ISRCTN17354232CompletedPhase 2
A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs cyclophosphamide, velcade and dexamethasone (CVD) for first relapse or primary refractory multiple myeloma
niversity of Leeds (UK)0 sites300 target enrollmentStarted: December 12, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
- 2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27190631 2. 2017 results presented at ASH in http://www.bloodjournal.org/content/130/Suppl_1/835
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Syptomatic multiple myeloma and requiring therapy for first relapse or primary refractory disease
- •2. Measurable disease
- •3. Age = 18 years
- •4. Life expectancy = 6 months
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0?2
- •6. Adequate hepatic function, with serum ALT = 3.5 times the upper limit of normal and serum direct bilirubin = 2 mg/dL (34 µmol/L) within 14 days prior to randomisation
- •7. Absolute neutrophil count (ANC) = 1.0 × 10^9/L within 14 days prior to randomisation (growth factor support is not permitted)
- •8. Haemoglobin = 8 g/dL (80 g/L) within 14 days prior to randomisation (participants may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines)
- •9. Platelet count = 75 × 10^9/L (= 50 × 10^9/L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to randomisation. Platelet support is not permitted.
- •10. Creatinine clearance (CrCl) = 15 mL/minute within 14 days prior to randomisation, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
- •11. Written informed consent
- •12. Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception.
- •13. Male participants must agree to practice contraception
Exclusion Criteria
- •1. Non-secretory multiple myeloma
- •2. Extramedullary plasmacytoma (without evidence of myeloma)
- •3. Received therapy for their first relapsed or primary refractory disease other than local radiotherapy, therapeutic plasma exchange, or dexamethasone up to a maximum of 200mg
- •4. Pregnant or lactating females
- •5. Major surgery within 21 days prior to randomisation
- •6. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomisation
- •7. Known human immunodeficiency virus infection
- •8. Active hepatitis B or C infection
- •9. Unstable angina or myocardial infarction within 4 months prior to randomization, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless participant has a pacemaker
- •10. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomisation
- •11. Previous or concurrent active malignancy within the past 3 years with the exception of:
- •11.1 Adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer
- •11.2. Carcinoma in situ of the cervix or breast
- •11.3. Prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels
- •11.4. Cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localised transitional cell carcinoma of the bladder or benign tumours of the adrenal or pancreas
- •12. Significant neuropathy (Grades 3?4, or Grade 2 with pain) within 14 days prior to randomisation
- •13. Patients with haemorrhagic cystitis
- •14. Known history of hypersensitivity to any of the study medications or excipients
- •15. Participants undergoing active treatment for infiltrative lung disease
- •16. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment
- •17. Contraindication to IV hydration programme
- •18. Participants with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomisation
- •19. Any other clinically significant medical disease or condition that, in the Investigator?s opinion, may interfere with protocol adherence or a participant?s ability to give informed consent
Investigators
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