Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: VPD Induction in Newly Diagnosed Multiple Myeloma: Induction of remission using combination chemotherapy with bortezomib, pomalidomide and dexamethasone in newly diagnoseed patients wi
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: Eligible patients are those with 1. Newly diagnosed, treatment-naive multiple myeloma (as defined by the IMWG Criteria), who are of age >= 18years and 2. ECOG performance status 0-2 3. Patients must meet the following laboratory criteria within 14days of treatment a. Absolute neutrophil count >=1000/L b. Platelet count >= 50,000/L c. Adequate hepatic function defined as TB, AST/ALT d. Creatinine clearance >=15ml/min
Exclusion criteria
Exclusion criteria: 1. Past history of plasmacytomas 2. Clinically relevant active infection or serious co-morbid medical or psychiatric illness 3. Pregnancy or lactation 4. Known hypersensitivity/contraindications to any of the drugs in the regimen 5. Known HIV infection, active hepatitis B or C viral infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of VPD induction on response rate in terms of â?¥VGPR among patients with Newly Diagnosed Multiple MyelomaTimepoint: Efficacy of VPD induction will be assessed using response rates at the end of 2cycles (8weeks) and at the end of 4cycles (16weeks) of induction. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the level of expression of cereblon, IRF4/MUM1 on myeloma cells by imunohisochemistry (IHC) at diagnosis and to identify its association with the response to pomalidomideTimepoint: Level of expression will be assessed at baseline and it will be correlated with response rates after 16weeks of VPD induction | — |
Countries
India
Contacts
Public ContactDr Fen Titty Saj
JIPMER Puducherry
Outcome results
None listed