Myeloma MultiplePhase 1/2MUKfourteenNCT03191981
Pembrolizumab Cyclophosphamide and Lenalidomide for Patients With Relapsed Multiple Myeloma
A Phase 1/2 study testing Cyclophosphamide, Lenalidomide and Pembrolizumab in people with Myeloma Multiple, run by University of Leeds at 4 sites in United Kingdom.
Trial summary
This is a multi-centre phase I/II trial with an initial dose finding phase for cyclophosphamide and lenalidomide combined with fixed dose pembrolizumab for patients with relapsed or relapsed / refractory multiple myeloma (MM) that have had at least 1 prior line of therapy Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myeloma Multiple
- What is being tested?
- Cyclophosphamide, Lenalidomide and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Aug 2017to 1 Aug 2017
- Phase
- Phase 1/2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent for the trial and willing to follow the trial protocol.
- Be 18 years of age or greater on day of signing informed consent.
- Measurable disease with at least one of the following:
- Paraprotein greater than or equal to 5g/L
- Serum free light chains greater than or equal to 100mg/L with abnormal radio for light chain only
- myeloma
Show all 25Show fewer
- Bence Jones protein greater than or equal to 200mg/24hr
- Have relapsed MM following 1 or more prior lines of therapy.
- Have achieved a partial response (PR or better based on investigator's determination of response by the International Myeloma Working Group (IMWG) criteria) to at least one prior regimen
- Have a performance status of 0-1 on the ECOG Performance Scale.
- Demonstrate adequate organ function as defined below, all screening laboratory tests are to be performed within 10 days prior to registration:
- Haematological
- Absolute neutrophil count greater than or equal to 1.0 x109 /L. Growth factor support is not permitted within 7 days prior to assessment
- Platelet count greater than or equal to 75 x 109/L. Platelet support is not permitted within 7 days prior to assessment.
- Haemoglobin greater than or equal to 90 g/L. Blood support is not permitted within 7 days prior to assessment.
- Renal
- Serum creatinine or, measured or calculated creatinine clearance less than or equal to 1.5 x local ULN OR Creatinine Clearance greater than or equal to 60 mL/min for participant with creatinine levels greater than 1.5 x local ULN Hepatic
- Serum bilirubin less than or equal to 1.5 x local ULN OR direct bilirubin less than or equal to local ULN for participants with total bilirubin levels greater than 1.5 x local ULN
- Aspartate transaminase (AST) or Alanine transaminase (ALT) less than or equal to 2.5 x local ULN
- Albumin greater than or equal to 2.5 mg/dL (25 g/L) Coagulation
- International Normalized Ratio (INR) or Prothrombin Time (PT) less than or equal to1.5 x local ULN, unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- The standard Celgene Revlimid REMS program must be followed for all participants taking part in the trial and followed accordingly. In addition the following must also be followed:
- Female participant of childbearing potential should have a negative urine or serum pregnancy test. Female participants of childbearing potential must be willing to use adequate methods of contraception, from 4 weeks prior to the start of treatment, until 120 days after the last dose of trial medication, and for all interruptions in dosing during the trial.
- Male participants of childbearing potential must agree to use adequate methods of contraception from 4 weeks prior to the start of treatment, until 120 days after the last dose of trial medication, and for all interruptions in dosing during the trial.
- All participants must agree to refrain from donation blood while on trial drug, including during dose interruptions and for 120 days after discontinuation from this trial
Who cannot join
- Those with non-measurable disease, solitary bone or solitary extramedullary plasmacytoma, plasma cell leukaemia, POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Is currently participating and receiving trial therapy, or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 28 days prior to the first dose of trial treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. Steroids for myeloma disease control must be stopped 14 days prior to the first dose of trial treatment.
- If previously treated with a lenalidomide-containing regimen, the participant is excluded if:
- Discontinued due to any adverse event related to prior lenalidomide (history of thromboembolism due to lenalidomide is allowed if participant is anticoagulated)
- If the participant was intolerant to lenalidomide.
