Randomised comparisons, in myeloma patients of all ages, of thalidomide, lenalidomide, carfilzomib and bortezomib induction combinations, and of lenalidomide and combination lenalidomide vorinostat as maintenance - Myeloma XI
- Conditions
- ewly diagnosed patients with symptomatic myelomaMedDRA version: 16.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
- Registration Number
- EUCTR2009-010956-93-GB
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 4000
1. Aged 18 years or greater 2. Newly diagnosed as having symptomatic multiple myeloma or non-secretory multiple myeloma based on: o Paraprotein (M-protein) in serum and/or urine o Bone marrow clonal plasma cells or plasmacytoma o Related organ or tissue impairment and/or symptoms considered by the clinician to be myeloma related 3. Provide written informed consent 4. Women of childbearing potential and male patients whose partner is a woman of child bearing potential must be prepared to use contraception in accordance with (and consent to) the Celgene approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention, or commit to absolute and continuous abstinence. 5. Women of child bearing potential must have a negative pregnancy test in accordance with the Celgene approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
1. Asymptomatic myeloma 2. Solitary plasmacytoma of bone. (Patients with previous solitary plasmacytoma that have now progressed to symptomatic or non-secretory myeloma are eligible). 3. Extramedullary plasmacytoma (without evidence of myeloma) 4. Previous (<5 years since diagnosis) or concurrent active malignancies, except* surgically-removed basal or squamous cell carcinoma of the skin, treated carcinoma in situ of the breast of cervix, or incidental histologic finding of prostate cancer (TMN stage of T1a or 1b). Patients with remote histories (>5 years) of other cured malignancies may be entered.* *Entry of patients with the permitted previous malignancies is at the discretion of the local investigator, in light of the potential increased risk of second malignancy in patients treated with lenalidomide. 5. Documented diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) criteria for high-risk disease 6. Previous treatment for myeloma, except the following: o local radiotherapy to relieve bone pain or spinal cord compression o prior bisphosphonate treatment o corticosteroids 6. Known history of allergy contributable to compounds containing boron or mannitol 7. Grade 2 or greater (NCI criteria) peripheral neuropathy 8. Caution is advised in patients with a past history of ischaemic heart disease, pericardial disease, acute diffuse infiltrative pulmonary disease or psychiatric disorders, evidence of impaired marrow function or elevated liver function tests, but exclusion is essentially to be at the discretion of the treating clinician 9. Acute renal failure (unresponsive to up to 72 hours of rehydration, characterised by creatinine >500µmol/l or urine output <400ml/day or requirement for dialysis) 10. Lactating or breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare a thalidomide-containing regimen with two lenalidomide-containing regimens as induction treatment and to assess the value of lenalidomide maintenance for patients with newly diagnosed myeloma with respect to overall and progression free survival.;Secondary Objective: To assess response and toxicity to induction chemotherapy, maintenance chemotherapy and response to a novel agent bortezomib for patients whose response to induction chemotherapy is sub-optimal.;Primary end point(s): Overall survival Progression-free survival This trial is designed with overall and progression-free survival as joint primary endpoints.
- Secondary Outcome Measures
Name Time Method