Induction of remission using the three drug chemotherapy regimen of Bortezomib-Dexamethasone-Pomalidomide in patients with newly diagnosed multiple myeloma
- Conditions
- Health Condition 1: C900- Multiple myeloma
- Registration Number
- CTRI/2020/09/027547
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Eligible patients are those with
1.Newly diagnosed, treatment-naive multiple myeloma (as defined by the IMWG Criteria), who are of age >= 18years and <75years, belonging to both sexes
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 <3 x ULN
d.Creatinine clearance >=15ml/min
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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