Randomized Phase 3 study of Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) versus Pomalidomide-Dexamethasone (PD) in relapse or refractory myeloma. An AMN003 study
- Conditions
- Relapse or refractory myeloma
- Registration Number
- JPRN-UMIN000027780
- Lead Sponsor
- EP-CRSU Co.,Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 11
Not provided
1.Female patients who are lactating or pregnant 2.Multiple Myeloma of IgM subtype 3.Glucocorticoid therapy within14days 4.POEMS syndrome 5.Plasma cell leukemia or circulating plasma cells more than 2x109/L 6.Waldenstrom's Macroglobulinaemia 7.Patients with known amyloidosis 8.Chemotherapy with approved or investigation anticancer therapeutics within21days prior tostarting pomalidomide treatment 9.Focal radiation therapy within7days prior to start of pomalidomide.Radiation therapy to an extended field involving a significant volume of bone marrow within21days prior to start of pomalidomide 10.Immunotherapy 11.Major surgery within28days 12.ActiveCHF, symptomatic is chaemia,or conduction abnormalities. Myocardial infarction within4months prior 13.KnownHIV seropositive,hepatitis C infection,and/or hepatitis B(except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B these patients are allowed) 14.Patients with known cirrhosis 15.Second malignancy within the past3years16.Patients with MDS 17.Patients with steroid or lenalidomide hypersensitivity 18.Prior treatment with pomalidomide 19.OngoingGVHD 20.Patients with pleural effusions or ascites 21.Contraindication to any of the required concomitant drugs or supportive treatments 22.Any clinically significant medical disease or psychiatric condition
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method