Modified Bortezomib-based Combination Therapy for Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT02559154
- Lead Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Brief Summary
To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.
- Detailed Description
Multiple myeloma (MM) is a common hematological malignancy in Chinese elderly population. The application of novel drugs improved the clinical outcome and survival of MM patients,even though MM remains an incurable hematological malignancy. Bortezomib is a typical one among these novel agents, its application resulted in great success, but its adverse events and high expense restricted its widely usage. Investigators modified the dose and frequency of bortezomib administration in combination therapy: Patients in the modified group received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide，while patients in the control group received similar combination therapy except with conventional bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11.
The aim of this study is to investigate whether the modified bortezomib-based therapy may attain a similar efficacy as the conventional ones.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
-
Diagnosis of multiple myeloma based on standard diagnosis criteria:
- plasmacytomas on tissue biopsy
- bone marrow plasmacytosis
- monoclonal immunoglobulin spike on serum electrophoresis
- lytic bone lesions.
-
Must have relapsed or relapsed/refractory disease
-
18 years of age or older
-
All baseline studies must be performed within 21 days of enrollment.
-
ECOG performance status of 0 to 2
- Renal insufficiency (serum creatinine levels > 2mg/dL)
- Concomitant therapy medications that include corticosteroids
- Peripheral neuropathy of Grade 3 or greater or painful Grade 2
- Evidence of mucosal or internal bleeding and/or platelet refractory
- ANC < 1000 cells/mm3
- Hemoglobin < 8.0 g/dL
- AST (SGOT and ALT) > 2 x ULN
- Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol
- Known hypersensitivity to thalidomide or the development of erythema nodosum
- Active infection or serious co-morbid medical condition
- Pregnant or breast-feeding women
- Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description conventional BZ group Bortezomib Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide conventional BZ group Mitoxsnteone Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide modified BZ group Dexamethasone Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide modified BZ group Doxorubicin Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide modified BZ group Cyclophosphamide Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide modified BZ group Mitoxsnteone Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide conventional BZ group Dexamethasone Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide modified BZ group Thalidomide Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide modified BZ group Bortezomib Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide conventional BZ group Doxorubicin Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide conventional BZ group Cyclophosphamide Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide conventional BZ group Thalidomide Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide
- Primary Outcome Measures
Name Time Method disease responses to treatment one year Response evaluated by changes of serum M-component(g/L) through Serum quantitative immunoglobulins and Serum immunofixation electrophoresis.
(g/L)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai General Hospital
🇨🇳Shanghai, China