Multiple MyelomaPhase 1MUKelevenNCT03015922
Viral Immunotherapy in Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing Lenalidomide or Pomalidomide and REOLYSIN in people with Multiple Myeloma, run by University of Leeds at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Lenalidomide or Pomalidomide and REOLYSIN
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 Jun 2017to 1 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with symptomatic multiple myeloma (according to IMWG 2014 criteria)
- Evaluable disease by modified IMWG criteria (i.e. by abnormal serum M protein, urinary M protein or serum free light chain assays)
- 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)
- Life expectancy of ≥ 3 months
- ECOG performance status of ≤2
- Required laboratory values within 14 days prior to dose allocation:
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- Absolute neutrophil count ≥ 1.0 x10^9 /L. (growth factor support is not permitted)
- Platelet count ≥ 70 x 10^9/L. (platelet support is not permitted; platelets < 70 but ≥ 25 acceptable if bone marrow is > 50% infiltrated by MM)
- Haemoglobin ≥ 8 g/dL. Blood support is permitted
- Serum bilirubin ≤ 2 x upper limit of normal (ULN)
- ALT or AST ≤ 2.5 x ULN
- Serum creatinine ≤ 2 x ULN
- Corrected calcium ≤ 2.8 mmol/l
- Negative HIV and viral (B and C) hepatitis test result within 14 days prior to dose allocation
- Able to give informed consent and willing to follow trial protocol
- Aged 18 years or over
- All participants must agree to follow the Celgene Pregnancy Prevention Programme (PPP) and participate in the counselling associated with this:
- 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
- Females must agree to abstain from breastfeeding during trial participation and 28 days after trial drug discontinuation
- 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
- 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
- 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
Who cannot join
- Non-secretory multiple myeloma
- Pregnant (positive pregnancy test) in line with the Celgene Pregnancy Prevention Programme or breast feeding
- 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
- 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
- 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.
- Any history of known hypersensitivity to any of the trial medications or excipients
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- Active symptomatic fungal, bacterial, and/or viral infection
- 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
- 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)
- Radiotherapy or major surgery within 4 weeks prior to registration
- Greater than or equal to grade 2 neuropathy, with or without pain
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St James's University Hospital
Leeds
Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital
Sheffield
About this study
Official 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
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.
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide or Pomalidomide, REOLYSIN
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide or PomalidomideDrug
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).
REOLYSINBiological
Also called Pelareorep, Reovirus
Patients will receive Reolysin alongside either lenalidomide or pomalidomide
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide or pomalidomide, plus REOLYSIN | Experimental | Lenalidomide capsules, oral, maximum 10mg daily on days 1-21 of 28-day cycles. OR Pomalidomide capsules, oral, maximum 1mg daily on days 1-21 of 28-day cycles.
Plus (all patients):
REOLYSIN® , intravenous infusion, maximum 3x10^10 TCID50 on days 1, 8, 15 and 22 of 28-day cycles. Receives: Drug: Lenalidomide or Pomalidomide; Biological: REOLYSIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After cycle 1 (28 days) of treatment. Assessed in real-time for each patient to inform dose escalation decisions.
Secondary outcomes (10)
Safety profile of REOLYSIN® and lenalidomide
Safety will be reported based on the occurrence of SAEs, SARs and SUSARs.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Calculated for each patient from the date of registration to death. Assessed up to 27 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start5 Jun 2017
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Myeloma UK, Oncolytics Biotech, Celgene Corporation
- Responsible party
- Principal investigator, Gordon Cook, The Leeds Teaching Hospitals NHS Trust
- Investigators
- Gordon Cook, Principal investigator, St. James's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015922
- Sponsor's protocol ID
- HM16/118
- Acronym
- MUKeleven
- Status last verified
- Jan 2020
- First submitted
- 16 Nov 2016
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03015922
- Acronym / sponsor ID
- MUKeleven / HM16/118
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Myeloma UK, Oncolytics Biotech, Celgene Corporation
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide or pomalidomide, plus REOLYSIN | Experimental | Drug: Lenalidomide or Pomalidomide, Biological: REOLYSINLenalidomide capsules, oral, maximum 10mg daily on days 1-21 of 28-day cycles. OR Pomalidomide capsules, oral, maximum 1mg daily on days 1-21 of 28-day cycles. Plus (all patients): REOLYSIN® , intravenous infusion, maximum 3x10^10 TCID50 on days 1, 8, 15 and 22 of 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Diagnosed with symptomatic multiple myeloma (according to IMWG 2014 criteria)
- Evaluable disease by modified IMWG criteria (i.e. by abnormal serum M protein, urinary M protein or serum free light chain assays)
- 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)
- Life expectancy of ≥ 3 months
- ECOG performance status of ≤2
Key exclusion criteria (11 listed)
- Non-secretory multiple myeloma
- Pregnant (positive pregnancy test) in line with the Celgene Pregnancy Prevention Programme or breast feeding
- 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
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenalidomide or PomalidomidePatients will received either lenalidomide or pomalidomide, depending on which drug they were receiving prior to the trial (they will receive the same as before). | Drug | Lenalidomide or pomalidomide, plus REOLYSIN |
| REOLYSINAlso: Pelareorep, ReovirusPatients will receive Reolysin alongside either lenalidomide or pomalidomide | Biological | Lenalidomide or pomalidomide, plus REOLYSIN |
Primary outcome
Dose-limiting toxicities
Time frame: After cycle 1 (28 days) of treatment. Assessed in real-time for each patient to inform dose escalation decisions.
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.
10 secondary outcomes
Safety profile of REOLYSIN® and lenalidomide
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
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
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
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
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
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
Time frame: Assessed for each patient after they have completed treatment on the trial. Assessed up to 27 months.
Time to maximum response
Time frame: Assessed for each patient after they have completed treatment on the trial. Assessed up to 27 months.
Progression-free survival
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
Time frame: Calculated for each patient from the date of registration to death. Assessed up to 27 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon Cook principal investigator
St. James's University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenalidomide or Pomalidomide and REOLYSIN in people with Multiple Myeloma, run by University of Leeds at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (time frame: After cycle 1 (28 days) of treatment. Assessed in real-time for each patient to inform dose escalation decisions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.