Phase II Randomised Trial of Cyclophosphamide & Dexamethasone in Combination With Ixazomib in Rel… (NCT02461888) | Clinical Trial Compass
CompletedPhase 2
Phase II Randomised Trial of Cyclophosphamide & Dexamethasone in Combination With Ixazomib in Relapsed or Refractory Multiple Myeloma.
United Kingdom112 participantsStarted 2015-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
Progression free survival
Timeframe: From randomisation to first documented evidence of disease progression or death, up to 36 months.