment fior each patient. Assessed up to 27 months.
Response rate (stable disease or better) after 6 cycles of therapy
Measured only in patients treated at the maximum tolerated dose
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Time frame: Data will be collected from each patient after they have received 6 cycles of therapy, if this stage is reached. 6 cycles are expected to take 24 weeks to complete.
Maximum response within 6 cycles of therapy
Measured only in patients treated at the maximum tolerated dose
Time frame: Assessed for each patient after they have received 6 cycles of treatment. 6 cycles are expected to take 24 weeks to complete.
Maximum response overall
Measured only in patients treated at the maximum tolerated dose
Time frame: Assessed for each patient after they have completed treatment on the trial. Assessed up to 27 months.
Time to maximum response
Measured only in patients treated at the maximum tolerated dose
Time frame: Assessed for each patient after they have completed treatment on the trial. Assessed up to 27 months.
Progression-free survival
Measured only in patients treated at the maximum tolerated dose. Participants who have not progressed at the time of analysis will be censored at the last date they were known to be alive and progression free.
Time frame: Calculated for each patient from the date of registration up to first documented evidence of disease progression or death. Assessed up to 27 months.
Overall survival
Measured only in patients treated at the maximum tolerated dose. Participants who have not died at the time of analysis will be censored at the last date they were known to be alive.
Time frame: Calculated for each patient from the date of registration to death. Assessed up to 27 months.