Phase II Randomised Trial of Cyclophosphamide and Dexamethasone in Combinat... | Recruiting
Phase II Randomised Trial of Cyclop... | Recruiting
Phase II Randomised Trial of Cyclophosphamide and Dexamethasone in Combination With Ixazomib in Relapsed or Refractory Multiple Myeloma.
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Medical Conditions
  • Multiple Myeloma
Primary Contact Details
Debbie Sherratt
39141 0113 343 1477
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02461888
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 evaluates a new treatment combination of ixazomib with cyclophosphamide and dexamethasone in relapsed or refractory multiple myeloma. Participants will either receive ixazomib with cyclophosphamide and dexamethasone or cyclophosphamide and dexamethasone alone.
Research Details
  • Cyclophosphamide and dexamethasone are very commonly used in the treatment of multiple myeloma and are often given with a third drug (e.g. thalidomide, lenalidomide or bortezomib). The combination of conventional and new drugs has provided benefits in both overall survival and progression free survival, however there are few treatments available for patients who have not responded well (refractory) to their previous treatment or who need further treatment because their myeloma has come back (relapsed). Thus there is a need for new agents for these patients.

    The development of ixazomib provides the opportunity to increase anti-tumour activity against a wider range of tumour types. Early clinical trials data suggests it has anti-tumour activity in heavily pre-treated multiple myeloma patients with durable responses/disease control and is generally well tolerated.

    Cyclophosphamide and dexamethasone are both predominantly used in treatment of multiple myeloma and for patients with relapsed or refractory multiple myelomas (RRMM), who have relapsed after bortezomib and lenalidomide. Therefore the evaluation of ixazomib in combination with cyclophosphamide and dexamethasone is the most valuable and practical option for patients.

    The primary end point of this study is progression-free survival (PFS). Secondary end points include toxicity and safety.
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Ixazomib, Drug : Cyclophosphamide, Drug : Dexamethasone

Study Arm Groups : Ixazomib, CD, Ixazomib, CD, CD, Ixazomib, CD, CD

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression free survival; From randomisation to first documented evidence of disease progression or death, up to 36 months.
Secondary Outcome Measures
    Response to treatment; From initial trial treatment until at least partial response is achieved, up to 36 months..; Maximum response; From initial trial treatment each of the response categories are achieved stringent complete response, complete response, very good partial response, partial response, minimal response or stable disease, up to 36 months.; Time to progression; From randomisation to first documented evidence of disease progression, up to 36 months..; Time to maximum response; From randomisation until the participant achieves any of the categories stringent complete response, complete response, very good partial response, partial response, minimal response or stable disease, up to 36 months.; Response duration; From the first observation of at least partial response until disease progression, up to 36 months.; Overall survival; From randomisation to death, up to 36 months.; Evaluate the safety and toxicity as measured by adverse reactions and serious adverse event reporting.; From consent until 28 days after the last dose of trial treatment, up to 36 months.; Treatment compliance measured by treatment delays and missed treatment doses.; From initial treatment received as per protocol until withdrawal from treatment, up to 36 months.; Quality of life measured by the completion of EQ-5D and EORTC QLQ-C30 questionnaires; Completed every 3 months from consent until disease progression, up to 36 months.; Cost effectiveness of treatment assessed by health economic evaluations.; From consent up to 36 months.
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:

    - Able to give informed consent and willing to follow study protocol assessments

    - Aged 18 years or over

    - Participants with confirmed multiple myeloma based on International Myeloma Working Group (IMWG) criteria, 2009

    - Measurable disease

    - Participants with relapsed or relapsed refractory myeloma and now require further treatment following exposure to thalidomide, lenalidomide and bortezomib regardless of response to these

    - Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

    - Required laboratory values within 14 days prior to Randomisation:

    - Platelet count ≥50x109/L. Platelet support is permitted within 14 days prior to Randomisation

    - Absolute neutrophil count ≥1.0 x 109/L

    - Haemoglobin > 9 g/dL. Blood support is permitted

    - Alanine aminotransferase (ALT) and / or Aspartate aminotransferase (AST) ≤3 x upper limit of normal

    - Creatinine clearance ≥ 30 ml/min (using Cockcroft Gault formula)

    - Bilirubin ≤1.5 x upper limit of normal

    - Both non-sterilised and sterilised females and males of reproductive age should use effective methods of contraception during the entire trial treatment (including treatment breaks) and up to 90 days after the last dose of trial treatment

    - Post allograft patients may be included

    Exclusion Criteria:

    - Those with non-measurable disease

    - Those with a solitary bone or solitary extramedullary plasmacytoma

    - Plasma cell leukaemia

    - Prior malignancy other than those treated with curative surgery.

    - Participants with a known or underlying uncontrolled concurrent illness that, in the investigators opinion, would make the administration of the study drug hazardous or circumstances that could limit compliance with the study

    - Patients who have previously received MLN9708/Ixazomib in a trial. Previous experimental agents or approved anti-tumour treatment within 30 days before the date of randomisation.

    - A maximum of 160mg of dexamethasone (in 40mg blocks) may be given between screening and the beginning of treatment if medically required but should be stopped before trial treatment starts. Bisphosphonates for bone disease and radiotherapy for palliative intent are also permitted

    - Participants with a history of a refractory nausea, diarrhoea, vomiting, malabsorption, gastrointestinal surgery or other procedures that might, in the opinion of the Investigator, interfere with the absorption or swallowing of the study drug(s)

    - Peripheral neuropathy of ≥ grade 2 severity

    - Gastrointestinal disorders that may interfere with absorption of the study drug

    - Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B or C) hepatitis

    - Female patients who are lactating or have a positive serum pregnancy test during the screening period

    - Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent

    - Systemic treatment, within 14 days before the first dose of MLN9708, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort

    - Major surgery within 14 days prior to the date of randomisation

    - Radiotherapy within 14 days prior to randomisation

    - Disease involving the Central Nervous System
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
London
E1 1BB
GSK Investigational Site
London
W2 1NY
Manchester
M20 4BX
Southampton General Hospital
Southampton
England
SO16 6YD
Birmingham
B15 2TH
Nottingham
NG7 2UH
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Guy's Hospital
London
SE1 9RT
Novartis Investigative Site
Wolverhampton
WV10 0QP
London
NW1 2PG
Bristol
BS1 3NU
Liverpool
Merseyside
L7 8XP
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Sheffield Kidney Institute
Sheffield
S5 7AU
Royal Bournemouth Hospital
Bournemouth
Dorset
BH7 7DW
Churchill Hospital
Oxford
OX3 7LE
Hartlepool
TS24 9AH
Birmingham Heartlands Hospital
Bordesley Green
England
B9 5ST
Trial Contact(s)
Primary Trial Contact
Debbie Sherratt
39141 0113 343 1477
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
A Randomised Phase II Trial of Cyclophosphamide and Dexamethasone in Combination With Ixazomib in Relapsed or Refractory Multiple Myeloma (RRMM) Patients Who Have Relapsed After Treatment With Thalidomide, Lenalidomide and Bortezomib.
EudraCT Number
Not available for this trial
Funder(s)
  • Myeloma UK
  • Millennium Pharmaceuticals, Inc.
Other Study ID Numbers
HM13/10993
Sponsor(s)
University of Leeds
Key Dates

Recruitment Start Date

Dec 2015

Recruitment End Date

May 2018

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

01 Jun 2015

Date updated in source

16 Nov 2016