J-MEN 010 STUDY
- Conditions
- Relapse and Refractory Multiple Myeloma
- Registration Number
- JPRN-jRCTs031180315
- Lead Sponsor
- Ishida Tadao
- Brief Summary
We started this study in order to assess the overall response rate after pomalidomide (P)/dexamethasone (D) treatment in relapsed multiple myeloma as primary endpoint, and the overall response after P/bortezomib/D treatment in patients who were not achieved response with P/D treatment as secondary endpoint; however the enough cases were not collected because of many pharmaceutical trials of new agents and induction of new effective agents for myeloma, and the study had to be canceled.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 7
1)Relapsed/refractory multiple myeloma diagnosed according to IMWG criteria and previously treated with bortezomib and lenalidomide.
2)Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
1.Serum M-protein >=0.5g/dL
2.In subjects without detectable serum M-protein, Urine M-protein >=200mg/24 hour, or serum free light chain (sFLC) > 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio
3)Can receive up to 4 lines of prior treatment. (Induction therapy followed by stem cell transplantation and consolidation/maintenance therapy will be considered as one line of treatment)
4)20 years old or more
5)ECOG Performance status 0 or 1 or 2
6)Patients must meet the following clinical laboratory criteria with 21 days of starting treatment
1.Absolute neutrophil count (ANC) >=1,000/mm3 and platelet >=50,000/mm3 (>=30,000/mm3 if myeloma involvement in the bone marrow is >=50% )
2.Total bilirubin <=1.5 x the upper limit of the normal range (ULN) . Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 x ULN .
3.Calculated creatinine clearance >=30mL/min or creatinine <=3mg/dL .
7)Adhere to RevMate
8)Written informed consent
1)Female patients who are lactating or pregnant
2)Multiple Myeloma of IgM subtype
3)Patients with myelodysplastic syndromes
4)POEMS syndrome
5)Patients with plasma cell leukemia
6)Waldenstrom's Macroglobulinaemia
7)Patients with known amyloidosis
8)Patients with GVHD
9)Patients with cataract
10)Glucocorticoid therapy (prednisolone >=30mg/day) within 14 days prior to informed consent obtained
11)Chemotherapy with approved within 21 days prior to starting pomalidomide treatment
12)Focal radiation therapy within 7 days prior to start of pomalidomide (Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of pomalidomide)
13)Major surgery (excluding kyphoplasty) within 28 days prior to start of pomalidomide
14)Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention
15)HBs antigen positive, HCV antibody positive, HIV antibody positive
16)Malignancy within the past 3 years except:
1.Adequately treated basal cell or squamous cell skin cancer
2.Carcinoma in situ of the cervix, gastric cancer, colorectal cancer
3.Breast carcinoma in situ with full surgical resection
17)Patients with steroid, lenalidomide, bortezomib hypersensitivity
18)Prior treatment with pomalidomide
19)Peripheral neuropathy >= Grade 2
20)Un-controlled liver dysfunction, renal dysfunction, heart failure, lung dysfunction, diabetes, hypertension
21)Active infection
22)Myocardial infarction within 4 months or deep vein thrombosis, pulmonary embolism within 3 years prior to informed consent
23)Interstitial pneumonitis, pulmonary fibrosis, abnormal interstitial shadow by CT scan
24)Inappropriate for study by any reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method