- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02406222
Pomalidomide in Relapsed and Refractory Multiple Myeloma (RRMM) (MUKseven)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Belfast, United Kingdom, BT9 7AB
- Belfast Health & Social Care Trust
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Birmingham, United Kingdom, B9 5SS
- Birmingham Heartlands Hospital
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Birmingham, United Kingdom, B15 2TH
- University of Birmingham NHS Foundation Trust
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Brighton, United Kingdom, BN2 5BE
- Royal Sussex County Hospital
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Burton on Trent, United Kingdom, DE13 0RB
- Queens Hospital
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Cardiff, United Kingdom, CF14 4XW
- University Hospital of Wales NHS Trust
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Dundee, United Kingdom, DD1 9SY
- Ninewells Hospital
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Glasgow, United Kingdom
- Beatson Oncology Centre
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Leeds, United Kingdom, LS9 7TF
- St James's Hopsital
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Leicester, United Kingdom, LE1 5WW
- University Hospital of Leicester NHS Trust
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London, United Kingdom, SW3 6JJ
- The Royal Marsden NHS Foundation Trust
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London, United Kingdom, SE1 9RT
- Guy's and St Thomas' NHS Foundation Trust
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London, United Kingdom, NW1 2BU
- University College London Hospital
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London, United Kingdom, EC1M 6BQ
- St Bartholomew Hospital
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London, United Kingdom, W2 1NY
- Imperial College Hospital
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Manchester, United Kingdom, M20 4BX
- The Christie Hospital
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Manchester, United Kingdom, M13 9WL
- Central Manchester Univeristy Hospital NHS Trust
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Oxford, United Kingdom, OX3 7LE
- Churchill Hospital
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Sheffield, United Kingdom, S10 2RB
- Sheffield Teaching Hospitals NHS FoundationTrust
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Stockton-on-Tees, United Kingdom, TS19 8PE
- University Hospital of North Tees
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Wolverhampton, United Kingdom, WV10 0QP
- New Cross Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with symptomatic multiple myeloma (according to International Myeloma Working Group (IMWG) 2009 criteria) and have measurable disease
- Participants must require therapy for relapsed and/or refractory disease
- Participants must have received ≥ 2 treatment lines of anti-myeloma therapy (induction therapy followed by autologous stem-cell transplantation (ASCT) and consolidation/maintenance will be considered as one line).
- Participants must have received prior treatment with both lenalidomide and proteasome inhibitor, either as single agents or in combination regimens
All participants must have failed treatment with either lenalidomide and proteasome inhibitor in one of the following ways:
- Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or proteasome inhibitor ; or
- In case of prior response [≥ partial response (PR)] to lenalidomide or proteasome inhibitor, participants must have relapsed within 6 months after stopping treatment with lenalidomide and/or proteasome inhibitor containing regimens; or
- Participants who have not had a ≥ minimal response (MR) despite receiving at least 4 cycles of treatment or who have developed intolerance/toxicity after a minimum of two cycles of lenalidomide and/or proteasome inhibitor containing regimen
Patients must have received adequate prior alkylator therapy in one of the following ways
- As part of a stem cell transplant; or
- A minimum of 4 consecutive cycles of an alkylator based therapy; or
- Progression on treatment with an alkylator; provided that the participant received at least 2 cycles of an alkylator containing therapy.
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Required laboratory values within 14 days of treatment:
- Absolute neutrophil count ≥ 1.0 x109 /L (growth factor support is permitted)
- Platelet count ≥ 30 x 109/L (platelet transfusion is permitted)
- Creatinine clearance > 30 mL/min
- Corrected serum calcium ≤ 3.5 mmol/L
- Haemoglobin ≥ 8 g/dL (blood transfusion support is permitted)
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) < 3 times Upper Limit of Normal (ULN)
- Serum total bilirubin < 17 µmol/l
- Participants must consent to provide the bone marrow samples specified at screening and throughout the trial, in order to enter the trial. Confirmation of receipt of the sample from the lab must be received before treatment commences..