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- If the participant was refractory to any dose of lenalidomide. Refractory to lenalidomide is defined either:
- Participant had disease progression within 60 days after the last dose of lenalidomide; or Whose disease is non-responsive whilst on lenalidomide. Non-responsive disease is defined as either not achieving at least an minimal response (MR) or progressive disease (PD) whilst on lenalidomide.
- Any of the following prior treatments:
- Has had a prior allogenic stem cell transplant. Previous autologous stem cell transplantation is permitted greater than or equal to 3 months prior to the first dose of trial treatment.
- Previous therapy with pembrolizumab or has received prior therapy with an anti-PD-1, L1 or L2 inhibitor.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first dose of trial treatment or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- o Has had prior chemotherapy, targeted small molecule therapy, therapeutic radiation therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent. Participants with less than ore equal to Grade 2 neuropathy are an exception to this criterion and may participant in the trial.
- Treatment with plasmapheresis within 4 weeks prior to the first dose of trial treatment.
- Palliative radiotherapy for pain control and bisphosphonates are permitted
- A known hypersensitivity or intolerance to cyclophosphamide or lenalidomide or any of its excipients.
- If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Unable to tolerate thromboembolic prophylaxis including, as clinically indicated, aspirin, warfarin or low-molecular weight heparin.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has known active central nervous system (CNS) myeloma and/or carcinomatous meningitis. Participants with previously treated CNS myeloma may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging CNS disease, and are not using steroids for at least 14 days prior to the first dose of trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Significant cardiac disease as determined by the investigator including:
- Known or suspected cardiac amyloidosis
- Congestive heart failure of Class III or IV of the New York Heart Association (NYHA) classification;
- Uncontrolled angina, hypertension or arrhythmia
- Myocardial infarction in past 6 months
- Any uncontrolled or severe cardiovascular disease
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has an active infection requiring systemic therapy.
- Has a known history of active TB (Bacillus Tuberculosis)
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 28 days prior to the first dose of trial treatment.
- Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the duration of their involvement in the trial, starting with the 4 weeks prior to starting trial treatment, during trial treatment including during any treatment interruptions until 120 days after the last dose of trial treatment.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
University College Hospital
London, NW1 2BU
Guys and St Thomas NHS Foundation Trust
London, SE1 9RT
Southampton General Hospital
Southampton, SO16 6YD
About this study
Official title: A Phase I/II Trial Investigating the Combination of Pembrolizumab (Keytruda) With Cyclophosphamide and Lenalidomide for Patients With Relapsed Multiple Myeloma
This is a multi-centre phase I/II trial with an initial dose finding phase for cyclophosphamide and lenalidomide combined with fixed dose pembrolizumab for patients with relapsed or relapsed / refractory multiple myeloma (MM) that have had at least 1 prior line of therapy
Read the detailed description
This is a multi-centre phase I/II trial with an initial dose finding phase for cyclophosphamide and lenalidomide combined with fixed dose pembrolizumab for patients with relapsed or relapsed / refractory MM that have had at least one prior line of therapy.
As this combination has not been given before, participants will be registered initially into a dose finding phase where dose limiting toxicities (DLTs) will be monitored during the first cycle in order to confirm the recommended dose schedule (RD) of cyclophosphamide with lenalidomide and fixed dose pembrolizumab. A modified toxicity probability interval (mTPI) approach has been taken for dose finding, to determine a safe dose schedule defined as the probability of dose limiting toxicity below an acceptable rate of 34%.
Once a RD is identified an expansion phase is planned to estimate the activity profile of the Key-CR combination at the RD. The trial will start at the highest dose schedule . Cohorts of 3 evaluable participants will sequentially be recruited to the trial until the RD has been identified or the trial stopped due to excessive toxicity at dose schedule -1. The dose schedule to be given to a subsequent cohort will be evaluated after all participants have been followed up for one cycle or experienced a DLT. The Safety Review Committee (SRC) will be presented with a complete safety report in addition to a set of predetermined dosing decisions, such that all relevant information available may be considered before deciding upon the next dose schedule to be allocated.
