Specialty: Cancer, Primary sub-specialty: Haematological Oncology
Conditions
Interventions
Participants will be treated with REOLYSIN® along with lenalidomide or pomalidomide, depending on which of these drugs they were
previously taking immediately before starting on the tr
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with symptomatic multiple myeloma (according to IMWG 2014 criteria) 2. Evaluable disease by modified IMWG criteria (i.e. by abnormal serum M protein, urinary M protein or serum free light chain assays) 3. Currently receiving either lenalidomide or pomalidomide therapy, alone or in combination with other myeloma therapy, with evidence of serological or clinical disease progression as defined by IMWG criteria (2011) 4. Life expectancy of = 3 months 5. ECOG performance status of =2 6. Required laboratory values within 14 days prior to dose allocation: 7. Absolute neutrophil count = 1.0 x109 /L. (growth factor support is not permitted) 8. Platelet count = 70 x 109/L. (platelet support is not permitted; platelets 50% infiltrated by MM) 9. Haemoglobin = 8 g/dL. Blood support is permitted 10. Serum bilirubin = 2 x upper limit of normal (ULN) 11. ALT or AST = 2.5 x ULN 12 Serum creatinine = 2 x ULN 13. Corrected calcium = 2.8 mmol/l 14. Negative HIV and viral (B and C) hepatitis test result within 14 days prior to dose allocation 15. Able to give informed consent and willing to follow trial protocol 16. Aged 18 years or over 17. All participants must agree to follow the Celgene Pregnancy Prevention Programme (PPP) and participate in the counselling associated with this: 18. Females of childbearing potential (FCBP) must agree to utilise two reliable forms of contraception simultaneously or practice complete abstinence for at least for 28 days prior to starting trial treatment, during the trial and for at least 28 days after trial treatment discontinuation, and even in case of dose interruption, and must agree to Celgene PPP pregnancy testing during this timeframe 19. Females must agree to abstain from breastfeeding during trial participation and 28 days after trial drug discontinuation 20. Males must agree to use a latex condom during any sexual contact with FCBP (or must practice complete abstinence) during the trial, including during dose interruptions and for 28 days following discontinuation from this trial even if he has undergone a successful vasectomy 21. Males must also agree to refrain from donating semen or sperm while on pomalidomide including during any dose interruptions and for 28 days after discontinuation from this trial 22. All participants must agree to refrain from donating blood while on trial drug including during dose interruptions and for 28 days after discontinuation from this trial
Exclusion criteria
Exclusion criteria: 1. Non-secretory multiple myeloma 2. Pregnant (positive pregnancy test) in line with the Celgene Pregnancy Prevention Programme or breast feeding 3. Previous anti-tumour therapies including experimental agents, other than lenalidomide or pomalidomide, within 28 days of the start of protocol treatment. Steroid therapy is permitted, but must be stopped 48 hours prior to cycle 1 day 1 4. Concurrent or previous malignancies (<12 months post end of treatment) at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer, or incidental histologic findings of prostate cancer (TNM stage T1a or 1b). Participants with histories (=12 months) of other tumours, in remission and not currently on therapy, may be entered. 5. System corticosteroid therapy for comorbidities (i.e. medical conditions other than multiple myeloma) that cannot be stopped for the duration of the trial. Topical corticosteroid therapy is not an exclusion criterion. 6. Any history of known hypersensitivity to any of the trial medications or excipients 7. Active symptomatic fungal, bacterial, and/or viral infection 8. Poorly controlled or serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical trial 9. Patients with significant cardiovascular disease (e.g. history of congestive heart failure requiring therapy (= NYHA Class III), presence of severe valvular heart disease, presence of an atrial or ventricular arrhythmia requiring treatment, uncontrolled hypertension, or history of QTc abnormalities) 10. Radiotherapy or major surgery within 4 weeks prior to registration 11. Greater than or equal to grade 2 neuropathy, with or without pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities are measured in real-time for each patient to inform dose escalation decisions after cycle 1 (28 days) of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety profile of REOLYSIN® and lenalidomide or pomalidomide is assessed based on the occurrence of SAEs, SARs and SUSARs until 28 days after the last dose of trial treatment for each patient 2. Toxicity profile of REOLYSIN® and lenalidomide or pomalidomide is assessed based on adverse events, as graded by CTCAE V4.0, and determined by routine clinical assessments at each centre until 28 days after the last dose of trial treatment for each patient 3. Response rate (stable disease or better) is measured using IMWG criteria after 6 cycles of therapy in patients treated at the maximum tolerated dose 4. Maximum response within 6 cycles of therapy is measured using IMWG criteria in patients treated at the maximum tolerated dose 5. Maximum response overall is measured using IMWG criteria in patients treated at the maximum tolerated dose when they have finished their treatment. 6. Time to maximum response in patients treated at the maximum tolerated dose is measured using IMWG criteria when they have finished their treatment 7. Progression-free survival is calculated for each patient from the date of registration up to first documented evidence of disease progression or death. Measured only in patients treated at the maximum tolerated dose 8. Overall survival is calculated for each patient from the date of registration to death. Measured only in patients treated at the maximum tolerated dose. Exploratory outcome measure: Immune response biomarker profile of REOLYSIN® and lenalidomide or pomalidomide administered in combination. | — |
Countries
England, United Kingdom
Contacts
Public ContactDebbie Sharratt
Outcome results
None listed