- Able to give informed consent and willing to follow trial protocol
- Aged over 18 or over
- Females of childbearing potential (FCBP) must agree to utilise one reliable form of contraception for 28 days prior to starting trial treatment, during the trial, and for 28 days after trial treatment discontinuation and even in the case of dose interruption and must agree to regular 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 during the trial, including during any 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 donation blood while on trial drug, including during dose interruptions and for 28 days after discontinuation from this trial
Exclusion Criteria:
- Previous therapy with pomalidomide
- Hypersensitivity to thalidomide, lenalidomide, cyclophosphamide or dexamethasone
- Participants with non-secretory multiple myeloma
- Peripheral neuropathy ≥ Grade 3
- Participants who have received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
- Participants who are planned for a stem cell transplant post MUK Seven trial treatment
- Antitumour therapies including investigational medicinal products at any dose within 28 days before the start of protocol treatment (or 5 half-lives, whichever is longer). Bisphosphonates for bone disease and radiotherapy for palliative intent are permitted.
Participants with any of the following
- Uncontrolled congestive heart failure
- Myocardial infarction within 12 months prior to starting trial treatment
- Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris.
- Participants with gastrointestinal disease that may significantly alter absorption of pomalidomide
- Participants with a history of other malignancies within 5 years before the date of study entry (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that is considered cured with minimal risk of recurrence within 5 years).
- Participants unable or unwilling to undergo antithrombotic prophylactic treatment
- Pregnant or breastfeeding females
- Participants known to be seropositive for HIV, or active infectious hepatitis A, B or C
- Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pomalidomide and Dexamethasone
Pomalidomide and Dexamethasone will be administered as part of a 28 day cycle. Patients will continue with their treatment until disease progression, intolerance, toxicity or withdrawal. Dosing schedule:
|
Chemotherapy
Chemotherapy
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Experimental: Pomalidomide Dexamethasone Cyclophosphamide
Pomalidomide, Dexamethasone and Cyclophosphamide will be administered as part of a 28 day cycle. Patients will continue with their treatment until disease progression, intolerance, toxicity or withdrawal. Dosing schedule:
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Chemotherapy
Chemotherapy
Chemotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: From randomisation up to 72 months
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To determine whether the addition of cyclophosphamide to pomalidomide and dexamethasone (CPD) improves progression-free survival in patients with relapsed refractory myeloma (RRMM) in the UK, compared to pomalidomide and dexamethasone (Pd) alone
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From randomisation up to 72 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum response overall
Time Frame: From the start of treatment up to 72 months
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To determine the maximum response achieved from treatment
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From the start of treatment up to 72 months
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Response to treatment
Time Frame: From the start of treatment up to 72 months
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Determine the response to treatment
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From the start of treatment up to 72 months
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Clinical benefit rate overall
Time Frame: From the start of treatment up to 72 months
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Determine any clinical benefit that is derived from treatment
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From the start of treatment up to 72 months
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Time to maximum response
Time Frame: From the start of treatment up to 72 months
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Determine the time to maximum response to treatment
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From the start of treatment up to 72 months
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Duration of response
Time Frame: From the start of treatment up to 72 months
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Determine the duration that the response to treatment lasts for
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From the start of treatment up to 72 months
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Overall survival
Time Frame: Date of randomisation to death, up to 72 months
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Determine overall survival for all patients that receive treatment
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Date of randomisation to death, up to 72 months
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Treatment compliance
Time Frame: From the start of treatment up to end of treatment
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Measured by treatment delays and missed treatment doses
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From the start of treatment up to end of treatment
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Safety and Toxicity
Time Frame: Time of registration to 28 days post treatment discontinuation
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Measured by adverse reactions and serious adverse event reporting
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Time of registration to 28 days post treatment discontinuation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin Kaiser, Dr, Royal Marsden NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dexamethasone
- Cyclophosphamide
- Pomalidomide
Other Study ID Numbers
- HM13/10758
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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