The mTPI is an adaptive Bayesian design specifying that the parameter for the probability that a patient experiences a DLT during the first cycle follows a separate distribution for each dose level. Each DLT probability is believed to be equally likely to take any value between 0 and 1 before any data is collected this represents a non-informative or flat prior. The posterior distribution from which escalation decisions are made is constructed by updating the prior distribution with observed data and represents our updated beliefs about the parameter after having seen the data. The decision to remain at the current dose schedule (S), escalate (E), or de-escalate (D) from the posterior distribution is determined by probability theory and two clinical criteria; the minimum DLT rate that if true would warrant escalation and the maximum DLT rate that if true would warrant dose de-escalation. The clinical interval is specified to be (0.2, 0.34) in this setting. Below 0.2 would represent under-dosing and warrant escalation, above 0.34, over-dosing and de-escalation and in the interval proper dosing and the decision to remain at the current dose level.
Participants will be registered to a dose schedule in cohorts of 3 evaluable participants and a decision regarding expansion or dose (de)escalation will be made once all patients have been followed up for the full DLT observation period (see below).
A minimum of 6 participants must be evaluated at a dose schedule for the dose schedule to be considered the RD. If dose schedule -1 or 0 meet the RD criterion but the dose schedule above has not been excluded, a further cohort of participants may be treated at the dose schedule above at discretion of the SRC. If dose schedule -1 is found to be unsafe the trial will terminate early without opening the expansion phase. The SRC may consider increasing the size of cohorts after 12 evaluable participants have been treated at a dose schedule without identifying the RD. Once the RD has been identified the trial will move into the expansion phase.
It is essential that the data for each participant is returned in a timely manner to allow the participants to be monitored for safety and dose limiting toxicities that could affect the safety of other participants. Data must be returned on time to allow a timely review of the trial by the Safety Review Committee to prevent a hold up in progressing the trial to the next phase or dose level, or to allow it to be stopped quickly in the event of an unforeseen issue occurring.
Dose Schedules - 28 days schedule Dose schedule 1 (starting dose) Pembrolizumab 200mg every 3 weeks, cyclophosphamide 500mg days 1\&8, lenalidomide 25mg days 1-21 Dose schedule 0 Pembrolizumab 200mg every 3 weeks, cyclophosphamide 500mg day 1, lenalidomide 25mg days 1-21 Dose schedule -1 Pembrolizumab 200mg every 3 weeks, cyclophosphamide 500mg day 1, lenalidomide 15mg days 1-21
- Conditions
- Myeloma Multiple
- Being tested
- Cyclophosphamide, Lenalidomide, Pembrolizumab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Treatment for all patients will be with cyclophosphamide, lenalidomide and pembrolizumab at fixed doses.
LenalidomideDrug
Also called Revlimid
Treatment for all patients will be with cyclophosphamide, lenalidomide and pembrolizumab at fixed doses.
PembrolizumabDrug
Also called Keytruda
Treatment for all patients will be with cyclophosphamide, lenalidomide and pembrolizumab at fixed doses.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Cyclophosphamide and lenalidomide combined with fixed dose pembrolizumab Receives: Drug: Cyclophosphamide; Drug: Lenalidomide; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT) in dose finding phase
Number of participants experiencing DLTs within the first cycle of treatment
Measured: End of cycle 1 of treatment, 4 weeks
Response rate
Overall response rate to treatment
Measured: From registration until disease progression, 2 years
Secondary outcomes (6)
Safety of trial treatment
The proportion of patients experiencing at least one serious adverse event (SAE) summarising causality and seriousness.
Measured: From registration until the end of the trial, 2 years
Progression free survival (PFS)
The proportion of patients being progression free
Measured: From registration to 6 & 12 months
Maximum response
Maximum response achieved in response to treatment
Measured: From the start of treatment until the end of treatment, 2 years
Duration of response
Time for which a response to treatment was seen
Measured: From start of treatment until disease progression, 2 years
Compliance to therapy
Number of patients requiring delays and/or dose reductions, treatment withdrawals.
