Viral Immunotherapy in Relapsed/Refractory Multiple Myeloma (MUKeleven)

January 21, 2020 updated by: Gordon Cook, University of Leeds

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom
        • St James's University Hospital
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lenalidomide or pomalidomide, plus REOLYSIN

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.
Drug: Lenalidomide or Pomalidomide
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).
Biological: REOLYSIN
Patients will receive Reolysin alongside either lenalidomide or pomalidomide
Other Names:
  • Pelareorep
  • Reovirus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After cycle 1 (28 days) of treatment. Assessed in real-time for each patient to inform dose escalation decisions.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 will be reported based on the occurrence of SAEs, SARs and SUSARs.
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.
Safety will be reported based on the occurrence of SAEs, SARs and SUSARs.
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 will be reported 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 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.
Toxicity will be reported 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 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.
Measured only in patients treated at the maximum tolerated dose
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.
Measured only in patients treated at the maximum tolerated dose
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.
Measured only in patients treated at the maximum tolerated dose
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.
Measured only in patients treated at the maximum tolerated dose
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.
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.
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.
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.
Calculated for each patient from the date of registration to death. Assessed up to 27 months.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immune response biomarker profile of REOLYSIN and lenalidomide administered in combination
Time Frame: This will be assessed based on samples taken throughout each patient's time on the trial. Assessed up to 27 months.
Biomarker profiling of the combination treatment
This will be assessed based on samples taken throughout each patient's time on the trial. Assessed up to 27 months.
Immune response biomarker profile of REOLYSIN® and pomalidomide administered in combination
Time Frame: This will be assessed based on samples taken throughout each patient's time on the trial. Assessed up to 27 months.
Biomarker profiling of the combination treatment
This will be assessed based on samples taken throughout each patient's time on the trial. Assessed up to 27 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leeds

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Celgene Corporation
Oncolytics Biotech
Myeloma UK

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gordon Cook, St. James's University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM16/118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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