Prospective Follow-up of Relapse Myeloma Patients after Previous Exposure to Bortezomib and Lenalidomide Treated on Pomalidomide and Dexamethasone
- Conditions
- relapsed multiple myeloma
- Registration Number
- JPRN-UMIN000018405
- Lead Sponsor
- PO Epidemiological and Clinical Research Information Network (ECRIN)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1)Female patients who are lactating or pregnant 2)Multiple Myeloma of IgM subtype 3)Glucocorticoid therapy within 14 days 4)POEMS syndrome 5)Plasma cell leukemia or circulating plasma cells more than 2 x 109/L 6)Macroglobulinaemia 7)Known amyloidosis 8)Chemotherapy with anticancer therapeutics within 21 days prior to starting pomalidomide treatment 9)Focal radiation therapy or radiation therapy to an extended field. 10)Immunotherapy 11)Major surgery within 28 days 12)Active CHF, symptomatic ischaemia, or conduction abnormalities. Myocardial infarction within 4 months prior. 13)Known HIV, HCV, HBV-positivity. (except for patients with HBs-Ag or HBc-Ab responding to antiviral therapy: these patients are allowed) 14) Known cirrhosis 15)Second malignancy within the past 3 years. 16)Patients with MDS 17)Patients with steroid or lenalidomide hypersensitivity 18)Prior treatment with pomalidomide 19)Ongoing GVHD 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 o assess the progression free survival (PFS) for pomalidomide and dexamethasone in patients who have relapsed and are refractory to lenalidomide and have previously been treated with bortezomib.
- Secondary Outcome Measures
Name Time Method (1)Overall Response Rate (ORR) (2)To see if addition of cyclophosphamide will induce additional response in patient who do not achieve an minimal response (MR) after 3 months (3)Overall Survival (OS) (4)Duration of Response (DOR) (5)Safety and Tolerability