Pomalidomide in Relapsed and Refractory Multiple Myeloma (RRMM) | Recruiting
Pomalidomide in Relapsed and Refrac... | Recruiting
Pomalidomide in Relapsed and Refractory Multiple Myeloma (RRMM)
MUKseven

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Medical Conditions
  • Multiple Myeloma
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02406222
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
This study is determining whether the addition of cyclophosphamide to pomalidomide and dexamethasone improves progression free survival in patients with relapsed refractory myeloma (RRMM) compare to pomalidomide and dexamethasone alone. Patients will be randomised on a 1:1 basis to receive CPD or Pd. Treatment will be continued until disease progression or unacceptable toxicity.
Research Details
  • Multiple myeloma is the second most common hematologic malignancy in the European Union (EU), responsible for an estimated 21,000 deaths in the EU in 2008. For patients that relapse or are refractory to current standard treatment (combination of bortezomib/lenalidomide, dexamethasone and an alkylating agent) there are few options available and therefore the prognosis within this group is often poor with response to treatment decreasing with successive relapses until resistant disease develops. . Current standard treatment at first relapse in the UK is the use of bortezomib in combination with dexamethasone and cyclophosphamide. Another common treatment is lenalidomide given with dexamethasone and cyclophosphamide. The addition of cyclophosphamide has demonstrated to improve treatment outcomes whilst being tolerated well. A recent clinical study has shown the addition of cyclophosphamide to the combination of pomalidomide and dexamethasone has shown to be safe and tolerable and beneficial in terms of treatment outcomes. The primary aim of this study is to investigate whether the addition of cyclophosphamide to pomalidomide and dexamethasone leads to an improved progression free survival. A secondary aim is to identify markers from clinical material that will predict response to pomalidomide in a group of relapsed and refractory multiple myeloma (RRMM) patients to provide important information for use in discussions with NICE on how best to improve the value and use of pomalidomide in the UK in the RRMM setting.
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Pomalidomide, Drug : Dexamethasone, Drug : Cyclophosphamide

Study Arm Groups : Pomalidomide and Dexamethasone, Pomalidomide Dexamethasone Cylcophosphamide, Pomalidomide and Dexamethasone, Pomalidomide Dexamethasone Cylcophosphamide, Pomalidomide Dexamethasone Cylcophosphamide

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression free survival; From randomisation up to 72 months
Secondary Outcome Measures
    Maximum response overall; From the start of treatment up to 72 months; Response to treatment; From the start of treatment up to 72 months; Clinical benefit rate overall; From the start of treatment up to 72 months; Time to maximum response; From the start of treatment up to 72 months; Duration of response; From the start of treatment up to 72 months; Overall survival; Date of randomisation to death, up to 72 months; Treatment compliance; From the start of treatment up to end of treatment; Safety and Toxicity; Time of registration to 28 days post treatment discontinuation
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
250
Participant Inclusion Criteria
    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:

    1. Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or proteasome inhibitor ; or

    2. 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

    3. 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

    1. As part of a stem cell transplant; or

    2. A minimum of 4 consecutive cycles of an alkylator based therapy; or

    3. 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

    1. Uncontrolled congestive heart failure

    2. Myocardial infarction within 12 months prior to starting trial treatment

    3. 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
Bordesley Green
B9 5SS
GSK Investigational Site
London
W2 1NY
Manchester
M20 4BX
Local Institution
Glasgow
Central
Oxford Road
Manchester
M13 9WL
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Birmingham
B15 2TH
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Guy's Hospital
London
SE1 9RT
Belfast
BT9 7AB
Novartis Investigative Site
Wolverhampton
WV10 0QP
Dundee
DD1 9SY
Brighton
BN2 5BE
Cardiff
CF14 4XW
Royal Free Hospital
London
NW1 2BU
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Stockton-on-Tees
TS19 8PE
Churchill Hospital
Oxford
OX3 7LE
London
EC1M 6BQ
Burton-on-Trent
DE13 0RB
Sheffield Teaching Hospitals NHS FoundationTrust
Sheffield
S10 2RB
Trial Contact(s)
Primary Trial Contact
Martin Kaiser
01133431477
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Pomalidomide in Relapsed and Refractory Multiple Myeloma (RRMM)
EudraCT Number
Not available for this trial
Funder(s)
  • Myeloma UK
  • Celgene
Other Study ID Numbers
HM13/10758
Sponsor(s)
University of Leeds
Key Dates

Recruitment Start Date

Mar 2016

Recruitment End Date

Mar 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

18 Feb 2015

Date updated in source

14 Jun 2017