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
- Conditions
- Haematological OncologyMyelomaCancerMultiple myeloma
- Registration Number
- ISRCTN17354232
- Lead Sponsor
- niversity of Leeds (UK)
- Brief Summary
1. 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method