Measured: From start of treatment until the end of treatment, 2 years
Toxicity of trial treatment
Adverse events seen during treatment, indicating toxicity of treatment
Measured: From start of treatment until the end of treatment, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Aug 2017
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Why it stopped: Withdrawal of pharma support prior to opening to recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma MultipleStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I/II trial with an initial dose finding phase for cyclophosphamide and lenalidomide combined with fixed dose pembrolizumab
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Myeloma UK, Karyopharm Therapeutics Inc
- Responsible party
- Sponsor
- Investigators
- Rakesh Popat, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191981
- Sponsor's protocol ID
- HM16/87650
- Acronym
- MUKfourteen
- Status last verified
- Aug 2017
- First submitted
- 24 May 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be disseminated by trial publication and a final report
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial Investigating the Combination of Pembrolizumab (Keytruda) With Cyclophosphamide and Lenalidomide for Patients With Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03191981
- Acronym / sponsor ID
- MUKfourteen / HM16/87650
- Conditions
- Myeloma Multiple
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawal of pharma support prior to opening to recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Myeloma UK, Karyopharm Therapeutics Inc
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 19 Jun 2017 (actual)
- 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 is a multi-centre phase I/II trial with an initial dose finding phase for cyclophosphamide and lenalidomide combined with fixed dose pembrolizumab for patients with relapsed or relapsed / refractory multiple myeloma (MM) that have had at least 1 prior line of therapy
Detailed description
This is a multi-centre phase I/II trial with an initial dose finding phase for cyclophosphamide and lenalidomide combined with fixed dose pembrolizumab for patients with relapsed or relapsed / refractory MM that have had at least one prior line of therapy.
As this combination has not been given before, participants will be registered initially into a dose finding phase where dose limiting toxicities (DLTs) will be monitored during the first cycle in order to confirm the recommended dose schedule (RD) of cyclophosphamide with lenalidomide and fixed dose pembrolizumab. A modified toxicity probability interval (mTPI) approach has been taken for dose finding, to determine a safe dose schedule defined as the probability of dose limiting toxicity below an acceptable rate of 34%.
Once a RD is identified an expansion phase is planned to estimate the activity profile of the Key-CR combination at the RD. The trial will start at the highest dose schedule . Cohorts of 3 evaluable participants will sequentially be recruited to the trial until the RD has been identified or the trial stopped due to excessive toxicity at dose schedule -1. The dose schedule to be given to a subsequent cohort will be evaluated after all participants have been followed up for one cycle or experienced a DLT. The Safety Review Committee (SRC) will be presented with a complete safety report in addition to a set of predetermined dosing decisions, such that all relevant information available may be considered before deciding upon the next dose schedule to be allocated.
The mTPI is an adaptive Bayesian design specifying that the parameter for the probability that a patient experiences a DLT during the first cycle follows a separate distribution for each dose level. Each DLT probability is believed to be equally likely to take any value between 0 and 1 before any data is collected this represents a non-informative or flat prior. The posterior distribution from which escalation decisions are made is constructed by updating the prior distribution with observed data and represents our updated beliefs about the parameter after having seen the data. The decision to remain at the current dose schedule (S), escalate (E), or de-escalate (D) from the posterior distribution is determined by probability theory and two clinical criteria; the minimum DLT rate that if true would warrant escalation and the maximum DLT rate that if true would warrant dose de-escalation. The clinical interval is specified to be (0.2, 0.34) in this setting. Below 0.2 would represent under-dosing and warrant escalation, above 0.34, over-dosing and de-escalation and in the interval proper dosing and the decision to remain at the current dose level.
Participants will be registered to a dose schedule in cohorts of 3 evaluable participants and a decision regarding expansion or dose (de)escalation will be made once all patients have been followed up for the full DLT observation period (see below).
A minimum of 6 participants must be evaluated at a dose schedule for the dose schedule to be considered the RD. If dose schedule -1 or 0 meet the RD criterion but the dose schedule above has not been excluded, a further cohort of participants may be treated at the dose schedule above at discretion of the SRC. If dose schedule -1 is found to be unsafe the trial will terminate early without opening the expansion phase. The SRC may consider increasing the size of cohorts after 12 evaluable participants have been treated at a dose schedule without identifying the RD. Once the RD has been identified the trial will move into the expansion phase.
