MUK eleven: Viral Immunotherapy in Relapsed/Refractory Multiple Myeloma
| ISRCTN | ISRCTN14749537 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14749537 |
| EudraCT/CTIS number | 2016-001564-11 |
| Secondary identifying numbers | 31775 |
- Submission date
- 09/01/2017
- Registration date
- 11/01/2017
- Last edited
- 17/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Mrs Debbie Sharratt
Public
Public
University of Leeds
Leeds
LS2 9JT
United Kingdom
Study information
| Study design | Non-randomised; Interventional; Design type: Treatment, Drug, Immunotherapy |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | VIRel: Viral immunotherapy in Relapsed/Refractory Multiple Myeloma - A Phase I Study to Assess the Safety and Tolerability of REOLYSIN® (pelareorep) in Combination with Lenalidomide or Pomalidomide |
| Study acronym | MUK eleven |
| Study hypothesis | To main aim of this study is to determine the Maximum Tolerated Doses (MTDs) of REOLYSIN® in combination with lenalidomide or pomalidomide in two separate groups of patients with multiple myeloma demonstrating evidence of serological disease progression. |
| Ethics approval(s) | Yorkshire & The Humber - Leeds West Research Ethics Committee, 09/11/2016, ref: 16/YH/0388 |
| Condition | Specialty: Cancer, Primary sub-specialty: Haematological Oncology; UKCRC code/ Disease: Cancer/ Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue |
| Intervention | 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 trial. Treatment will be given in cycles lasting 28 days in the following schedule: Lenalidomide or pomalidomide - oral, on days 1-21 REOLYSIN® - intravenous infusion over 1 hour on days 1, 8, 15 and 22 Treatment will last until the participant’s multiple myeloma progresses, their doctor decides it is necessary to stop treatment or until the participant decides they do not want any more treatment within the study. The frequency of follow-up visits will be decided by the participant’s doctor but we will continue to collect data for up to 3 years. |
| Intervention type | Other |
| Primary outcome measure | Dose-limiting toxicities are measured in real-time for each patient to inform dose escalation decisions after cycle 1 (28 days) of treatment. |
| Secondary outcome measures | 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. |
| Overall study start date | 30/06/2015 |
| Overall study end date | 01/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 44; UK Sample Size: 44 |
| Total final enrolment | 4 |
| Participant 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 < 70 but ≥ 25 acceptable if bone marrow is > 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 |
| Participant 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 |
| Recruitment start date | 01/02/2017 |
| Recruitment end date | 01/11/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Leeds
LS9 7TF
United Kingdom
Sponsor information
University of Leeds
University/education
University/education
Research and Development
34 Hyde Terrace
Leeds
LS2 9LN
England
United Kingdom
| Phone | +44 113 392 6459 |
|---|---|
| c.e.skinner@leeds.ac.uk | |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Charity
Myeloma UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 17/11/2022: The study will not be published unfortunately. Previous publication and dissemination plan: Plans to publish study results in a peer-reviewed journal around one year after the end of the trial. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available on request from the CTRU CARP Programme (carp@leeds.ac.uk). Raw data will be provided and will be available from now for 25 years. The researchers will accept proposals from ethically approved academic and commercial projects, consent has been obtained from participants for future research, and the data will be anonymised before being transferred. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | version 1.0 | 17/11/2022 | 17/11/2022 | No | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
17/11/2022: The following changes were made to the trial record:
1. The basic results of this trial have been uploaded as an additional file.
2. The publication and dissemination plan was updated.
3. Total final enrolment and IPD sharing statement added.
16/01/2018: Cancer Help UK lay summary link added to plain English summary field.
16/10/2017: Internal review.
15/09/2017: Internal review.
06/06/2017: Internal review.