It is essential that the data for each participant is returned in a timely manner to allow the participants to be monitored for safety and dose limiting toxicities that could affect the safety of other participants. Data must be returned on time to allow a timely review of the trial by the Safety Review Committee to prevent a hold up in progressing the trial to the next phase or dose level, or to allow it to be stopped quickly in the event of an unforeseen issue occurring.
Dose Schedules - 28 days schedule Dose schedule 1 (starting dose) Pembrolizumab 200mg every 3 weeks, cyclophosphamide 500mg days 1\&8, lenalidomide 25mg days 1-21 Dose schedule 0 Pembrolizumab 200mg every 3 weeks, cyclophosphamide 500mg day 1, lenalidomide 25mg days 1-21 Dose schedule -1 Pembrolizumab 200mg every 3 weeks, cyclophosphamide 500mg day 1, lenalidomide 15mg days 1-21
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I/II trial with an initial dose finding phase for cyclophosphamide and lenalidomide combined with fixed dose pembrolizumab
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Cyclophosphamide, Drug: Lenalidomide, Drug: PembrolizumabCyclophosphamide and lenalidomide combined with fixed dose pembrolizumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Be willing and able to provide written informed consent for the trial and willing to follow the trial protocol.
- Be 18 years of age or greater on day of signing informed consent.
- Measurable disease with at least one of the following:
- Have relapsed MM following 1 or more prior lines of therapy.
- Have achieved a partial response (PR or better based on investigator's determination of response by the International Myeloma Working Group (IMWG) criteria) to at least one prior regimen
Key exclusion criteria (37 listed)
- Those with non-measurable disease, solitary bone or solitary extramedullary plasmacytoma, plasma cell leukaemia, POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Is currently participating and receiving trial therapy, or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 28 days prior to the first dose of trial treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. Steroids for myeloma disease control must be stopped 14 days prior to the first dose of trial treatment.
- If previously treated with a lenalidomide-containing regimen, the participant is excluded if:
- Participant had disease progression within 60 days after the last dose of lenalidomide; or Whose disease is non-responsive whilst on lenalidomide. Non-responsive disease is defined as either not achieving at least an minimal response (MR) or progressive disease (PD) whilst on lenalidomide.
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 |
|---|---|---|
| CyclophosphamideTreatment for all patients will be with cyclophosphamide, lenalidomide and pembrolizumab at fixed doses. | Drug | Treatment |
| LenalidomideAlso: RevlimidTreatment for all patients will be with cyclophosphamide, lenalidomide and pembrolizumab at fixed doses. | Drug | Treatment |
| PembrolizumabAlso: KeytrudaTreatment for all patients will be with cyclophosphamide, lenalidomide and pembrolizumab at fixed doses. | Drug | Treatment |
Primary outcome
Dose Limiting Toxicities (DLT) in dose finding phase
Time frame: End of cycle 1 of treatment, 4 weeks
Number of participants experiencing DLTs within the first cycle of treatment
Response rate
Time frame: From registration until disease progression, 2 years
Overall response rate to treatment
6 secondary outcomes
Safety of trial treatment
Time frame: From registration until the end of the trial, 2 years
Progression free survival (PFS)
Time frame: From registration to 6 & 12 months
Maximum response
Time frame: From the start of treatment until the end of treatment, 2 years
Duration of response
Time frame: From start of treatment until disease progression, 2 years
Compliance to therapy
Time frame: From start of treatment until the end of treatment, 2 years
Toxicity of trial treatment
Time frame: From start of treatment until the end of treatment, 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Individual participant dataSharing planned: No. To be disseminated by trial publication and a final report
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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.
Rakesh Popat principal investigator
University College, London
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyclophosphamide, Lenalidomide and Pembrolizumab in people with Myeloma Multiple, run by University of Leeds at 4 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 25 inclusion and 37 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: withdrawn, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 (DLT) in dose finding phase (time frame: End of cycle 1 of treatment, 4 weeks). The study lists 2 primary outcomes in all. 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 24 Aug 2017.